Method and system for providing real-time clinical trial enrollment data

• US 20070250779A1
• Filed: 04/08/2005
• Published: 10/25/2007
• Est. Priority Date: 12/18/2001
• Status: Active Grant

• Current Assignee: Matt Wallach, Prasad Inampudi, Rachel Yang, Sathya Thulsidas, Sheela Sundaresan
• Original Assignee: Matt Wallach, Prasad Inampudi, Rachel Yang, Sathya Thulsidas, Sheela Sundaresan
• Inventors: Sundaresan, Sheela, Yang, Rachel, Thulsidas, Sathya, Wallach, Matt, Inampudi, Prasad
• Granted Patent: US 7,899,685 B2
• Time in Patent Office: Days
• US Class Current: 715/740
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: Y10S 707/99931 Database or file accessing
• CPC Class Codes: Y10S 707/99943 Generating database or data structure, e.g. via user interface
• CPC Class Codes: Y10S 707/99945 Object-oriented database structure processing

Abstract

A method and system for enabling display of real-time clinical trial enrollment data. A set of computer forms corresponding to an application enable administrative personnel to define a plurality of clinical trial parameters, including trial protocols, clinical sites, and optional regions. As the data is entered, it is stored in a central database, typically through a dedicated connection between a client running the application and the database. Software and infrastructure for supporting an Internet web portal is also provided, whereby the web portal enables clinical site personnel to enter subject enrollment data that is stored in the database as it is entered (i.e., in real-time). Various charts pertaining to the subject enrollment data may then be generated, including subject status charts and subject enrollment rate charts. In general, the charts may be aggregated across individual sites, regions, and all sites corresponding to a given protocol.

Claims

1. (canceled)

2. A computer-readable medium having stored thereon a set of instructions which when executed perform a method, comprising:

receiving, in a user interface on a client system, a user request for a display of selected data aggregated from subject enrollment data in a server system pertaining to a clinical trial; and

responsive to the user request, displaying on the client system a chart to graphically portray the selected data.

3. The medium of claim 2, wherein the user interface is displayed within a web browser on the client system.

4. The medium of claim 3, wherein the subject enrollment data is stored on a central database accessible through an Internet web portal running on the server system.

5. The medium of claim 3, wherein the selected data is aggregated at a plurality of enrollment statuses.

6. The medium of claim 5, wherein the enrollment statuses comprise at least two from a group consisting:

screened, re-screened, screen failure, enrolled, completed, and early termination.

7. The medium of claim 5, wherein the chart is to graphically portray numbers of subjects aggregated at a selected level for the plurality of enrollment statuses.

8. The medium of claim 3, wherein the selected data is aggregated to show variations over a time period.

9. The medium of claim 8, wherein the selected data is aggregated at a plurality of periodic intervals.

10. The medium of claim 9, wherein the chart is to graphically portray numbers of subjects aggregated at a selected level for the plurality of periodic intervals.

11. The medium of claim 3, wherein the selected data correspond to an individual clinical trial site that implements a clinical trial protocol for the clinical trial.

12. The medium of claim 3, wherein the selected data is aggregated across a plurality of clinical trial sites that implement a same clinical trial protocol for the clinical trial.

13. The medium of claim 3, wherein the selected data is aggregated across a plurality of clinical trial protocols for the clinical trial.

14. The medium of claim 3, wherein the selected data is aggregated at a level from a group consisting:

a clinical trial site, a clinical trial region, and a clinical trial protocol.

15. The medium of claim 3, wherein the web browser renders one or more applets to generate the user interface.

16. The medium of claim 15, wherein the one or more applets communicate with the server system using a remote procedure call (RPC) mechanism and a notification mechanism.

17. The medium of claim 15, wherein the one or more applets are java-script based.

18. A method, comprising:

receiving, in a user interface on a client system, a user request for a display of selected data aggregated from subject enrollment data in a server system pertaining to a clinical trial; and

responsive to the user request, displaying on the client system a chart to graphically portray the selected data.

19. The method of claim 18, wherein the user interface comprises one or more applets rendered in a web browser on the client system;

the one or more applets communicate with the server system using a remote procedure call (RPC) mechanism and a notification mechanism to generate the chart; and

the selected data is aggregated across a plurality of clinical trial sites.

20. A client system, comprising:

means for receiving, in a user interface on the client system, a user request for a display of selected data aggregated from subject enrollment data in a server system pertaining to a clinical trial; and

means for, responsive to the user request, displaying on the client system a chart to graphically portray the selected data.

21. The system of claim 20, wherein the chart is to graphically portray numbers of subjects for a plurality of enrollment statuses or time intervals aggregated at a level from a group consisting:

a clinical trial site, a clinical trial protocol, and a clinical trial region; and

the clinical trial is selected from a plurality of trials.