System and method for facilitating centralized candidate selection and monitoring subject participation in clinical trial studies

• US 20050038692A1
• Filed: 08/14/2003
• Published: 02/17/2005
• Est. Priority Date: 08/14/2003
• Status: Abandoned Application

• Current Assignee: MedAvante, Inc. (WCG Clinical, Inc.)
• Original Assignee: MedAvante, Inc. (WCG Clinical, Inc.)
• Inventors: Gilbert, Paul Michael, Kane, John Michael, Johnson, Livingston
• Application Number:
  US10/640,692
• Publication Number:
  US 20050038692A1
• Time in Patent Office: Days
• US Class Current: 705/10
• CPC Class Codes: G06Q 10/06393 Score-carding, benchmarking or key performance indicator [KPI] analysis
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G06Q 30/0203 Market surveys; Market polls
• CPC Class Codes: G06Q 99/00 Subject matter not provided for in other groups of this subclass
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage

Abstract

A system and method of facilitating centralized and standardized remote ratings of subjects in clinical trial studies includes providing training to raters located at one or more central rating sites such that the raters are trained to apply substantially similar criteria in determining whether a candidate is a qualified subject for the clinical trial and/or in the actual assessment, or information collection, phase of the clinical trail. By having centralized, consistently trained raters that are independent of clinical trial investigators, inter-rater reliability is enhanced and potential bias is reduced, thus increasing the effectiveness of the clinical trial results by providing more qualified subjects and more accurate results.

Claims

1. A method for facilitating centralized and standardized ratings of subjects in clinical trial studies, the method comprising:

training raters located at at least one central rater site to employ substantially similar criteria for at least one of recruiting qualified subjects and collecting information from the qualified subjects; and

interviewing the qualified subjects by the raters located at the at least one central rater site, wherein the interviewing is to accomplish the at least one of recruiting qualified subjects and collecting information from the qualified subjects.

2. The method of claim 1, wherein the raters obtain centralized informed consent from the qualified subjects.

3. The method of claim 1, wherein the at least one central rater site is at least one of remote and centralized from the subjects.

4. The method of claim 1, wherein the at least one central rater site is at least one of a similar physical location or a virtual location.

5. The method of claim 1, wherein the qualified subjects are located at at least one satellite location.

6. The method of claim 5, wherein the at least one satellite location comprises at least one of a doctor'"'"'s office, a clinic, a qualified subject'"'"'s home, a hospital, a school, an office building, a shopping mall, a house of worship, and a factory.

7. The method of claim 1, wherein the interviewing is accomplished utilizing virtual communications over a network.

8. The method of claim 7, wherein the network comprises the Internet.

9. The method of claim 7, wherein the virtual communications comprises at least one of a video and audio conference, a live on-line chat, and electronic mail.

10. The method of claim 1, wherein the step of interviewing is accomplished utilizing video-conferencing.

11. The method of claim 1, wherein the step of interviewing is accomplished utilizing at least one of audio and video telephonic means.

12. The method of claim 1, further comprising the step of forwarding the collected information to at least one investigator for analysis.

13. The method of claim 12, wherein the step of forwarding comprises the step of forwarding at least one of the collected information and an analysis of the collected information to at least one interested party.

14. The method of claim 1, further comprising the step of forwarding the collected information to at least one interested party for analysis.

15. A system for facilitating centralized and standardized ratings of subjects in clinical trial studies, the system comprising:

at least one central rater site comprising raters that are trained to employ consistent criteria for at least one of recruiting qualified subjects and collecting information from the qualified subjects; and

at least one satellite site, coupled to the at least one central rater site, at which study candidates are interviewed by the raters to determine at least one of whether the candidates are qualified subjects and to provide information to the raters.

16. The system of claim 15, wherein the at least one central rater site comprises at least one central rater site computer.

17. The system of claim 15, wherein, each of the at least one satellite site comprises at least one satellite site computer.

18. The system of claim 15, wherein the at least one central rater site is at least one of remote and centralized from the subjects.

19. The system of claim 15, wherein the at least one central rater site is at least one of a similar physical location and a virtual location.

20. The system of claim 15, wherein the raters use the at least one central rater site computer to interview the candidates at the at least one satellite site over a network, wherein the network couples the at least one satellite site to the at least one central rater site.

21. The system of claim 20, wherein the candidates receive interview questions and respond to interview questions using the at least one satellite site computer.

22. The system of claim of claim 20, wherein the network comprises at least one of the Internet, an intranet, satellite, and telephonic communication means.

23. The system of claim 21, wherein the candidates receive interview questions and respond to interview questions using video telephonic means, audio telephonic means, video conferencing, on-line chatting, and electronic mail.

24. The system of claim 22, further comprising means for connecting the at least one central rater site computer and the at least one satellite site computer to the Internet by high-speed connections.

25. The system of claim 22, further comprising means for enabling candidates at the at least one satellite site to communicate with raters at the at least one central rater site by communication between the at least one satellite site computer and the at least one central rater site computer over the network in at least one of real-time and almost real-time.

26. The system of claim 24, further comprising means for facilitating at least one of interactive streaming audio and interactive video media presentations presented through peripheral equipment of the at least one satellite site computer and the at least one central rater site computer.

27. The system of claim 15, wherein the at least one satellite site comprise at least one of a doctor'"'"'s office, a clinic, a qualified subject'"'"'s home, a hospital, a school, a factory floor, an office building, a shopping mall, and a house of worship.

28. The system of claim 15, further comprising a video-conferencing system to enable raters to interview candidates.

30. The computer-readable medium of claim 28, wherein the computer-readable medium further enables the interviewing to be accomplished utilizing communications over a network.

29. A computer-readable medium storing program code which, when executed on a computerized device, causes the computerized device to execute a method for centralized and standardized ratings of subjects in clinical trial studies, the method comprising:

training raters located at at least one central rater site to employ substantially similar criteria for at least one of recruiting qualified subjects and collecting information from the qualified subjects, wherein the at least one central rater site is at least one of a similar physical location or a virtual location; and

interviewing qualified subject by the raters located at the at least one central rater site, wherein the interviewing is to accomplish the at least one of recruiting qualified subjects and collecting information from the qualified subjects.

31. The method of claim 29, wherein the network comprises the Internet, an intranet, satellite, and telephonic communication means.

32. The method of claim 29, wherein the interviews are accomplished using at least one of video conferencing, audio conference, a live on-line chat, and electronic mail.