SYSTEM AND METHOD FOR FACILITATING CANDIDATE AND SUBJECT PARTICIPATION IN CLINICAL TRIAL STUDIES

• US 20120084100A1
• Filed: 12/06/2011
• Published: 04/05/2012
• Est. Priority Date: 02/14/2002
• Status: Abandoned Application

• Current Assignee: MedAvante, Inc. (WCG Clinical, Inc.)
• Original Assignee: MedAvante, Inc. (WCG Clinical, Inc.)
• Inventors: TILLES, Peter B., ALTER, Carol L., THOMAS, H. Mikel
• Application Number:
  US13/312,040
• Publication Number:
  US 20120084100A1
• Time in Patent Office: Days
• US Class Current: 705/3
• CPC Class Codes: G06Q 10/0637 Strategic management or analysis, e.g. setting a goal or target of an organisation; Planning actions based on goals; Analysis or evaluation of effectiveness of goals
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records

Abstract

The present invention discloses systems and methods for facilitating candidate and subject participation in clinical trial studies. Medical professionals participating in the study at satellite sites assist in recruitment of their pre-existing patients as subjects in the study. Clinical trial data collected from the subjects is communicated over a computer network from the satellite sites to core sites. Study coordination is performed at the core sites. The collected clinical trial data is analyzed in accordance with the study at an interested party site.

Claims

1. A system for facilitating candidate and subject participation in a clinical trial study, the system comprising:

one or more interested party sites at which collected clinical trial data is analyzed in accordance with the study, each of the interested party sites having one or more interested party site computers, and the collected clinical trial data being communicated to the interested party site computers over a network;

a plurality of core sites at which coordination of the clinical trial study is performed, each of the core sites having one or more core site computers; and

a plurality of satellite sites at which one or more medical professionals participating in the study assist in recruitment of one or more pre-existing patients of the medical professionals as subjects in the study from whom a first set of clinical trial data of the collected clinical trial data is collected, each of the satellite sites having one or more satellite site computers connected through the network to at least one of the core site computers, wherein the first set of clinical trial data is communicated from each of the satellite sites by one or more of the satellite site computers over the network to one or more of the core site computers.

2. The system of claim 1, wherein the medical professionals assist in identification of candidates.

3. The system of claim 1, wherein a second set of clinical trial data is collected from one or more subjects at one or more of the core sites.

4. The system of claim 1, wherein the first set of clinical trial data is collected at the satellite sites and input into the satellite site computers.

5. The system of claim 1, wherein the network comprises the Internet.

6. The system of claim 1, comprising means for coordinating and managing the study from the core sites, including means for monitoring study related activities occurring at the satellite sites.

7. The system of claim 1, comprising a clinical trial database connected to the network, and wherein all clinical trial data for the study is stored in the clinical trial database.

9. The system of claim 1, comprising means for targeting patients as candidates including means for querying a database containing information about medical histories of the patients, based on characteristics of the study.

10. The system of claim 1, comprising a historical database storing statistical data associated with the clinical trial study in one or more databases, and comprising means for utilizing the historical database in planning one or more future clinical trial studies.

11. The system of claim 10, wherein the means for utilizing the historical database comprises means for using statistical data in at least one of selecting one or more appropriate satellite sites for a future clinical trial study, selecting one or more appropriate core sites for a future clinical trial study, and selecting one or more appropriate medical professionals to participate in a future clinical trial study.

12. The system of claim 1, wherein the network comprises the Internet, and comprising means for connecting the satellite site computers and the core site computers to the Internet by high speed Internet connections of at least 100,000 bits per second, and comprising means for enabling subjects to communicate from the satellite sites with investigators at the core sites by communication between the satellite site computers and the core site computers over the Internet in real time or almost real time and comprising at least one of interactive streaming audio and interactive streaming video media presentations presented through monitors of the satellite site computers and the core site computers.

13. The system of claim 1, wherein the medical professionals comprise physicians, and wherein the physicians utilize the physicians'"'"' medical records to identify a first set of patients of the physicians who seem to be appropriately qualified participate as subjects in the study.

14. The system of claim 13, wherein the physicians recruit patients of the first set such that the patients of the first set enroll as subjects in the study.

15. The system of claim 14, wherein clinical trial data collected from the patients of the first set at the satellite sites is communicated from the satellite site computers at the satellite sites over the Internet to the core site computers at the core sites.

16. The system of claim 1, wherein each of the core sites is associated with a set of one or more of the satellite sites, and comprising means for, at each of the core sites, performing coordination of clinical trial study related activities occurring at the associated set of satellite sites.

17. The system of claim 16, comprising means for, at each of the core sites, tracking clinical trial study related activities occurring at the associated set of satellite sites to monitor compliance with protocol associated with the clinical trial study.

18. The system of claim 1, comprising means for allowing pier to pier communication between core site computers of the core site computers and satellite site computers of the satellite site computers.

8. The system of claim I, comprising means for selecting appropriate participating medical professionals for the study including means for querying a database containing information about the practices of the medical professionals, based on characteristics of the study.

19. A method for facilitating candidate and subject participation in a clinical trial study, the method comprising:

a plurality of medical professionals at a plurality of satellite sites assisting in recruitment of one or more pre-existing patients of the medical professionals as subjects in the study;

one or more of the subjects in the study participating from the satellite sites, comprising collecting a first set of clinical trial data from the subjects and communicating the first set of clinical trial data over a network from one or more satellite site computers at the satellite sites to one or more core site computers at a plurality of core sites;

performing clinical trial study coordination at the core sites; and

analyzing the first set of clinical trial in accordance with the study at one or more interested party sites, the first set of clinical trial data being communicated to one or more interested party site computers at the one or more interested party sites over the network.

20. The method of claim 19, comprising the medical professionals assisting in identification of candidates.

21. The method of claim 19, wherein a second set of clinical trial data is collected from one or more subjects at one or more of the core sites.

22. The method of claim 19, wherein the first set of clinical trial data is collected at the satellite sites and input into the satellite site computers.

23. The method of claim 19, wherein the communicating over the network comprises communicating over the Internet.

24. The method of claim 19, comprising performing management of the clinical trial study at the core sites, and comprising monitoring study related activities occurring at the satellite sites.

25. The method of claim 19, comprising storing all clinical trial data for the study in a clinical trial database connected to the network.

26. The method of claim 19, wherein appropriate participating medical professionals for the study are identified at least in part by querying of a database containing information about the practices of the medical professionals based on characteristics of the study.

27. The method of claim 19, wherein the patients are targeted as candidates at least in part by querying of a database containing information about medical histories of the patients, based on characteristics of the study.

28. The method of claim 19, comprising storing statistical data associated with the clinical trial study in one or more databases, and comprising utilizing the statistical data in planning one or more future studies.

29. The method of claim 28, wherein the statistical data is utilized in at least one of selecting one or more appropriate satellite sites for a future clinical trial study, selecting one, or more appropriate core sites for a future clinical trial study, and selecting one or more appropriate medical professionals to participate in a future clinical trial study.

30. The method of claim 19, wherein the network comprises the Internet, and wherein the satellite site computers and the core site computers are connected to the Internet by high speed Internet connections of at least 100,000 bits per second, and wherein the subjects communicate from the satellite sites with investigators at the core sites by communication between the satellite site computers and the core site computers, and wherein the communication is in real time or almost real time and comprises at least one of interactive streaming audio and interactive streaming video media presentations presented through monitors of the satellite site computers and the core site computers.

31. The method of claim 19, wherein the medical-professionals comprise physicians, and comprising the physicians utilizing the physicians'"'"' medical records to identify a first set of patients of the physicians who seem to be appropriately qualified participate as subjects in the study.

32. The method of claim 31, comprising the physicians recruiting patients of the first set such that the patients of the first set enroll as subjects in the study.

33. The method of claim 32, comprising communicating clinical trial data, collected from the patients of the first set at the satellite sites, from the satellite site computers at the satellite sites over the Internet to the core site computers at the core sites.

34. The method of claim 19, wherein each of the core sites is associated with a set of one or more of the satellite sites, and comprising performing, at each of the core sites, coordination of clinical trial related activities occurring at the associated set of satellite sites.

35. The method of claim 34, comprising, at each of the core sites, tracking clinical trial study related activities occurring at the associated set of satellite sites to monitor compliance with protocol associated with the clinical trial study.

36. The method of claim 19, comprising pier to pier communicating between core site computers of the core site computers and satellite site computers of the satellite site computers.

37. A computer usable medium storing program code which, when executed on a computerized device, causes the computerized device to execute a method for facilitating candidate and subject participation in a clinical trial study, the method comprising:

a plurality of medical professionals at a plurality of satellite sites assisting in recruitment of one or more pre-existing patients of the medical professionals as subjects in the study;

one or more of the subjects in the study participating from the satellite sites, comprising collecting a first set of clinical trial data from the subjects and communicating the first set of clinical trial data over a network from one or more satellite site computers at the satellite sites to one or more core site computers at a plurality of core sites;

performing clinical trial study coordination at the core sites; and

analyzing the first set of clinical trial in accordance with the study at one or more interested party sites, the first set of clinical trial data being communicated to one or more interested party site computers at the one or more interested party sites over the network.