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

• US 7,899,685 B2
• Filed: 04/08/2005
• Issued: 03/01/2011
• Est. Priority Date: 12/18/2001
• Status: Active Grant

• Current Assignee: Siebel Systems Inc. (Oracle Corporation)
• Original Assignee: Siebel Systems Inc. (Oracle Corporation)
• Inventors: Sundaresan, Sheela, Yang, Rachel, Thulsidas, Sathya, Wallach, Matt, Inampudi, Prasad
• Primary Examiner(s): Frenel; Vanel
• Application Number:
  US11/102,421
• Publication Number:
  US 20070250779A1
• Time in Patent Office: 2,153 Days
• Field of Search: 705/2, 707/10, 707/102, 600/509
• US Class Current: 705/2
• 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. A computer-readable storage medium having stored thereon a set of instructions which, when executed, perform a method comprising:

receiving, via a user interface on a client system, a user request for a display of selected data, wherein

the selected data is aggregated from subject enrollment data,

the subject enrollment data is stored in a database,

the subject enrollment data pertains to a clinical trial,

the selected data comprises one or more attributes for each subject participating in the clinical trial,

each of the one or more attributes is among a plurality of configurable attributes,

the each of the one or more attributes comprises one or more subject status states per clinical trial, and

each of the one or more subject status states is among a plurality of configurable status states;

responsive to the user request, generating a database query of the database, wherein

the database query is configured to generate the selected data by virtue of being configured to query the database;

storing the database query;

updating the user interface to display the database query;

receiving a selection input at the user interface, wherein

the selection input indicates selection of the database query via the user interface;

responsive to the receiving the selection input, generating the selected data by executing the database query on the database;

responsive to the generating the selected data, generating a chart, wherein

the chart portrays the selected data by graphically portraying the each of the one or more attributes, and

the each of the one or more attributes is selected from the plurality of configurable attributes; and

responsive to the generating the chart, displaying the chart on the display of the client system.

2. The computer-readable storage medium of claim 1, wherein the user interface is displayed within a web browser on the client system.

3. The computer-readable storage medium of claim 2, wherein the database is accessible through an Internet web portal running on a server system.

4. The computer-readable storage medium of claim 2, wherein the selected data is aggregated for a plurality of enrollment statuses.

5. The computer-readable storage medium of claim 4, wherein the enrollment statuses comprise at least two statuses from a group comprising:

screened,

re-screened,

screen failure,

enrolled,

completed, and

early termination.

6. The computer-readable storage medium of claim 4, wherein the chart is to graphically portray numbers of subjects aggregated at a selected level for the plurality of enrollment statuses.

7. The computer-readable storage medium of claim 2, wherein the selected data is aggregated to show variations over a time period.

8. The computer-readable storage medium of claim 7, wherein the selected data is aggregated at a plurality of periodic intervals.

9. The computer-readable storage medium of claim 8, wherein the chart is to graphically portray numbers of subjects aggregated at a selected level for the plurality of periodic intervals.

10. The computer-readable storage medium of claim 2, wherein the selected data is aggregated at a level from a group comprising:

a clinical trial site,

a clinical trial region, and

a clinical trial protocol.

11. The computer-readable storage medium of claim 2, wherein the web browser renders one or more applets to generate the user interface.

12. The computer-readable storage medium of claim 11, wherein the one or more applets communicate with the server system using a remote procedure call (RPC) mechanism and a notification mechanism.

13. The computer-readable storage medium of claim 11, wherein the one or more applets are java-script based.

14. A method, comprising:

receiving, in a user interface on a client system, a user request for a display of selected data, wherein

the selected data is aggregated from subject enrollment data

the subject enrollment data is stored in a database,

the subject enrollment data pertains to a clinical trial,

the selected data comprises one or more attributes for each subject participating in the clinical trial,

each of the one or more attributes is among a plurality of configurable attributes,

the each of the one or more attributes comprises one or more subject status states per clinical trial, and

each of the one or more subject status states is among a plurality of configurable status states;

responsive to the user request, generating a database query of the database, wherein

the database query is configured to generate the selected data by virtue of being configured to query the database;

storing the database query;

updating the user interface to display the database query;

receiving a selection input at the user interface, wherein

the selection input indicates selection of the database query via the user interface;

responsive to the receiving the selection input, generating the selected data by executing the database query on the database;

responsive the generating the selected data, generating a chart, wherein

the chart portrays the selected data by graphically portraying the each of the one or more attributes, and

the each of the one or more attributes is selected from the plurality of configurable attributes; and

responsive to the generating the chart, displaying the chart on the display of the client system.

15. The method of claim 14, 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.

16. A client system, comprising:

means for receiving, in a user interface on the client system, a user request for a display of selected data, wherein

the selected data is aggregated from subject enrollment data,

the subject enrollment data is stored in a database,

the subject enrollment data pertains to a clinical trial,

the selected data comprises one or more attributes for each subject participating in the clinical trial,

each of the one or more attributes is among a plurality of configurable attributes,

the each of the one or more attributes comprises one or more subject status states per clinical trial, and

each of the one or more subject status states is among a plurality of configurable status states;

means for generating a database query of the database, wherein

the means for generating is responsive to the user request, and

the database query is configured to generate the selected data by virtue of being configured to query the database;

means for storing the database query;

means for updating the user interface to display the database query;

means for receiving a selection input at the user interface, wherein

the selection input indicates selection of the database query via the user interface;

means for generating the selected data by executing the database query on the database, wherein

the means for generating is responsive to the receiving the selection input;

means for generating a chart, responsive to the means for generating the selected data, wherein

the chart portrays the selected data by graphically portraying the each of the one or more attributes, and

the each of the one or more attributes is selected from the plurality of configurable attributes; and

means for, responsive to the generating the chart, displaying the chart on the display of the client system.

17. The system of claim 16, 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 comprising:

a clinical trial site,

a clinical trial protocol, and

a clinical trial region; and

the clinical trial is selected from a plurality of trials.