System and method for continuous data analysis of an ongoing clinical trial

• US 7,752,057 B2
• Filed: 06/06/2007
• Issued: 07/06/2010
• Est. Priority Date: 09/22/2003
• Status: Active Grant

• Current Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Original Assignee: Medidata Solutions Incorporated (Dassault Systemes SA)
• Inventors: Devries, Glen M., Sherif, Tarek A., Goodman, Edwin, Ikeguchi, Edward F.
• Primary Examiner(s): O'Connor; Gerald J.
• Assistant Examiner(s): Raj; Rajiv J
• Application Number:
  US11/810,483
• Publication Number:
  US 20080046469A1
• Time in Patent Office: 1,126 Days
• Field of Search: 600/510, 600/300, 600/301, 705 2- 4
• US Class Current: 705/2
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16H 50/70 for mining of medical data, e.g. analysing previous cases of other patients
• CPC Class Codes: G16H 70/20 relating to practices or guidelines

Abstract

System and method of continuously analyzing trial data of an ongoing clinical trial is provided. A statistical analysis is performed on a trial database containing subject trial data without suspending the ongoing clinical trial. If the result of the statistical analysis does not exceed a predetermined threshold value, then the statistical analysis is repeated while the clinical trial is ongoing. In a blinded clinical trial, a grouped database is generated from the trial database and a blinding database prior to performing the statistical analysis. The grouped database groups the subject trial data according to the study groups. The ability to continuously monitor and analyze the trial data for statistical significance in tandem with data collection while the trial is ongoing provides many benefits to the researchers because the trial database no longer becomes the bottleneck in obtaining useful results and statistical analysis can be conducted on a near real-time basis without having to wait until completion of the trial.

Claims

1. A computer readable storage medium comprising computer executable instructions for continuously analyzing trial data of an ongoing clinical trial that, when executed by a processor, cause the processer to:

access a trial database comprising trial data of subjects in a blinded ongoing clinical trial comprising a multi-arm study while maintaining blindness of said blinded ongoing clinical trial;

access a blinding database comprising subject identifiers and associated study group identifiers, wherein a subject'"'"'s study group being identifiable by a study group identifier;

generate a grouped database from said trial database and said blinding database for statistical analysis, said grouped database grouping said trial data of said subjects based on their study group;

perform near real-time statistical analysis on said trial data to determine a parameter of statistical term of interest without suspending and while maintaining the blindness of said blinded ongoing clinical trial;

determine whether said parameter of statistical term of interest exceeds a threshold value and a difference in said parameter of statistical term of interest among said multi-arm study;

and

repeat the computer executable instructions for accessing said trial database, performing and determining during said blinded ongoing clinical trial and while maintaining the blindness of said blinded ongoing clinical trial until it is determined that said parameter of statistical term of interest exceeds said threshold value.

2. The computer readable storage medium of claim 1, further comprising computer executable instructions for receiving said threshold value selected by a user.

3. The computer readable storage medium of claim 1, wherein said parameter of statistical term of interest is a p-value;

and further comprising computer executable instructions for determining whether the result of said statistical analysis exceeds a predetermined p-value.

4. The computer readable storage medium of claim 1, further comprising computer executable instructions for calculating a rate of change in said parameter of term of interest.

5. The computer readable storage medium of claim 4, further comprising computer executable instructions for determining whether said calculated rate of change in said parameter of statistical term of interest exceeds a threshold rate of change in said parameter of statistical term of interest.

6. The computer readable storage medium of claim 5, further comprising computer executable instructions for receiving said threshold rate of change in said parameter of statistical term of interest selected by a user.

7. The computer readable storage medium of claim 5, further comprising computer executable instructions for alerting a user if it is determined that said calculated rate of change in said parameter of statistical term of interest exceeds said threshold rate of change in said parameter of statistical term of interest.

8. The computer readable storage medium of claim 1, wherein said parameter of statistical term of interest is a p-value;

and further comprising computer executable instructions for calculating a rate of change in said p-value.

9. The computer readable storage medium of claim 8, further comprising computer executable instructions for determining whether said calculated rate of change in said p-value exceeds a threshold rate of change in said p-value.

10. The computer readable storage medium of claim 8, further comprising computer executable instructions for alerting a user if it is determined that said calculated rate of change in said p-value exceeds said threshold rate of change in said p-value.

11. The computer readable storage medium of claim 1, further comprising computer executable instructions for determining whether said difference in said parameter of statistical term of interest among said multi-arm study exceeds a threshold difference in said parameter of statistical term of interest among said multi-arm study.

12. The computer readable storage medium of claim 11, further comprising computer executable instructions for alerting a user if it is determined that said difference in said parameter of statistical term of interest among said multi-arm study exceeds said threshold difference in said parameter of statistical term of interest among said multi-arm study.

13. The computer readable storage medium of claim 1, further comprising computer executable instructions for performing statistical analysis on said trial data to calculate said parameter of statistical term of interest without locking said trial database.

14. The computer readable storage medium of claim 1, further comprising computer executable instructions for waiting a predetermined time prior to repeating the steps of

accessing, performing and determining during said ongoing clinical trial.

15. The computer readable storage medium of claim 1, wherein said ongoing clinical trial is a blinded ongoing clinical trial;

and further comprising computer executable instructions for;

receiving a user defined criteria that defines a level of cleanliness of said parameter of statistical term of interest;

retrieving only those trial data satisfying said user defined criteria from said trial database.

16. The computer readable storage medium of claim 15, further comprising computer executable instructions for storing said grouped database in a memory device inaccessible by any user to preserve the blindness of said ongoing clinical trial.

17. The computer readable storage medium of claim 1, further comprising computer executable instructions for generating trends in said parameter of statistical term of interest over time.

18. The computer readable storage medium of claim 17, further comprising computer executable instructions for displaying said trends to an authorized user.

19. The computer readable storage medium of claim 17, further comprising computer executable instructions for predictive modeling of said trends to determine effects of altering study design of said ongoing clinical trial;

wherein said study design comprises at least one of the following;

length of said ongoing clinical trial, number of subjects enrolled in said ongoing clinical trial or distribution of enrolled subjects in said ongoing clinical trial.

40. The computer readable media of claim 1, further comprising computer readable instructions for alerting a user if it is determined that the result of the statistical analysis exceeds said threshold value.

20. A system for continuously analyzing trial data of an ongoing clinical trial, comprising:

a trial database comprising trial data of subjects in said ongoing clinical trial comprising a multi-arm study;

a blinding database comprising subject identifiers and associated study group identifiers, wherein a subject'"'"'s study group being identifiable by a study group identifier; and

a processor for;

accessing said trial database to retrieve said trial data while maintaining blindness of said blinded ongoing clinical trial;

accessing said blinded database to retrieve said subject identifiers and associated study group identifiers;

generating a grouped database from said trial database and said blinded database for statistical analysis, said grouped database grouping said trial data of said subjects based on their study group;

performing near real-time statistical analysis on said trial data to determine a parameter of statistical term of interest without suspending said ongoing clinical trial; and

determining whether the result of said statistical analysis exceeds a threshold value;

wherein said processor is operable to repeatedly access, perform and determine during said ongoing clinical trial until it is determined that the result of said statistical analysis exceeds said threshold value.

21. The system of claim 20, wherein said processor is operable to receive said threshold value selected by a user.

22. The system of claim 20, wherein said parameter of statistical term of interest is a p-value;

and wherein said processor is operable to determine whether said parameter of said statistical analysis exceeds a threshold p-value.

23. The system of claim 20, wherein said processor is operable to calculate a rate of change in said parameter of statistical term of interest.

24. The system of claim 23, wherein said processor is operable to determine whether said calculated rate of change in said parameter of statistical term of interest exceeds a threshold rate of change in said parameter of statistical term of interest.

25. The system of claim 24, wherein said processor is operable to receive said threshold rate of change in said parameter of statistical term of interest from a user.

26. The system of claim 24, wherein said processor is operable to alert a user if it is determined that said calculated rate of change in said parameter of statistical term of interest exceeds said threshold rate of change in said parameter of statistical term of interest.

27. The system of claim 20, wherein said parameter of statistical term of interest is a p-value;

and wherein said processor is operable to calculate a rate of change in said p-value.

28. The system of claim 27, wherein said processor is operable to determine whether said calculated rate of change in said p-value exceeds a threshold rate of change in said p-value.

29. The system of claim 27, wherein said processor is operable to alert a user if it is determined that said calculated rate of change in said p-value exceeds said threshold rate of change in said p-value.

30. The system of claim 20, wherein said processor is operable to determine whether said difference in said parameter of statistical term of interest among said multi-arm study exceeds a threshold difference in said parameter of statistical term of interest among said multi-arm study.

31. The system of claim 30, wherein said processor is operable to alert a user if it is determined that said difference in said parameter of statistical term of interest among said multi-arm study exceeds said threshold difference in said parameter of statistical term of interest among said multi-arm study.

32. The system of claim 31, wherein said parameter of statistical term of interest is a p-value and a rate of change in the p-value.

33. The system of claim 20, wherein said processor is operable to wait a predetermined time prior to repeating the steps of accessing, performing and determining during and while maintaining the blindness of said ongoing clinical trial.

34. The system of claim 20, wherein said processor is operable to:

receive a user defined criteria that defines a level of cleanliness of said parameter of statistical term of interest;

retrieve only those trial data satisfying said user defined criteria from said trial database.

35. The system of claim 20, further comprising a memory device for storing said grouped database in a memory device inaccessible by any user to preserve the blindness of said ongoing clinical trial.

36. The system of claim 20, wherein said processor is operable to generate trends in said parameter of statistical term of interest over time.

37. The system of claim 36, further comprising a display for displaying said trends to an authorized user.

38. The system of claim 36, wherein said processor is operable to predictive model of said trends to determine effects of altering study design of said ongoing clinical trial;

wherein said study design comprises at least one of the following;

length of said ongoing clinical trial, number of subjects enrolled in said ongoing clinical trial or distribution of enrolled subjects in said ongoing clinical trial.

39. The system of claim 20, wherein said processor is operable to perform statistical analysis on said trial data to calculate said parameter of statistical term of interest without locking said trial database.

41. The system of claim 20, wherein said processor is operable to alert a user if it is determined that the result of the statistical analysis exceeds said threshold value.