CA2337665A1 - Method and system for facilitating clinical trial recruitment and for disease management and surveillance - Google Patents
Method and system for facilitating clinical trial recruitment and for disease management and surveillance Download PDFInfo
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- CA2337665A1 CA2337665A1 CA002337665A CA2337665A CA2337665A1 CA 2337665 A1 CA2337665 A1 CA 2337665A1 CA 002337665 A CA002337665 A CA 002337665A CA 2337665 A CA2337665 A CA 2337665A CA 2337665 A1 CA2337665 A1 CA 2337665A1
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- G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
- G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
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- G16H10/00—ICT specially adapted for the handling or processing of patient-related medical or healthcare data
- G16H10/60—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for patient-specific data, e.g. for electronic patient records
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Abstract
A system and method of facilitating the determination of candidates eligible for a clinical trial includes maintaining an electronic patient registry including patient information relating to a plurality of individuals. When individuals are needed for a clinical trial, the patient registry is searched based on criteria established for the clinical trial thereby to determine potential candidates within the patient registry that are eligible for the clinical trial. Individuals can register with the electronic registry on-line. A system and method for disease management and surveillance is also provided.
Description
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The present invention relates to a system and method of faeilitatiug the determination of candidates eligible for a clinical trial. The presewt invention also relates to a system and method for disease management and surveillance.
Clinical trials ate one ofthe final stages in lung processes aimed at improved disease therapy. Each clinical trial is designed to answer specific scientific qaestzans and so it is impartanrthat the candidates participating in the clinical trial reflect the target 1 t1 population. Preferably, each clinical trial 1S randomized tc~ reduce bias and increase the ability to generalise the results. There are different types of clinical trials (i.e. treatment trials, prevention trials, screening iz'ials and quality of life trials) arid different phase$ of clinical trials (i.e. Phase 1 (safety), Phase II (safety and efficacy), F~hase ~ (efl:aeacy and comparison) and phase 1V (post-approval marlCettug). As such, di#~erent types of candidates 15 are needed for the different types arid phases of clinical trials.
Studies are done an candidates who either volunteer or are paid to rake part in a clinical trial to determine t>ae suitability ofthe candidates far the clinical trial. The screening of candidates that are potential subjects is a curnbersotnet and time-consuming process, Rapid as:crual Qf candidates into clinical trials requires extraordinary access to patients and patient data. Access to patients and their data has in tlhe past been limited. Tpis of course has presented difficulties enrolling the necessary number of suitable candidates for clinical trials. The end result has simply lengthened the time required to complete cliztical trials. Tnis of course translates directly into an increase in the time to first patient metric for patients in the clinical trials.
25 In an attempt to alleviate this problem, commercial and non-profit enterprises have been established to assist in the recruitment of patients for clinical trials. For example, the Canadian HIV Trials Network is a non-profit Canadian organixatian dedicated to supporting clinical trials involving people with HIVIAiDs_ The ~auadian HIV
Trials Network maintains a database that lists national clinical trials- The database is accessible to 30 individuals on line.
The National Cancer Insrituie's Physician Data Querry (PDf~l) is a non-profit American organi2ation dedicated to supporting clinical trials itrvoYving people with cancer.
P~(2 maintains a database that provides a comprehensive list of clinical trials being inducted in the United States.
02-23-01 05:51pm From-SIM MCBURNEY 4185951163 T-Z53 P.05/39 F-T41 Commercial enterprises that have been established to assist in the recruitment of patiet7ts for clinical trials include general clinical trial management and ruarketing companies, on-lute clinical trial service sites axed on-line general ntedicai information sites.
Examples of general clinical trial management and marketing companies include ~uintilcs, Rheumatology Research International and Healthcare Communicanions Group.
The nn-line clinical trial service sites are primarily fiacused on clinical trials and generate revenues from drug development compatues for on-line marketing and recruitment. Examples of these on-line clinical trial service sites include Centerwatch, The Health Exchange and Medistudy.
The online general medical infr~rmatiart sites pffer listings atldlor active recruttraent ofpatients for clizucal trials. Examples of these on-lye general medical information sites include DrKoop and AmericasDactor.
In addition to the above-described enterprises, non-profit enterprises have also been established to register patient data that tray be useful in detetmittiug candidate suitability far clinical trials. >rxamgles of non-profit electronic registries include the North American Rheumatoid Arthritis Consortium (1VARAC) registry, tt~e American Rheumatism Association Medical Infotmati8ri System (ARA.MIS), the National Data dank for ltlteutxlatic Diseases (NDE) and the Analysis of Medical practice and Health ~Dutcames in Rheumatoid Arthritis (AMPHORA) Study. These non-profit electronic registries corapile information collected by physicians that relates to chronic diseases and are for the most part used by acadetxlic researchers.
to addition to the above nQn groi;it electronic registries, other electronic registries exist. For example, the Mayo Lung Cancer Specimen Registry is an investigational cancer registry that aol leas tissue samples and patient data for research and investigative purposes. The inforttaation and biological samples in the electronic registry are explicitly linked to development of the clinical trial process. The registry lisla Mayo-sponsored clinical trials and forms the foundation for current and future clinical trials for lung cancer performed by Mayo ~l.inic investigators.
Companies that collect biological samples and disease inforruation on a commercial basis to build ethnic population databases fox gene discovery, phaxmacogenomies artdlt~r therapeutic delivery based on genetic profile also exist. Examples of such camparfies include deCUhl? Genetics, Newfound Genomics, Myriad Genetics and Galileo Gerlomics;
and Framingham Cenotnics Medicix4e loc.
02-23-O1 05:51pm From-SIM MGBURNEY 4165951163 T-Z53 P.06/39 F-Z41 _3_ The databases associated with deGfJl~E .genetics, hfewfound Genomics, and Framingham Genamics Medicine inc. compile information on individuals, whether healthy ar diseased, of a spet:ifia ethnic or geogr2~pliical group and are not necessarily disease-based.
This approach is less amenable t4 use for clinical trials that depend on perfrarming trials in diseased individuals.
Myriad Genetics maintains a proprietary database for product discovery purposes axtd leverages its access to population-based databases to~ become a fully ~tegrated biopharmaceutical company involved irt gene discovery, drug target identificarion, drag development and phannacogenomic product development_ Although enterprises to assist it1 the secruittuent of candidates fox clit7.ical trials and to maintain elecirouic registries exist, these enterprises have trot increased the speed by which suitable candidates for clinical trials are enrolled to the extent desired. Thus, a need exists far irnpxovements in the manner by which potential candidates for clinical trials are deteramined.
There is also a need to evaluate the cost-effectivecte~ss of uew and old drugs, technologies and service to improve the quaiiry of care as well as health care policies at a lower cost than carxently exists. In order to achieve this, population-based data is very important to provide the desired accurate giobal picture. Although registries including population-based data axe available, problems exist in that the registries tend to have a ?0 selection bias_ While treatment and early prevention are itt3poitant, prevention of disease has the greatest patentiai to reduce the burden. As a result, there exists a raved for a disease management system that fosters the creation of a link between patients, clinicians, researchers and indu5try_ It is therefore an object of the present invention to provide a novel system and method of facilitating the determination of candidates eligible far :a clinical trial. It is also an object of the present invention to pmvide a navel system and method for disease management and surveillance.
9ummsrv Cff'ffee Invel According to one aspect of the pxesent invention there is provided a method of facilitating the determination of candidates eligible for a clinical trial comprising the steps of:
maintaining an electronic patient registry including patient information relating to a plurality of individuals; and 02-23-D1 05:52pm From-SIM MCBURNEY 4165951183 T-Z53 P.D7/39 F-141 _q._ when individuals are needed for a clinical trial, sea:cching the patient registry based on c~teria established far said clinical trial to determine potential candidates within said patient registry that ate eligible for said. clinical trial_ Preferably, the method fi,u~ther includes contacting the potential candidates to determine if the potential candidates wish to participate in the clinical trial. Consideration is obtained from the entity for conducting the search. The consideration in the preferred embodiment is a monetary fee-Preferably, the method ftuther includes the step of:maintainiug a clinical txial registry to receive ct-iteria for clinical trials from a plurality of entiaies wishing to conduct lfl clinical trials. It is also preferred that the method further includes maintaining a disease management re~~istty to store clinical development and pharrz~aceutical product information relating to clinical trials that have been cønductsd as well as disease surveillance data. The clinical development and pharmaceutical product information can be used by entities to generate pharmacoeconomi.e data and the disease swveillance data can be used to increase the IS efficiency oftherapeutie delivery toQls-According to arrQther aspect of the present inventiv~n there is provided a method for disease management comprising the steps of maintaining a database populated with patient-derived data relating to a canditian of interest, said patient-derived data being acquired fronn a pluraIiry of difference 2d sources; and providing said patient-derived data to as entity for study andlor analyxation.
The present invention provides advantages ixt that :since patient data entered into the electronic patient registry is automatically examined to de:tercnine if the patient data fits the inclusion and exclusion criteria of a clinical trial in the clitucal trial registry, eligible 25 candidates for clinical trials can be determined guickly and efficiently.
This of course allows candidates to be enrolled in clinical trials faster thereby significantly reducing the overall time taken to rcc:ruit far clinical trials. Clinical trials can be completed more quickly thereby reducing the tithe to fast patient metric far patients in the clinical trials.
Also, since patients can opt to participate in clinical trials on line, a comprehensive electronic patient registry is 30 maintained. This allows the search for candidates to be focussed, which speeds up the tecrwitment prbcess and reduces costs.
The present invention also provides advantages in that since the patient data in the electronic patient registry can be lin3ced to a biological sample registry, a comprehensive source of biological data for pharmacogenomic studies can be maintained.
02-23-01 05:52p~ From-SIM MCBORNEY 4165951163 T-T53 P.OB/39 F-T41 Brief ()eccrjg~io~0'~'~~P L?ra~ngs An erabadiznent of the present invention will now lbe described more fully with reference to the accompanying drawings in which:
Figure 1 is a schematic diagram of a system for facilitating clinical trial recruitment and disease martagetnent and surveillance;
Figure ? is a schetatatic diagram of a clinical trial srtbsystem and a disease Managetrtent subsystem forming part of the system of Figure 1;
Figures 3a tQ 3e are profile web pages completed by the system admnaistratbr 1Q in order to register a new physicianlinvestigator, sponsor and centre in the system csf Figure t;
Figure ~ is a block flaw diagram of information available to a sponsor accessing the system ofFigure 1 via an an-line ,lnternet cannectia;n;
Figure Sa is a query web page showing the inclusion and ~xchzsia~l ctiteria established for a query of an electronic patient registry;
Figure ~b is a web page showing the results of a query of the electrønic patient registiy~
Figure 6 is a block flow diagFam of information av.ailabie to a physicianlinvcstigator accessing the system Qf Figure 1 via an ox~-ltne Internet cann~tion;
Figures 7a to 7c show a clinical trial web page questionnaire completed by a gatient prior to partictpaiiug In a clinical trial; and Figure 8 is a block slow diagram of information available to a patiextt accessing the system of Figure 1. via an on-line Internet eonnectio:n.
Ailed Descrilrtian Of The Psefefred'~~~Lll ent The prese~rit invention relates to a Method and system for facilitating clinical trial recruitment and for disease management and surveillance relating to a particular condition of interest. The system maintains an electronic patient registry in which patient data associated with cansetuing patients that is received from physicians is stored_ The patient data stored in the electronic gatiextt registry can be searched against inclusion and exclusion criteria established by sponsors interested is sponsoring clinical trials to determine patients who fit the criteria. 'T'he system also maintains a database; that stores data relating to centres associated with the condition of interest, physicianslizmest;igators within the centres who conduct the clinical trials relating to the condition of interest and sponsors who sponsor 02-23-01 05:52pm From-SIM MCBURNEY 4165951163 T-753 P.D9/39 F-T41 clinical trials. Further specifics of the system will ww be described with reference to Figures ltoS.
Turning now to Figure 1, the system for facilitating clinical trial recruitrrlent and for disease managemexu and surveillance relating iv a particular condition of interest in accordance with the present invenrion is shown and is generally identified by reference numeral 14. In this particular embodiment, the system 14 facilitates clinical trial recruitment and disease management and surveillance relating to ltlteumatQtd Arthritis (RA). Th4se of skill in the art will however appreciate that the system 14 may be .set up to facilitate clinical trial recruitment and disease management and surveillance relatin~~ to basically any disease of interest.
As can be seen, system 10 includes a clinical trial subsystem 12, a disease management subsystem 14 and a disease surveillance subsystem lb. The clinical trial subsystem 12 commt~,nicates with a biological sample registry 2fl over a communications link. The elirxical trial subsystem 12 and the disease management subsystem 14 also communicate with clinical uial centre$ 22, clinical trial spp~ors 24, physicianslinvgators 26 and patients 2$ over communications networks. pisease surveillance system 16 receives-information from a government health database 18 and from patients 28.
The clinical trial subsystem 12 and the disease marnagement subsystem 14 are based on the Adaapt software platform created by FtrtpatheQn Inc. of California. This software platform integrates data &otn multiple and far reaching data sources, analyzes and toms the data into meaningful infon-tlatiott and personalizes the delivery of the meaningful information to users based on predefined user preferences. The Adaapt software platform provides built-in mufti-level security for information. This security includes transport-level security to encrypt tlae secure sQCket layer of the HTTP protocol during communications between web servers and client coxtlputer systems. A frewall is used to isolate database and file servers from the Internet. User-access protection by assigning; user ~
numbers and passwords and data level protectir~n by encrypting data with the system are also impler~nented.
Figure ~ better illetstxates the clinical trial subsystert~ 12 and the disease management subsystem.l4. As can be seen, clinical trial subsystem 12 includes a web server 30 and a fxx server 32, both ofwhich are coxtnected to database and file servers 34. Database and ale servers 34 manage an electronic patient registry 36 storing physician-derived patient data associated with patients 2s who suffer from kA_ ><n order for a physiciatx to add a patient to the electronic patient registry, the patient must first provide the physician 26 with informed 02-23-O1 05:53pm From-SIM MCBURNEY 4165951163 T-T53 P.10/39 F-Z41 consent. Qnce informed consent has been given, the physician cant enter physician,derived data associated with the patient into the electronic patient registry 36 through the completion of questionaires. The informed consent also allows the patient daa~a to be used to identify the patient's eligibility for a clinical trial. Each patient ZS whose patient dais is stored in the electronic patient rebistry 36 is assigned a unique patient ID number. In the present embodiment, the patient ID number uses 'patient billing numbers in link the physician-derived data with Federal and provincial health data. Unce the patient 28 has been assigned a patient 1Q numbc~; the patient can access the system 1~ an-line as will he described_ Database and file servers ~4 als4 manage a clinical trial registry 38 that stares a list of the clinical trials registered in the system 1 Q and a list of the sponsers 24 who have submitted the clinical trials. The clinical trials are submitted by staonsors who wish to use the electronic patient registry 3~ to determine potential candidates that are eligible foT the clinical finals. .teach clinical trial listed u~ the clinical trial registry 3$ is identified by title, summary, objective, trial start and end dates, enrollment start and completion date, inclusion and exclusion criteria, the investigators 26 who have agreed to conduct the clinical trial and profile infQrrnatiou identifying the sponsor 24 of the clinical trial. Each sponsor ?4 in the list is identified by sponsor 1D number, c4mpany name, lacauon and. contact particulars and status_ The clinical trial subsystem 12 allows sponsors 24 registered with the system 14 to submit clinical trials that include inclusion and exclusion criteria for candidates, to the subsystem. A manager at the clinical trial subsystem 12 stores thE' information in the clinical trial registry 38 and then uses this information to generate a query of the elecuonic patient registry 36 to determine quickly and efficiently the patients in the elecuonic patient registry who fit the criteria. The manager, in turn ztotifles the physicianslinvestigators 26 associated with the eligible patients and asks the physiciansJinvestigators 26 to conduct the clinical trial, and if yes then obtain regulatory approval for the clinical trial and contact the patients to recruit and enr41 the patients in the clinical trial.
The disease management subsystem I4 also includes a web server SO and a fax server 52, bath of which are connected to database and file sewers 54.
'fhe database and ~0 file servers S~ manage a disease management registry 56 that stores a list of the el3tttcal trial ceatres 2? and the phys;cians/investigatr~rs 26 associated with the centres who conduct clinical trials relating to RA. Each centre 22 in the list is assig~c~l a unique centse ID
number. Profile information identifying each centre 22 is also stared such as the name of the centre, location and contact particulars and status (l.c. whether the centre is active or 02-23-O1 05:53pm From-SIM MCBIIRNEY 4165951163 T-753 P.11/39 F-741 _g_ inactive). each physicianlinvestigator 26 in the list is assigned a w~ique i»vestigator ID
number. Profile infarznatio# identifying each physicianlinvestig$t:or is also stored such as the name of the investigator, location and cQUtact particulars, specialty and status (i.e. whether the centre is active or in lactive).
The disease managezrrent re,~istry 56 also stores patient-derived data and information that assists users to create policy and healthy enviromnents to lessen the burden of ~.A as well as information that helps users to choose lower risk behaviours chat will will lessen the burden ofi~. In tyis manner, the disease management: subsystem 14 can provide cost-effective clinical development aad product commercia.lisatiom information to users that 1 D fosters the creation of a link involving patients with RA, cliniciana, researchers and industry.
The patient-derived data in the. disease managemeat registry 56 and the physician-derived data in the eIecronic patient registry 36 that that relates to the same patient is linked. Thus, the disease management subsystem 14 provides patient-derived data as a product linked to pbysician-derived data when the data relates to ~e same patient.
The web servers 30 aad 50 allow patients 28, phys:icianslirtvesti~ators 36, sponsoxs ?4 arid centres 22 to access the subsystems 12 and 1~1 on-line over at1 Internet connectiorf through client corrtputer systems that execute web client applications in the farm of web browsers. As is well known, the Internet provides a backbone of high-speed data communication lines between frost computers that route data and messages using the ~'CpITi~
2U suite of protocols_ pig communications between the web servers 3U and 5U
and client computer systems, the web servers send web page source files than include Hypertext Markup language (HTML) code to the client computer systems in response to reduests generated by the web browsers. The HTML code received by the client computer systems causes the web browsers to display formatted web pages to the users of the client computer systems. This enables the users to access and interact with the subsystems 12 anal 14 through web-based graphical user interfaces.
The fag servers 32 and 52 allow infonnation received from patients 2~, physicianslinvestigators 26 and sponsors ?4, who do not have access to the Internet, to submit ixtformatian to the subsystems 12 and 14 by facsimile. Iu#ormhtion received by the fax servers 32 and 52 is scanned and conveyed to the appropriate datiibase server for storage in the appropriate revistry or database.
The biological sample registry 2d stares utzne, sen,tm and cell samples of blood and synomal fluid and surgical specimens associated with patients 28 in the electronic patient registry 36. The urine, serum and cell samples of blood and synovial fluid and D2-23-01 D5:54pm From-SIM MCBIlRNEY 4165951163 T-T53 P.12/39 F-T41 -g-surgical specimens are collected from patients 28 with theix consent. ';l'1re physician-derived data in the electronic patient registry 36 and the serum and cell samples in the biological sample reg~siry 20 that are associated with the same patient are linked thereby to er~hanee the urility and impact of the electronic patient registry 36. This is due: to the fact that the combinatio>1 of ghysician-derived patient data and biological data facilitates studies of bia-markers, genomies (the identification of disease associated genes) sad pharmacogenamics (the identification of genes associated with therapeutic outcomes).
The information stared in the registries 36 and 38 of subsystem 1~ aRd in the registry ~G of subsystem 14 is managed by a system administrator.
Physicianslinvestigators 26, sponsors 2~ and centres 2? wishing to be listed the system 10 must be registered.
Registration requires the submission of appropriate profile information referred to previously to the system administrator. This infatmation is used by the system administrator to complete and save profile forms. Figures 3a to 3e shave the profile forms completed by the system administrator in order to register a new ghysicianlinvestigatar 25, spansar 24 and eerrne 22. Physieians/investigators 26 and sponsors 24 who have registered with the system 10 axe assigned unique LD numbers and passwords that can be usexi to login into the system 10. The system administrator also has the necessary rights to acc~;ss all of the infortnatioxt in the regisuies 36 and 38 and the database 56. Thus, the system administrator can edit and delete the profiles associated with physieiatis/investigators 26, spc>nsors 24 and centres 23 that are stared in the database 56.
When a sponsor ?~ establishes an on-line Internet :session with the system 10 via their client computer system, by entering the utuform resource: locator (LTRL) of the system website into the web brawler, t#~e sponsor can Iog into the system 1U
by entering their 1~ number and password. once logged la, the spansar 24 has the option to access the 2S clinical trial subsystem 12 or the disease management subsystem 1~i as shown in Figure 4. If the sponsor 24 opts to access the clinical trial subsystem 12, the ponsar has access to clinical trial services (block 1 OU) including recruitment, cs~nsulting and tn~at~keting services [blocks 102 to 1 U5) provided by the system 12. If the sponsor ~4 selects the recruitment services 102, the sponsor is able to submit a clinical trial to the subsystem 12 for storage in the clinical trial registry 38. The sponsor 2~ is charged consideration in the firm of a monetary fee for submitting a clinical trial that results in a query of the electronic p~ltient registry 36 being trade.
louring submission of a clinical trial, the sponsor 24 cortipletes a profile far the clinical trial and classifies the clinical trial into one of three classifications, namely public, 02-23-01 05:54pm From-SIM N~BURNEY 4165951163 T-T53 P.13/39 F-741 summary and private. All physiciansli.uvestrgators 26 have acces:> to the profile of a public clinical trial. With respect to clinical trials classified as summary" only select physicianslinvestigatars have access to the profiles of these clinical trials.
Summary information concerning the clitaical trials is however available to all physicians/ittvestxgators ?6. With respect to clinical trials classified as private, only select physicianslinvesitgators have access to the profiles of these clinical trials. No information is available to non-selected physicianslinvestigators 26.
Once the sponsor 24 has subutitted a clinical trial, the manager stores the clinical trial in the registry 38 and then uses the inclusion and exclusion criteria in the 1 Q submitted clir#ical trial to perform a query of the electronic paxient registry 35. Daring the query process, the manager is presented with a query web page that exposes a search engine as shown in Figure Via. The search engine includes a number of criteria fields each with associated condition and value fields together with Boolean Iogic fields. The manager in turn enters the appropriate inforfnation into the fields and then links the fields with the appropriate 1 ~ Boolean logic to establish the itzclusion and exclusion criteria to be used during the ciuery.
The query is thsa initiated causing the search engine t4 duery the ~electror~ic patieas registry 3~ based on the established inclusion and exclusion criteria. When the query is .complete, the query results are presented to the manager on a web page as shown in figure Sb. As can be seen, the web page presents a list ofthe patients that fit the inclusion and exclusion criteria 20 and the status of the patients in the list (i.e. whether they have a~ned to participate in clinical trials).
Once the daery has been completed, the manager contacts them of ghysicianslinvestigators '?5 associated with the patients identified in the query to notify them of their patients that match inclusion and exclusion criteria for a clinical trial. The manager ?S asks the physicianslinvestigators 26 to agree t4 corrdttct the clinical trial, obtain regulatory approval to conduct the clinical trial and them enrol their patients in the cliztical tri$1.
In addition to the clinical trial services 100, the spa~nsor 24 cax~ view a list of their clinical trials stored izmhe clinical trial registry 38 (black l4fi).
The sponsor also has access to additional resources tblocic 110) as well as access to the profiles :~.ssociated with 30 their clinical trials stored in the clinical trial t~egist~y 38 (block l la)_ Information concerning the patients enrolled in the sponsor's clinical trial is also available. lfxhe sponsor wishes disease management data associated with these patients, the sponsor can pay a fee for this information.
D2-23-01 D5:54pm Frum-SIM MCBURNEY 4165951163 T-153 P.14/39 F-T41 if the sponsor 24 accesses the disease n~taxxagement subsystem 14, the spattsor has access to the list of centzes 22 and the list Qf the physicianslinvestigators '26 that are stored in ttte database 56 (blocks 114 and 116). The sponsor als4 ttas acce$s to recextt news relating, to 1zA that has been posted to the subsystem 14.
S When a physicianlttivestigator ?fl lags into the system 13, the physiciatylixlvestigatar is presented with a home page chat displays news and infortraation, new publications, reminders aztd messages to the physicianlinvesti,~ator 26. From the home page, the physicianlinvestigats~r 26 can navigate either to the clinical trial subsystem 12 or to the disease management system I4 as shown in Figure b- ~f the physiicianlinvestig~tar 26 r~pts tb 1U access the clinical trial subsystem 12, the physicianlinvestigatorhas access tc~ clinical txial services (blociG 200) that include recruitrneixt, consulting and marketing services (blocks 24?
to 206).
When the physicianlinvestigator ?~ is notified by the manager of their patients who fit the inclusion and exclusion criteria of clinical trials, if the 15 physiciauunvestigatox 26 is interested in conducting the clinical tidal and enrolling their patients, the physicianlinvestigator 26 must obtain regulatory approval for the clinical trial by submitting the appropriate forms, dealing with ethics, and executing the appropriate clinical trial agreements. Clzlce the physician/ittvestigator 25 has completed 113e regulatory requirements, the system. administrator adds the physicianlinvesti;~ator to the list in the 20 registry 56 for the clinical trial and euable$ the physician/investig~ator to enroll patients for the clinical trial.
In addition, the physicianlinvestigator 26 can view a list of the clinical trials stored in the clinical trial registry 38 (blocl~ 208). Through the clinical trial registry, the physicianlinvestigator can view the profiles of clinical trials designated as public and elittical ZS trials designated as summary and private for whom the physieian/investagator 26 has been selected (block 21 l))- Also, the physicianlinvestigator 26 can enter patient data fQr a uew patient wishing to participate in a clinical trial. The patient data is stored in the electronic patient registry 36. This is achieved by completing and $ubxrritting the appropriate form as shown in Figures 7a to 7e. As can be seen, the farm includes questions regarding what drugs 30 the patient is Qn, when they were started and stopped, and why they were stopped. These three questions plus erythrocyte sedimentation rotes, answers to the health assesment questionaire (HAQ) and azatiual X-rays enables the patient data in the electronic patient registry 36 to be used in conjunction with biological samples story.-d in the biological sample registry 24 fQr pharmacogenomtcs purposes. When patient data for the new patient coshing 02-23-01 05:55pm From-SIM MCBURNEY 4165951163 T-753 P.15/39 F-741 _I2_ to participate in a clinical trial is entered into the electronic patient registry 34, a query ofthc electronic patient registry can be made to detenrzzine if the patient data Fts the inclusion and exclusion criteria associated with any of the clinical trials in the c:~inical trial registry 38.
The physicianlinvestigator ?6 can also access information relating to the clinical trials in which the physicianlixtvestigator is currently pat~ticipaiing (block 214). This information includes general information about the clinical trial, the regulatory status of the clinical trial, a list of all the patients that the physicianlinvestigatox 26 has enrolled itt the clinical trial as well as a spy of the cumber of patients enrolled in the clinical trial by all other physicianslinvestigators.
1 p If the physicianlinvestigator 26 accesses the disuse uraxtagement subsystem 1 d, the physiciaminvestigacor has access to the list of centres 22 arid the list of investigators that are stoned in the registry 56 (blocks 220 and 222). ~'he physicianlinvestigator 2b also has access to recent news relating to R.A. that has been posted to the subsystem 14 (block 224). In ar~ditiop., the physicianlinvestigator can access a list of the physiei.anlirzvestigator's patients who are participating in clinical trials (block 2?6) but does not have access to dat$ from any other physician's patients- From the list, the investigator can see which clinical trials each patient is parcicipatizig in and car; access each patient's prbfile. The physicianlinvestigator can also access a search engine similar to that shown in Figure Sa and conduct querns ofthe patient data in the electronic patient registry 3b that is associated with the physicianlinvestigator's patients. 'flze patient's profile provides coptact information allowing the physzcianlinvestigatar to contact the patient directly (block 22$). Access to the patient's profile also allows the physician/invesrigator to update the patieril: data in the electronic patient registry 3s (block ?30).
The disease management subsystem 14 also provides an ethics area and a messaging area. The ethics area presents information relating to ethics committees, whether ethics memberships have been submitted to the system 10, the frequency of ethics meetings and the frequency of submissions far new proposals. The messagixzg area allows the plzysicianlirivestigator to send secure messages to the systwn administrator and to sponsors 2~4.
When a patient 28 accesses the system 10, the patient has the option to access the clinical trial subsystQm 12 or the disease management subsystem 14 as shown in Figure $.
if the patient opts to access the clinical trial subsystem 12, the patient can vices the list of clinical trials in the clinical trial registry 38 (block 300) and can elect to participate in a clinical trial by selecting a clinical trial from the list and completing and submitting a 02-23-O1 05:55pm From-SIM MCBURNEY 4165951163 T-T53 P.16/39 F-741 recruitment farm (block 302)- This changes the patient's status in the clectmnic patient registry 36 to active. The patient 28 can also access iufartttation c:onceming available clinical trials including a list of the centres 22 conducting clinical trials (block 304) and frequently asked guestions (block 306).
If the patient 28 opts to access the disease mattagecxtent subsystem 14, the patient can view thecr patient data that is scored in the electronic patient registry 36 (block 310) and. their physician's contact information to allow the patient to cQrttact their physician directly (block 313). The patient can also access the list of the ce:atres in the database Sb (block 314) and the list of physicianslinvestigators ?6 in the database 56 tbiock 3 3 b).
The system administrator moaitors the system 10 tutd generates reports on a regular basis for the sponsors 24 of clitucal trials. For each clinical trial, a report is generated that includes an update on the physicianslinvestigators regulatory status and the patient enrolment by each physielanlinvestigator fox the clinical uial.
As will he appreciated, the clinical trial subsystem 12 facilitates the I ~ recruitment of candidates for clinical trials thereby speeding up the recruitment time. This is due to the fact that patients can access the clinical trial subsystem 12 oa-liae and elect to participate in clinical trials. Patient data entered into the electroniic patiexlt registry is compared with the inclusion and exclusion criteria of clinical tria:~s allowing eligible candidates for the clinical trials to be d~termtned quickly and efficiently and them contacted to enrol in the clinical trials.
Although the ciitiical trial subsystem 12 is described as using a manager to populate rite clinical trial registry 3$, conduct the electronic patient registry query and botify physicianshnvestigators 20 if their patients ft the criteria of cliuic:al trials, those of skill in the art will appreciate that this process can be automated. In this wa5r, clinical trials can be submitted electronically to the clinical trial subsystem 1~ for stor,~ge in the clinical trial registry 38. fence in the clinical trial registry, the inclusive and exclusive criteria can be retrieved automatically and used during an electronic patient regi;suy query.
Physicianslinvestigatflrs whose patients fit the criteria can then be:
notified electronically.
Satellite terminals are installed at the offices and clinics of physicians/investigators 26 and execute web client applications such as web browsers. When a patient visits a physicianlinvestigator for an appointment, the patient is asked to access a health questionnaire (block 318) through the disease managemeztt system 14 and answer the questionnaire. Tlte information entered by the patient is incorporated into the database at the df~ce or clinic and is compared with prior data to generate a historical summary based on the 02-23-01 05:56pm From-SIM MCBURNEY 4165951163 T-153 P.iT/39 F-141 physician's preferences (i_e. medications, HALE score, pain scale,,joint count over time etc.).
The results of the comparison are presented to the physician in graphical format prior to the physician's meeting with the patient. This conserves tune fax the physician and the patient and provides the physician with a database tool that cart be used u~ better manage patient workload. Tile information is also transmitted to the system for storage in the registry 56.
The web >?rowser executed lay each satellite tetrriirial provides a bast of other useful Bilks that are customisable by the physicianlinvestigator. For example, the web client application can be customi2ed to provide Links to news including clinical research updates, e-journals, to self administered patient records (SA.pI~s) created by the patient at the office, 14 patient-physician communications, medical resources, links to on~-line search engines, sinks to university arid other medical library catalogues, websites with RA content, news sources, disease indexes and factual information, books and shopping, relaxed goads and services such as vendor catalogs and other services. Information relating to RA. ac9uired from these links and sources can be stored in the registry 56_ 15 SAPRs created by paxients are stared in the reg;str;,~ 56 and. constitute patient-derived data. Patients cFSn annotate their SAfRs with visit details so that an electronic record can be self maintained. SA>?R.s cart be shared with .family doctors and specialists by assigning them read-only access to portions ofthe SApks.
Through completion of the SAPRs, health and other questionnaires and 2U websiie lin>;s, the registry 56 stores patient-derived data that includes detttagraphic information, pharmaceutical product use infarmattor~, psychological counselling iritbrmation, assisted living device use information, medics! device use information, pharmaceutical product side effect information, duality of life infarrnatian, health caxe utilisation information, health care education material use information and work place disability 35 information. This information is entered into the disease management registry only after a diagnosis of RA is confirmed with the patient's physician. Information in the disease management registry cats be sold to an entity studying and/or anal.y2in~
disease management data for consideration in the form of a monetary fee_ As will be appreciated, the disease mattagetnent subsystem 14 provides a 30 convenient portal for information relating to R~. through which p~adents, healthcare practitioners and allied health professionals, researchers, industry;, academia atad government can communicate on several levels. The disease management sulbsysterrt 14 provides a single point of access for patients to learn and participate ixt research.
._ _ -..----__. ~~. _-02-23-O1 05:56pm From-SIM MCBURNEY 4165951163 T-T53 P.1B/39 F-741 The disease management subsystem 14 also allows paEients, consurxtex~s, researchers and physicians to access web pages with links to health questionnaires, infarmanori, news and other relevant products and services. This enables patients to be able to comparison-shop for a wide variety of goods and professional services, ranging from assistive devices to home renovators.
The disease surveillance subsystem 15 is designed to provide patients with RA
practical information about matxaging and living with their disease, a Comn3unity to interact with other members, practical life-aid products, and other resources on tha Internet. The disease surveillance subsystem is also designed to provide physic:iaais tools for managing patient information, graph longitudinal trends, track disease management progress and o~Tooi'aqes.
To populate the database of the disease surveihance subsystem 16; data from the government health care database is used that relates to RA. This information is obtained by looking for data that includes the appropriate physician diagnostic codes used for billing.
data an all patients who visited a physician where the billing entry included att RA
diagnostic c4de is obtained. The frequency of the diagnostic code, the speciality code ofthe physician providing the diagnoses and the use of specific medicatiansis be taken into consideration to decide which patients are included in the database. The data includes visits to healthcare professionals, bospital visits, interve#tions, anedicafiian used, axtd laboratory 24 teStS Ordered.
After the initial population of the database, incidents of RA are id~ntihed at regular time intervals (every year). The same methodology described above is used to upate the database.
As part of the validation,, the medical and laboratory records 4f a sub-sa;nple of patients are reviewed to validate the diagnosis of R.A. The provpcsed diagnostic validation exercise is necessary. Irt order to measure sensitivity and specificity of diagnosis using the proposed approach, a sample afpatients who have not been diagtuosed with RA, but who have related symptoms are required. This provides a measure of the frequency Qf false negatives yetld~ng a population-based database that is not selection biased.
34 The disease surveillance subsystem enables researa;.hers to ask specific research questions concerning RA, which can be answered at a population level.
As a result, the disease surveillance subsystem registry is a resource for individual research projects. For example, the disease surveillance subsystem will enable research ttr be conducted in:
D2-23-D1 D5:5Tpm From-SIM MCBURNEY 4165951163 T-T53 P.19/39 F-T41 _ 1d _ the evaluation of the impact of different treatment strategies ari patients' quality of life and healthcare resource utilisation;
collected;
utilisatiol7;
the evaluation of the cost-effectiveness of new inte:rventioxls;
the study of the demagr~aphics o f RA within the region where data is being the compilation of population data on outcome of IE~A nn healihcare resource the performance of health services xesearch;
the evaluation of the impact of healthcare policies;
the evaluation nfihe impact of socio-demographic factors an outcome of .l~A;
setting;
based setting;
the assessment of the timeliness of clinical irtte~rventions in a population-based the assessment of access to appropriate, state-of the art care ixa a population-i~ the description of the patterns of disease severity of RA in a population-based setting; and the description of the patterns of access / referral t~o specialists such as rheumatolagists in a population-based setting.
Since the database of the disease surveillance subsystem. is population-based, ?0 it provides a global picture of the health status of people with RA,, thereby informing stakeholders on hlaw to improve this condition and providing a wol to measure the impact and outcome of interventions and policies. 'The database provides unique, current and gQpulation-based iztformation. Research conducted. using data from the disease surveillance subsystem is used to provide recommendations to healihcare professiozlals about optimal 25 treattnem strategies, by detetzttining the healthcare seeds of individuals with the condition of izlterest, and by providing informatipu that can be used by advoc;3tes to influence healihcare policies. Furthermore, data fmm the disease surveillance subsysl:em allows an estimate of the real cost of R.A at the population level to be made. The data cats also be used to reduce costs through post-etlective treatment and healthcare policy recommen~datians.
30 Although the system 10 as described above make<.~ particular reference to facilitating reGruittnent far Clinical trials and disease managemerJt and survelliance relating to RA., it will be appreaciated that the system is equally applicable to other diseases andlar conditions or interest.
02-23-01 05:57pm From-SIM MCBURNEY 4165951163 T-753 P.20/39 F-741 _ 17-Although a preferred exXibodiment of the present invention has been t3eseribed, those of skill in the art will appreciate that vaxiatio~s and modifications may >ae made without departing Clam the spiz~t and scope thereof as dehtled by the appended claims.
Alrl.lL! IFOj~ ~.[S~~A~SF 1V,L.~1VA(~FMFNT_g~~ $>[3~tY~1(.1_IANCE
The present invention relates to a system and method of faeilitatiug the determination of candidates eligible for a clinical trial. The presewt invention also relates to a system and method for disease management and surveillance.
Clinical trials ate one ofthe final stages in lung processes aimed at improved disease therapy. Each clinical trial is designed to answer specific scientific qaestzans and so it is impartanrthat the candidates participating in the clinical trial reflect the target 1 t1 population. Preferably, each clinical trial 1S randomized tc~ reduce bias and increase the ability to generalise the results. There are different types of clinical trials (i.e. treatment trials, prevention trials, screening iz'ials and quality of life trials) arid different phase$ of clinical trials (i.e. Phase 1 (safety), Phase II (safety and efficacy), F~hase ~ (efl:aeacy and comparison) and phase 1V (post-approval marlCettug). As such, di#~erent types of candidates 15 are needed for the different types arid phases of clinical trials.
Studies are done an candidates who either volunteer or are paid to rake part in a clinical trial to determine t>ae suitability ofthe candidates far the clinical trial. The screening of candidates that are potential subjects is a curnbersotnet and time-consuming process, Rapid as:crual Qf candidates into clinical trials requires extraordinary access to patients and patient data. Access to patients and their data has in tlhe past been limited. Tpis of course has presented difficulties enrolling the necessary number of suitable candidates for clinical trials. The end result has simply lengthened the time required to complete cliztical trials. Tnis of course translates directly into an increase in the time to first patient metric for patients in the clinical trials.
25 In an attempt to alleviate this problem, commercial and non-profit enterprises have been established to assist in the recruitment of patients for clinical trials. For example, the Canadian HIV Trials Network is a non-profit Canadian organixatian dedicated to supporting clinical trials involving people with HIVIAiDs_ The ~auadian HIV
Trials Network maintains a database that lists national clinical trials- The database is accessible to 30 individuals on line.
The National Cancer Insrituie's Physician Data Querry (PDf~l) is a non-profit American organi2ation dedicated to supporting clinical trials itrvoYving people with cancer.
P~(2 maintains a database that provides a comprehensive list of clinical trials being inducted in the United States.
02-23-01 05:51pm From-SIM MCBURNEY 4185951163 T-Z53 P.05/39 F-T41 Commercial enterprises that have been established to assist in the recruitment of patiet7ts for clinical trials include general clinical trial management and ruarketing companies, on-lute clinical trial service sites axed on-line general ntedicai information sites.
Examples of general clinical trial management and marketing companies include ~uintilcs, Rheumatology Research International and Healthcare Communicanions Group.
The nn-line clinical trial service sites are primarily fiacused on clinical trials and generate revenues from drug development compatues for on-line marketing and recruitment. Examples of these on-line clinical trial service sites include Centerwatch, The Health Exchange and Medistudy.
The online general medical infr~rmatiart sites pffer listings atldlor active recruttraent ofpatients for clizucal trials. Examples of these on-lye general medical information sites include DrKoop and AmericasDactor.
In addition to the above-described enterprises, non-profit enterprises have also been established to register patient data that tray be useful in detetmittiug candidate suitability far clinical trials. >rxamgles of non-profit electronic registries include the North American Rheumatoid Arthritis Consortium (1VARAC) registry, tt~e American Rheumatism Association Medical Infotmati8ri System (ARA.MIS), the National Data dank for ltlteutxlatic Diseases (NDE) and the Analysis of Medical practice and Health ~Dutcames in Rheumatoid Arthritis (AMPHORA) Study. These non-profit electronic registries corapile information collected by physicians that relates to chronic diseases and are for the most part used by acadetxlic researchers.
to addition to the above nQn groi;it electronic registries, other electronic registries exist. For example, the Mayo Lung Cancer Specimen Registry is an investigational cancer registry that aol leas tissue samples and patient data for research and investigative purposes. The inforttaation and biological samples in the electronic registry are explicitly linked to development of the clinical trial process. The registry lisla Mayo-sponsored clinical trials and forms the foundation for current and future clinical trials for lung cancer performed by Mayo ~l.inic investigators.
Companies that collect biological samples and disease inforruation on a commercial basis to build ethnic population databases fox gene discovery, phaxmacogenomies artdlt~r therapeutic delivery based on genetic profile also exist. Examples of such camparfies include deCUhl? Genetics, Newfound Genomics, Myriad Genetics and Galileo Gerlomics;
and Framingham Cenotnics Medicix4e loc.
02-23-O1 05:51pm From-SIM MGBURNEY 4165951163 T-Z53 P.06/39 F-Z41 _3_ The databases associated with deGfJl~E .genetics, hfewfound Genomics, and Framingham Genamics Medicine inc. compile information on individuals, whether healthy ar diseased, of a spet:ifia ethnic or geogr2~pliical group and are not necessarily disease-based.
This approach is less amenable t4 use for clinical trials that depend on perfrarming trials in diseased individuals.
Myriad Genetics maintains a proprietary database for product discovery purposes axtd leverages its access to population-based databases to~ become a fully ~tegrated biopharmaceutical company involved irt gene discovery, drug target identificarion, drag development and phannacogenomic product development_ Although enterprises to assist it1 the secruittuent of candidates fox clit7.ical trials and to maintain elecirouic registries exist, these enterprises have trot increased the speed by which suitable candidates for clinical trials are enrolled to the extent desired. Thus, a need exists far irnpxovements in the manner by which potential candidates for clinical trials are deteramined.
There is also a need to evaluate the cost-effectivecte~ss of uew and old drugs, technologies and service to improve the quaiiry of care as well as health care policies at a lower cost than carxently exists. In order to achieve this, population-based data is very important to provide the desired accurate giobal picture. Although registries including population-based data axe available, problems exist in that the registries tend to have a ?0 selection bias_ While treatment and early prevention are itt3poitant, prevention of disease has the greatest patentiai to reduce the burden. As a result, there exists a raved for a disease management system that fosters the creation of a link between patients, clinicians, researchers and indu5try_ It is therefore an object of the present invention to provide a novel system and method of facilitating the determination of candidates eligible far :a clinical trial. It is also an object of the present invention to pmvide a navel system and method for disease management and surveillance.
9ummsrv Cff'ffee Invel According to one aspect of the pxesent invention there is provided a method of facilitating the determination of candidates eligible for a clinical trial comprising the steps of:
maintaining an electronic patient registry including patient information relating to a plurality of individuals; and 02-23-D1 05:52pm From-SIM MCBURNEY 4165951183 T-Z53 P.D7/39 F-141 _q._ when individuals are needed for a clinical trial, sea:cching the patient registry based on c~teria established far said clinical trial to determine potential candidates within said patient registry that ate eligible for said. clinical trial_ Preferably, the method fi,u~ther includes contacting the potential candidates to determine if the potential candidates wish to participate in the clinical trial. Consideration is obtained from the entity for conducting the search. The consideration in the preferred embodiment is a monetary fee-Preferably, the method ftuther includes the step of:maintainiug a clinical txial registry to receive ct-iteria for clinical trials from a plurality of entiaies wishing to conduct lfl clinical trials. It is also preferred that the method further includes maintaining a disease management re~~istty to store clinical development and pharrz~aceutical product information relating to clinical trials that have been cønductsd as well as disease surveillance data. The clinical development and pharmaceutical product information can be used by entities to generate pharmacoeconomi.e data and the disease swveillance data can be used to increase the IS efficiency oftherapeutie delivery toQls-According to arrQther aspect of the present inventiv~n there is provided a method for disease management comprising the steps of maintaining a database populated with patient-derived data relating to a canditian of interest, said patient-derived data being acquired fronn a pluraIiry of difference 2d sources; and providing said patient-derived data to as entity for study andlor analyxation.
The present invention provides advantages ixt that :since patient data entered into the electronic patient registry is automatically examined to de:tercnine if the patient data fits the inclusion and exclusion criteria of a clinical trial in the clitucal trial registry, eligible 25 candidates for clinical trials can be determined guickly and efficiently.
This of course allows candidates to be enrolled in clinical trials faster thereby significantly reducing the overall time taken to rcc:ruit far clinical trials. Clinical trials can be completed more quickly thereby reducing the tithe to fast patient metric far patients in the clinical trials.
Also, since patients can opt to participate in clinical trials on line, a comprehensive electronic patient registry is 30 maintained. This allows the search for candidates to be focussed, which speeds up the tecrwitment prbcess and reduces costs.
The present invention also provides advantages in that since the patient data in the electronic patient registry can be lin3ced to a biological sample registry, a comprehensive source of biological data for pharmacogenomic studies can be maintained.
02-23-01 05:52p~ From-SIM MCBORNEY 4165951163 T-T53 P.OB/39 F-T41 Brief ()eccrjg~io~0'~'~~P L?ra~ngs An erabadiznent of the present invention will now lbe described more fully with reference to the accompanying drawings in which:
Figure 1 is a schematic diagram of a system for facilitating clinical trial recruitment and disease martagetnent and surveillance;
Figure ? is a schetatatic diagram of a clinical trial srtbsystem and a disease Managetrtent subsystem forming part of the system of Figure 1;
Figures 3a tQ 3e are profile web pages completed by the system admnaistratbr 1Q in order to register a new physicianlinvestigator, sponsor and centre in the system csf Figure t;
Figure ~ is a block flaw diagram of information available to a sponsor accessing the system ofFigure 1 via an an-line ,lnternet cannectia;n;
Figure Sa is a query web page showing the inclusion and ~xchzsia~l ctiteria established for a query of an electronic patient registry;
Figure ~b is a web page showing the results of a query of the electrønic patient registiy~
Figure 6 is a block flow diagFam of information av.ailabie to a physicianlinvcstigator accessing the system Qf Figure 1 via an ox~-ltne Internet cann~tion;
Figures 7a to 7c show a clinical trial web page questionnaire completed by a gatient prior to partictpaiiug In a clinical trial; and Figure 8 is a block slow diagram of information available to a patiextt accessing the system of Figure 1. via an on-line Internet eonnectio:n.
Ailed Descrilrtian Of The Psefefred'~~~Lll ent The prese~rit invention relates to a Method and system for facilitating clinical trial recruitment and for disease management and surveillance relating to a particular condition of interest. The system maintains an electronic patient registry in which patient data associated with cansetuing patients that is received from physicians is stored_ The patient data stored in the electronic gatiextt registry can be searched against inclusion and exclusion criteria established by sponsors interested is sponsoring clinical trials to determine patients who fit the criteria. 'T'he system also maintains a database; that stores data relating to centres associated with the condition of interest, physicianslizmest;igators within the centres who conduct the clinical trials relating to the condition of interest and sponsors who sponsor 02-23-01 05:52pm From-SIM MCBURNEY 4165951163 T-753 P.D9/39 F-T41 clinical trials. Further specifics of the system will ww be described with reference to Figures ltoS.
Turning now to Figure 1, the system for facilitating clinical trial recruitrrlent and for disease managemexu and surveillance relating iv a particular condition of interest in accordance with the present invenrion is shown and is generally identified by reference numeral 14. In this particular embodiment, the system 14 facilitates clinical trial recruitment and disease management and surveillance relating to ltlteumatQtd Arthritis (RA). Th4se of skill in the art will however appreciate that the system 14 may be .set up to facilitate clinical trial recruitment and disease management and surveillance relatin~~ to basically any disease of interest.
As can be seen, system 10 includes a clinical trial subsystem 12, a disease management subsystem 14 and a disease surveillance subsystem lb. The clinical trial subsystem 12 commt~,nicates with a biological sample registry 2fl over a communications link. The elirxical trial subsystem 12 and the disease management subsystem 14 also communicate with clinical uial centre$ 22, clinical trial spp~ors 24, physicianslinvgators 26 and patients 2$ over communications networks. pisease surveillance system 16 receives-information from a government health database 18 and from patients 28.
The clinical trial subsystem 12 and the disease marnagement subsystem 14 are based on the Adaapt software platform created by FtrtpatheQn Inc. of California. This software platform integrates data &otn multiple and far reaching data sources, analyzes and toms the data into meaningful infon-tlatiott and personalizes the delivery of the meaningful information to users based on predefined user preferences. The Adaapt software platform provides built-in mufti-level security for information. This security includes transport-level security to encrypt tlae secure sQCket layer of the HTTP protocol during communications between web servers and client coxtlputer systems. A frewall is used to isolate database and file servers from the Internet. User-access protection by assigning; user ~
numbers and passwords and data level protectir~n by encrypting data with the system are also impler~nented.
Figure ~ better illetstxates the clinical trial subsystert~ 12 and the disease management subsystem.l4. As can be seen, clinical trial subsystem 12 includes a web server 30 and a fxx server 32, both ofwhich are coxtnected to database and file servers 34. Database and ale servers 34 manage an electronic patient registry 36 storing physician-derived patient data associated with patients 2s who suffer from kA_ ><n order for a physiciatx to add a patient to the electronic patient registry, the patient must first provide the physician 26 with informed 02-23-O1 05:53pm From-SIM MCBURNEY 4165951163 T-T53 P.10/39 F-Z41 consent. Qnce informed consent has been given, the physician cant enter physician,derived data associated with the patient into the electronic patient registry 36 through the completion of questionaires. The informed consent also allows the patient daa~a to be used to identify the patient's eligibility for a clinical trial. Each patient ZS whose patient dais is stored in the electronic patient rebistry 36 is assigned a unique patient ID number. In the present embodiment, the patient ID number uses 'patient billing numbers in link the physician-derived data with Federal and provincial health data. Unce the patient 28 has been assigned a patient 1Q numbc~; the patient can access the system 1~ an-line as will he described_ Database and file servers ~4 als4 manage a clinical trial registry 38 that stares a list of the clinical trials registered in the system 1 Q and a list of the sponsers 24 who have submitted the clinical trials. The clinical trials are submitted by staonsors who wish to use the electronic patient registry 3~ to determine potential candidates that are eligible foT the clinical finals. .teach clinical trial listed u~ the clinical trial registry 3$ is identified by title, summary, objective, trial start and end dates, enrollment start and completion date, inclusion and exclusion criteria, the investigators 26 who have agreed to conduct the clinical trial and profile infQrrnatiou identifying the sponsor 24 of the clinical trial. Each sponsor ?4 in the list is identified by sponsor 1D number, c4mpany name, lacauon and. contact particulars and status_ The clinical trial subsystem 12 allows sponsors 24 registered with the system 14 to submit clinical trials that include inclusion and exclusion criteria for candidates, to the subsystem. A manager at the clinical trial subsystem 12 stores thE' information in the clinical trial registry 38 and then uses this information to generate a query of the elecuonic patient registry 36 to determine quickly and efficiently the patients in the elecuonic patient registry who fit the criteria. The manager, in turn ztotifles the physicianslinvestigators 26 associated with the eligible patients and asks the physiciansJinvestigators 26 to conduct the clinical trial, and if yes then obtain regulatory approval for the clinical trial and contact the patients to recruit and enr41 the patients in the clinical trial.
The disease management subsystem I4 also includes a web server SO and a fax server 52, bath of which are connected to database and file sewers 54.
'fhe database and ~0 file servers S~ manage a disease management registry 56 that stores a list of the el3tttcal trial ceatres 2? and the phys;cians/investigatr~rs 26 associated with the centres who conduct clinical trials relating to RA. Each centre 22 in the list is assig~c~l a unique centse ID
number. Profile information identifying each centre 22 is also stared such as the name of the centre, location and contact particulars and status (l.c. whether the centre is active or 02-23-O1 05:53pm From-SIM MCBIIRNEY 4165951163 T-753 P.11/39 F-741 _g_ inactive). each physicianlinvestigator 26 in the list is assigned a w~ique i»vestigator ID
number. Profile infarznatio# identifying each physicianlinvestig$t:or is also stored such as the name of the investigator, location and cQUtact particulars, specialty and status (i.e. whether the centre is active or in lactive).
The disease managezrrent re,~istry 56 also stores patient-derived data and information that assists users to create policy and healthy enviromnents to lessen the burden of ~.A as well as information that helps users to choose lower risk behaviours chat will will lessen the burden ofi~. In tyis manner, the disease management: subsystem 14 can provide cost-effective clinical development aad product commercia.lisatiom information to users that 1 D fosters the creation of a link involving patients with RA, cliniciana, researchers and industry.
The patient-derived data in the. disease managemeat registry 56 and the physician-derived data in the eIecronic patient registry 36 that that relates to the same patient is linked. Thus, the disease management subsystem 14 provides patient-derived data as a product linked to pbysician-derived data when the data relates to ~e same patient.
The web servers 30 aad 50 allow patients 28, phys:icianslirtvesti~ators 36, sponsoxs ?4 arid centres 22 to access the subsystems 12 and 1~1 on-line over at1 Internet connectiorf through client corrtputer systems that execute web client applications in the farm of web browsers. As is well known, the Internet provides a backbone of high-speed data communication lines between frost computers that route data and messages using the ~'CpITi~
2U suite of protocols_ pig communications between the web servers 3U and 5U
and client computer systems, the web servers send web page source files than include Hypertext Markup language (HTML) code to the client computer systems in response to reduests generated by the web browsers. The HTML code received by the client computer systems causes the web browsers to display formatted web pages to the users of the client computer systems. This enables the users to access and interact with the subsystems 12 anal 14 through web-based graphical user interfaces.
The fag servers 32 and 52 allow infonnation received from patients 2~, physicianslinvestigators 26 and sponsors ?4, who do not have access to the Internet, to submit ixtformatian to the subsystems 12 and 14 by facsimile. Iu#ormhtion received by the fax servers 32 and 52 is scanned and conveyed to the appropriate datiibase server for storage in the appropriate revistry or database.
The biological sample registry 2d stares utzne, sen,tm and cell samples of blood and synomal fluid and surgical specimens associated with patients 28 in the electronic patient registry 36. The urine, serum and cell samples of blood and synovial fluid and D2-23-01 D5:54pm From-SIM MCBIlRNEY 4165951163 T-T53 P.12/39 F-T41 -g-surgical specimens are collected from patients 28 with theix consent. ';l'1re physician-derived data in the electronic patient registry 36 and the serum and cell samples in the biological sample reg~siry 20 that are associated with the same patient are linked thereby to er~hanee the urility and impact of the electronic patient registry 36. This is due: to the fact that the combinatio>1 of ghysician-derived patient data and biological data facilitates studies of bia-markers, genomies (the identification of disease associated genes) sad pharmacogenamics (the identification of genes associated with therapeutic outcomes).
The information stared in the registries 36 and 38 of subsystem 1~ aRd in the registry ~G of subsystem 14 is managed by a system administrator.
Physicianslinvestigators 26, sponsors 2~ and centres 2? wishing to be listed the system 10 must be registered.
Registration requires the submission of appropriate profile information referred to previously to the system administrator. This infatmation is used by the system administrator to complete and save profile forms. Figures 3a to 3e shave the profile forms completed by the system administrator in order to register a new ghysicianlinvestigatar 25, spansar 24 and eerrne 22. Physieians/investigators 26 and sponsors 24 who have registered with the system 10 axe assigned unique LD numbers and passwords that can be usexi to login into the system 10. The system administrator also has the necessary rights to acc~;ss all of the infortnatioxt in the regisuies 36 and 38 and the database 56. Thus, the system administrator can edit and delete the profiles associated with physieiatis/investigators 26, spc>nsors 24 and centres 23 that are stared in the database 56.
When a sponsor ?~ establishes an on-line Internet :session with the system 10 via their client computer system, by entering the utuform resource: locator (LTRL) of the system website into the web brawler, t#~e sponsor can Iog into the system 1U
by entering their 1~ number and password. once logged la, the spansar 24 has the option to access the 2S clinical trial subsystem 12 or the disease management subsystem 1~i as shown in Figure 4. If the sponsor 24 opts to access the clinical trial subsystem 12, the ponsar has access to clinical trial services (block 1 OU) including recruitment, cs~nsulting and tn~at~keting services [blocks 102 to 1 U5) provided by the system 12. If the sponsor ~4 selects the recruitment services 102, the sponsor is able to submit a clinical trial to the subsystem 12 for storage in the clinical trial registry 38. The sponsor 2~ is charged consideration in the firm of a monetary fee for submitting a clinical trial that results in a query of the electronic p~ltient registry 36 being trade.
louring submission of a clinical trial, the sponsor 24 cortipletes a profile far the clinical trial and classifies the clinical trial into one of three classifications, namely public, 02-23-01 05:54pm From-SIM N~BURNEY 4165951163 T-T53 P.13/39 F-741 summary and private. All physiciansli.uvestrgators 26 have acces:> to the profile of a public clinical trial. With respect to clinical trials classified as summary" only select physicianslinvestigatars have access to the profiles of these clinical trials.
Summary information concerning the clitaical trials is however available to all physicians/ittvestxgators ?6. With respect to clinical trials classified as private, only select physicianslinvesitgators have access to the profiles of these clinical trials. No information is available to non-selected physicianslinvestigators 26.
Once the sponsor 24 has subutitted a clinical trial, the manager stores the clinical trial in the registry 38 and then uses the inclusion and exclusion criteria in the 1 Q submitted clir#ical trial to perform a query of the electronic paxient registry 35. Daring the query process, the manager is presented with a query web page that exposes a search engine as shown in Figure Via. The search engine includes a number of criteria fields each with associated condition and value fields together with Boolean Iogic fields. The manager in turn enters the appropriate inforfnation into the fields and then links the fields with the appropriate 1 ~ Boolean logic to establish the itzclusion and exclusion criteria to be used during the ciuery.
The query is thsa initiated causing the search engine t4 duery the ~electror~ic patieas registry 3~ based on the established inclusion and exclusion criteria. When the query is .complete, the query results are presented to the manager on a web page as shown in figure Sb. As can be seen, the web page presents a list ofthe patients that fit the inclusion and exclusion criteria 20 and the status of the patients in the list (i.e. whether they have a~ned to participate in clinical trials).
Once the daery has been completed, the manager contacts them of ghysicianslinvestigators '?5 associated with the patients identified in the query to notify them of their patients that match inclusion and exclusion criteria for a clinical trial. The manager ?S asks the physicianslinvestigators 26 to agree t4 corrdttct the clinical trial, obtain regulatory approval to conduct the clinical trial and them enrol their patients in the cliztical tri$1.
In addition to the clinical trial services 100, the spa~nsor 24 cax~ view a list of their clinical trials stored izmhe clinical trial registry 38 (black l4fi).
The sponsor also has access to additional resources tblocic 110) as well as access to the profiles :~.ssociated with 30 their clinical trials stored in the clinical trial t~egist~y 38 (block l la)_ Information concerning the patients enrolled in the sponsor's clinical trial is also available. lfxhe sponsor wishes disease management data associated with these patients, the sponsor can pay a fee for this information.
D2-23-01 D5:54pm Frum-SIM MCBURNEY 4165951163 T-153 P.14/39 F-T41 if the sponsor 24 accesses the disease n~taxxagement subsystem 14, the spattsor has access to the list of centzes 22 and the list Qf the physicianslinvestigators '26 that are stored in ttte database 56 (blocks 114 and 116). The sponsor als4 ttas acce$s to recextt news relating, to 1zA that has been posted to the subsystem 14.
S When a physicianlttivestigator ?fl lags into the system 13, the physiciatylixlvestigatar is presented with a home page chat displays news and infortraation, new publications, reminders aztd messages to the physicianlinvesti,~ator 26. From the home page, the physicianlinvestigats~r 26 can navigate either to the clinical trial subsystem 12 or to the disease management system I4 as shown in Figure b- ~f the physiicianlinvestig~tar 26 r~pts tb 1U access the clinical trial subsystem 12, the physicianlinvestigatorhas access tc~ clinical txial services (blociG 200) that include recruitrneixt, consulting and marketing services (blocks 24?
to 206).
When the physicianlinvestigator ?~ is notified by the manager of their patients who fit the inclusion and exclusion criteria of clinical trials, if the 15 physiciauunvestigatox 26 is interested in conducting the clinical tidal and enrolling their patients, the physicianlinvestigator 26 must obtain regulatory approval for the clinical trial by submitting the appropriate forms, dealing with ethics, and executing the appropriate clinical trial agreements. Clzlce the physician/ittvestigator 25 has completed 113e regulatory requirements, the system. administrator adds the physicianlinvesti;~ator to the list in the 20 registry 56 for the clinical trial and euable$ the physician/investig~ator to enroll patients for the clinical trial.
In addition, the physicianlinvestigator 26 can view a list of the clinical trials stored in the clinical trial registry 38 (blocl~ 208). Through the clinical trial registry, the physicianlinvestigator can view the profiles of clinical trials designated as public and elittical ZS trials designated as summary and private for whom the physieian/investagator 26 has been selected (block 21 l))- Also, the physicianlinvestigator 26 can enter patient data fQr a uew patient wishing to participate in a clinical trial. The patient data is stored in the electronic patient registry 36. This is achieved by completing and $ubxrritting the appropriate form as shown in Figures 7a to 7e. As can be seen, the farm includes questions regarding what drugs 30 the patient is Qn, when they were started and stopped, and why they were stopped. These three questions plus erythrocyte sedimentation rotes, answers to the health assesment questionaire (HAQ) and azatiual X-rays enables the patient data in the electronic patient registry 36 to be used in conjunction with biological samples story.-d in the biological sample registry 24 fQr pharmacogenomtcs purposes. When patient data for the new patient coshing 02-23-01 05:55pm From-SIM MCBURNEY 4165951163 T-753 P.15/39 F-741 _I2_ to participate in a clinical trial is entered into the electronic patient registry 34, a query ofthc electronic patient registry can be made to detenrzzine if the patient data Fts the inclusion and exclusion criteria associated with any of the clinical trials in the c:~inical trial registry 38.
The physicianlinvestigator ?6 can also access information relating to the clinical trials in which the physicianlixtvestigator is currently pat~ticipaiing (block 214). This information includes general information about the clinical trial, the regulatory status of the clinical trial, a list of all the patients that the physicianlinvestigatox 26 has enrolled itt the clinical trial as well as a spy of the cumber of patients enrolled in the clinical trial by all other physicianslinvestigators.
1 p If the physicianlinvestigator 26 accesses the disuse uraxtagement subsystem 1 d, the physiciaminvestigacor has access to the list of centres 22 arid the list of investigators that are stoned in the registry 56 (blocks 220 and 222). ~'he physicianlinvestigator 2b also has access to recent news relating to R.A. that has been posted to the subsystem 14 (block 224). In ar~ditiop., the physicianlinvestigator can access a list of the physiei.anlirzvestigator's patients who are participating in clinical trials (block 2?6) but does not have access to dat$ from any other physician's patients- From the list, the investigator can see which clinical trials each patient is parcicipatizig in and car; access each patient's prbfile. The physicianlinvestigator can also access a search engine similar to that shown in Figure Sa and conduct querns ofthe patient data in the electronic patient registry 3b that is associated with the physicianlinvestigator's patients. 'flze patient's profile provides coptact information allowing the physzcianlinvestigatar to contact the patient directly (block 22$). Access to the patient's profile also allows the physician/invesrigator to update the patieril: data in the electronic patient registry 3s (block ?30).
The disease management subsystem 14 also provides an ethics area and a messaging area. The ethics area presents information relating to ethics committees, whether ethics memberships have been submitted to the system 10, the frequency of ethics meetings and the frequency of submissions far new proposals. The messagixzg area allows the plzysicianlirivestigator to send secure messages to the systwn administrator and to sponsors 2~4.
When a patient 28 accesses the system 10, the patient has the option to access the clinical trial subsystQm 12 or the disease management subsystem 14 as shown in Figure $.
if the patient opts to access the clinical trial subsystem 12, the patient can vices the list of clinical trials in the clinical trial registry 38 (block 300) and can elect to participate in a clinical trial by selecting a clinical trial from the list and completing and submitting a 02-23-O1 05:55pm From-SIM MCBURNEY 4165951163 T-T53 P.16/39 F-741 recruitment farm (block 302)- This changes the patient's status in the clectmnic patient registry 36 to active. The patient 28 can also access iufartttation c:onceming available clinical trials including a list of the centres 22 conducting clinical trials (block 304) and frequently asked guestions (block 306).
If the patient 28 opts to access the disease mattagecxtent subsystem 14, the patient can view thecr patient data that is scored in the electronic patient registry 36 (block 310) and. their physician's contact information to allow the patient to cQrttact their physician directly (block 313). The patient can also access the list of the ce:atres in the database Sb (block 314) and the list of physicianslinvestigators ?6 in the database 56 tbiock 3 3 b).
The system administrator moaitors the system 10 tutd generates reports on a regular basis for the sponsors 24 of clitucal trials. For each clinical trial, a report is generated that includes an update on the physicianslinvestigators regulatory status and the patient enrolment by each physielanlinvestigator fox the clinical uial.
As will he appreciated, the clinical trial subsystem 12 facilitates the I ~ recruitment of candidates for clinical trials thereby speeding up the recruitment time. This is due to the fact that patients can access the clinical trial subsystem 12 oa-liae and elect to participate in clinical trials. Patient data entered into the electroniic patiexlt registry is compared with the inclusion and exclusion criteria of clinical tria:~s allowing eligible candidates for the clinical trials to be d~termtned quickly and efficiently and them contacted to enrol in the clinical trials.
Although the ciitiical trial subsystem 12 is described as using a manager to populate rite clinical trial registry 3$, conduct the electronic patient registry query and botify physicianshnvestigators 20 if their patients ft the criteria of cliuic:al trials, those of skill in the art will appreciate that this process can be automated. In this wa5r, clinical trials can be submitted electronically to the clinical trial subsystem 1~ for stor,~ge in the clinical trial registry 38. fence in the clinical trial registry, the inclusive and exclusive criteria can be retrieved automatically and used during an electronic patient regi;suy query.
Physicianslinvestigatflrs whose patients fit the criteria can then be:
notified electronically.
Satellite terminals are installed at the offices and clinics of physicians/investigators 26 and execute web client applications such as web browsers. When a patient visits a physicianlinvestigator for an appointment, the patient is asked to access a health questionnaire (block 318) through the disease managemeztt system 14 and answer the questionnaire. Tlte information entered by the patient is incorporated into the database at the df~ce or clinic and is compared with prior data to generate a historical summary based on the 02-23-01 05:56pm From-SIM MCBURNEY 4165951163 T-153 P.iT/39 F-141 physician's preferences (i_e. medications, HALE score, pain scale,,joint count over time etc.).
The results of the comparison are presented to the physician in graphical format prior to the physician's meeting with the patient. This conserves tune fax the physician and the patient and provides the physician with a database tool that cart be used u~ better manage patient workload. Tile information is also transmitted to the system for storage in the registry 56.
The web >?rowser executed lay each satellite tetrriirial provides a bast of other useful Bilks that are customisable by the physicianlinvestigator. For example, the web client application can be customi2ed to provide Links to news including clinical research updates, e-journals, to self administered patient records (SA.pI~s) created by the patient at the office, 14 patient-physician communications, medical resources, links to on~-line search engines, sinks to university arid other medical library catalogues, websites with RA content, news sources, disease indexes and factual information, books and shopping, relaxed goads and services such as vendor catalogs and other services. Information relating to RA. ac9uired from these links and sources can be stored in the registry 56_ 15 SAPRs created by paxients are stared in the reg;str;,~ 56 and. constitute patient-derived data. Patients cFSn annotate their SAfRs with visit details so that an electronic record can be self maintained. SA>?R.s cart be shared with .family doctors and specialists by assigning them read-only access to portions ofthe SApks.
Through completion of the SAPRs, health and other questionnaires and 2U websiie lin>;s, the registry 56 stores patient-derived data that includes detttagraphic information, pharmaceutical product use infarmattor~, psychological counselling iritbrmation, assisted living device use information, medics! device use information, pharmaceutical product side effect information, duality of life infarrnatian, health caxe utilisation information, health care education material use information and work place disability 35 information. This information is entered into the disease management registry only after a diagnosis of RA is confirmed with the patient's physician. Information in the disease management registry cats be sold to an entity studying and/or anal.y2in~
disease management data for consideration in the form of a monetary fee_ As will be appreciated, the disease mattagetnent subsystem 14 provides a 30 convenient portal for information relating to R~. through which p~adents, healthcare practitioners and allied health professionals, researchers, industry;, academia atad government can communicate on several levels. The disease management sulbsysterrt 14 provides a single point of access for patients to learn and participate ixt research.
._ _ -..----__. ~~. _-02-23-O1 05:56pm From-SIM MCBURNEY 4165951163 T-T53 P.1B/39 F-741 The disease management subsystem 14 also allows paEients, consurxtex~s, researchers and physicians to access web pages with links to health questionnaires, infarmanori, news and other relevant products and services. This enables patients to be able to comparison-shop for a wide variety of goods and professional services, ranging from assistive devices to home renovators.
The disease surveillance subsystem 15 is designed to provide patients with RA
practical information about matxaging and living with their disease, a Comn3unity to interact with other members, practical life-aid products, and other resources on tha Internet. The disease surveillance subsystem is also designed to provide physic:iaais tools for managing patient information, graph longitudinal trends, track disease management progress and o~Tooi'aqes.
To populate the database of the disease surveihance subsystem 16; data from the government health care database is used that relates to RA. This information is obtained by looking for data that includes the appropriate physician diagnostic codes used for billing.
data an all patients who visited a physician where the billing entry included att RA
diagnostic c4de is obtained. The frequency of the diagnostic code, the speciality code ofthe physician providing the diagnoses and the use of specific medicatiansis be taken into consideration to decide which patients are included in the database. The data includes visits to healthcare professionals, bospital visits, interve#tions, anedicafiian used, axtd laboratory 24 teStS Ordered.
After the initial population of the database, incidents of RA are id~ntihed at regular time intervals (every year). The same methodology described above is used to upate the database.
As part of the validation,, the medical and laboratory records 4f a sub-sa;nple of patients are reviewed to validate the diagnosis of R.A. The provpcsed diagnostic validation exercise is necessary. Irt order to measure sensitivity and specificity of diagnosis using the proposed approach, a sample afpatients who have not been diagtuosed with RA, but who have related symptoms are required. This provides a measure of the frequency Qf false negatives yetld~ng a population-based database that is not selection biased.
34 The disease surveillance subsystem enables researa;.hers to ask specific research questions concerning RA, which can be answered at a population level.
As a result, the disease surveillance subsystem registry is a resource for individual research projects. For example, the disease surveillance subsystem will enable research ttr be conducted in:
D2-23-D1 D5:5Tpm From-SIM MCBURNEY 4165951163 T-T53 P.19/39 F-T41 _ 1d _ the evaluation of the impact of different treatment strategies ari patients' quality of life and healthcare resource utilisation;
collected;
utilisatiol7;
the evaluation of the cost-effectiveness of new inte:rventioxls;
the study of the demagr~aphics o f RA within the region where data is being the compilation of population data on outcome of IE~A nn healihcare resource the performance of health services xesearch;
the evaluation of the impact of healthcare policies;
the evaluation nfihe impact of socio-demographic factors an outcome of .l~A;
setting;
based setting;
the assessment of the timeliness of clinical irtte~rventions in a population-based the assessment of access to appropriate, state-of the art care ixa a population-i~ the description of the patterns of disease severity of RA in a population-based setting; and the description of the patterns of access / referral t~o specialists such as rheumatolagists in a population-based setting.
Since the database of the disease surveillance subsystem. is population-based, ?0 it provides a global picture of the health status of people with RA,, thereby informing stakeholders on hlaw to improve this condition and providing a wol to measure the impact and outcome of interventions and policies. 'The database provides unique, current and gQpulation-based iztformation. Research conducted. using data from the disease surveillance subsystem is used to provide recommendations to healihcare professiozlals about optimal 25 treattnem strategies, by detetzttining the healthcare seeds of individuals with the condition of izlterest, and by providing informatipu that can be used by advoc;3tes to influence healihcare policies. Furthermore, data fmm the disease surveillance subsysl:em allows an estimate of the real cost of R.A at the population level to be made. The data cats also be used to reduce costs through post-etlective treatment and healthcare policy recommen~datians.
30 Although the system 10 as described above make<.~ particular reference to facilitating reGruittnent far Clinical trials and disease managemerJt and survelliance relating to RA., it will be appreaciated that the system is equally applicable to other diseases andlar conditions or interest.
02-23-01 05:57pm From-SIM MCBURNEY 4165951163 T-753 P.20/39 F-741 _ 17-Although a preferred exXibodiment of the present invention has been t3eseribed, those of skill in the art will appreciate that vaxiatio~s and modifications may >ae made without departing Clam the spiz~t and scope thereof as dehtled by the appended claims.
Claims (18)
1. A method of facilitating the determination of candidates eligible for a clinical trial comprising the steps of:
maintaining an electronic patient registry including patient data relating to a plurality of individuals; and when individuals are needed for a clinical trial, searching the patient registry based on criteria established for said clinical trial to determine potential candidates within said patient registry that are eligible for said clinical trial.
maintaining an electronic patient registry including patient data relating to a plurality of individuals; and when individuals are needed for a clinical trial, searching the patient registry based on criteria established for said clinical trial to determine potential candidates within said patient registry that are eligible for said clinical trial.
2. The method of claim 1 further comprising the step of contacting the potential candidates to determine if said potential candidates wish to participate in said clinical trial.
3. The method of claim 2 further comprising the step of obtaining consideration from said entity for conducting said search.
4. The method of claim 3 wherein said consideration is a monetary fee.
5. The method of claim 3 further comprising the step of maintaining a clinical trial registry, said clinical trial registry receiving criteria for clinical trials from a plurality of entities wishing to conduct clinical trials, the criteria for said clinical trials being used during said searching step.
6. The method of claim 5 wherein said searching step is automatically re-performed when patient data in said patient registry is modified.
7. The method of claim 3 wherein the patient information is received from physicians.
8. The method of claim 7 wherein individuals can elect to opt to participate in clinical trials on line.
9, The method of claim 2 wherein the step of contacting the potential candidates includes the steps of contacting each individual's physician and asking the physicians to contact the eligible candidates.
10. The method of claim 2 further comprising the step of maintaining a disease management registry said disease management registry staring patient-derived data acquired from multiple sources.
11. The method of claim 10 wherein said patient-derived information is selected from the the group consisting of demographic information; pharmaceutical product use information; psychological counselling information; assisted living device use information;
medical device use information; pharmaceutical product side effect information; quality of life information; health care utilisation information; health care education material use information; and work place disability information.
medical device use information; pharmaceutical product side effect information; quality of life information; health care utilisation information; health care education material use information; and work place disability information.
12. The method of claim 10 further comprising the steps of maintaining a disease surveillance registry.
13. The method of claim 10 wherein said clinical development and pharmaceutical product information is used by entities to generate pharmacoeconomic data developed in conjunction with generic information derived from patient biological samples.
14. The method of claim 12 wherein said disease surveillance data is used to increase the efficiency of the delivery of health care information and services in place of therapeutic delivery.
15. A method for disease management comprising the steps of:
maintaining a database populated with patient-derived data relating to a condition of interest, said patient-derived data being acquired from a plurality of difference sources; and providing said patient-derived data to an entity for study and/or analyzation.
maintaining a database populated with patient-derived data relating to a condition of interest, said patient-derived data being acquired from a plurality of difference sources; and providing said patient-derived data to an entity for study and/or analyzation.
16. The method of claim 14 further comprising the step of acquiring consideration for providing said patient-derived data.
17. The method of claim 15 wherein said patient-derived information is selected from the the group consisting of: demographic information; pharmaceutical product use information; psychological counselling information; assisted living device use information;
medical device use information; pharmaceutical product side effect information; quality of life information; health care utilisation information; health care educational material use information; and work place disability information.
medical device use information; pharmaceutical product side effect information; quality of life information; health care utilisation information; health care educational material use information; and work place disability information.
18. A system for facilitating the determination of candidates eligible for a clinical trial comprising:
an electronic patient registry including patient data relating to a plurality of individuals; and a search engine responsive to search criteria and searching the patient registry based on criteria established for said clinical trial to determine potential candidates within said patient registry that are eligible for said clinical trial.
an electronic patient registry including patient data relating to a plurality of individuals; and a search engine responsive to search criteria and searching the patient registry based on criteria established for said clinical trial to determine potential candidates within said patient registry that are eligible for said clinical trial.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA002337665A CA2337665A1 (en) | 2001-02-23 | 2001-02-23 | Method and system for facilitating clinical trial recruitment and for disease management and surveillance |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA002337665A CA2337665A1 (en) | 2001-02-23 | 2001-02-23 | Method and system for facilitating clinical trial recruitment and for disease management and surveillance |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2337665A1 true CA2337665A1 (en) | 2002-08-23 |
Family
ID=4168415
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002337665A Abandoned CA2337665A1 (en) | 2001-02-23 | 2001-02-23 | Method and system for facilitating clinical trial recruitment and for disease management and surveillance |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2337665A1 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005081163A3 (en) * | 2004-02-18 | 2005-12-01 | Siemens Ag | Method for the selection of a participant in a medical project with selection criteria for patients |
| WO2015166005A1 (en) * | 2014-04-30 | 2015-11-05 | Clinerion Ltd | Patient recruitment system and patient recruitment method |
-
2001
- 2001-02-23 CA CA002337665A patent/CA2337665A1/en not_active Abandoned
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2005081163A3 (en) * | 2004-02-18 | 2005-12-01 | Siemens Ag | Method for the selection of a participant in a medical project with selection criteria for patients |
| WO2015166005A1 (en) * | 2014-04-30 | 2015-11-05 | Clinerion Ltd | Patient recruitment system and patient recruitment method |
| US11915800B2 (en) | 2014-04-30 | 2024-02-27 | Clinerion Ltd | Patient recruitment system and patient recruitment method |
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