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

• US 20080046469A1
• Filed: 06/06/2007
• Published: 02/21/2008
• 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: Ikeguchi, Edward, Devries, Glen, Sherif, Tarek, Goodman, Edwin
• Granted Patent: US 7,752,057 B2
• Time in Patent Office: Days
• US Class Current: 707/104.1
• 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 method of continuously analyzing trial data of an ongoing clinical trial, comprising the steps of:

accessing a trial database comprising trial data of subjects in said ongoing clinical trial;

performing statistical analysis on said trial data to determine a parameter of statistical significance without suspending said ongoing clinical trial;

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

repeating the steps of accessing, performing and determining during said ongoing clinical trial if it is determined that the result of said statistical analysis does not exceed said threshold value.

2. The method of claim 1, further comprising the step of receiving said threshold value selected by a user.

3. The method of claim 1, further comprising the step of alerting a user if it is determined that the result of the statistical analysis exceeds said threshold value.

4. The method of claim 1, wherein said parameter of statistical significance is a p-value;

and wherein the step of determining comprises the step of determining whether the result of said statistical analysis exceeds a p-value.

5. The method of claim 1, wherein the step of performing said statistical analysis comprises the step of calculating a rate of change in said parameter of statistical significance.

6. The method of claim 5, wherein the step of determining comprises the step of determining whether said calculated rate of change in said parameter of statistical significance exceeds a threshold rate of change in said parameter of statistical significance.

7. The method of claim 6, further comprising the step of receiving said threshold rate of change in said parameter of statistical significance selected by a user.

8. The method of claim 6, further comprising the step of alerting a user if it is determined that said calculated rate of change in said parameter of statistical significance exceeds said threshold rate of change in said parameter of statistical significance.

9. The method of claim 1, wherein said parameter of statistical significance is a p-value;

and wherein the step of performing statistical analysis comprises the step of calculating a rate of change in said p-value.

10. The method of claim 9, wherein the step of determining comprises the step of determining whether said calculated rate of change in said p-value exceeds a threshold rate of change in said p-value.

11. The method of claim 9, further comprising the step of 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.

12. The method of claim 1, wherein said ongoing clinical trial is a multi-arm study;

and

wherein the step of performing said statistical analysis comprises the step of determining a difference in said parameter of statistical significance among said multi-arm study.

13. The method of claim 12, wherein the step of determining comprises the step of determining whether said difference in said parameter of statistical significance among said multi-arm study exceeds a threshold difference in said parameter of statistical significance among said multi-arm study.

14. The method of claim 13, further comprising the step of alerting a user if it is determined that said difference in said parameter of statistical significance among said multi-arm study exceeds said threshold difference in said parameter of statistical significance among said multi-arm study.

15. The method of claim 1, wherein the step of performing said statistical analysis further comprising the steps of:

receiving a user defined criteria that defines a level of cleanliness of said parameter of statistical significance; and

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

16. The method of claim 1, wherein the step of repeating further comprises the step of waiting a predetermined time prior to repeating the steps of accessing, performing and determining during said ongoing clinical trial.

17. The method of claim 1, wherein said ongoing clinical trial is a blinded ongoing clinical trial;

and further comprising the steps;

accessing 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

generating 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.

18. The method of claim 17, further comprising the step of storing said grouped database in a memory device inaccessible by any user to preserve the blindness of said ongoing clinical trial.

19. The method of claim 1, wherein the step of performing comprises performing said statistical analysis on said trial data to determine said parameter of statistical significance without locking said trial database.

20. The method of claim 1, wherein said ongoing clinical trial is a blinded ongoing clinical trial;

and further comprising the steps;

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

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

accessing 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

generating a grouped database from said trial data satisfying said user defined criteria and said blinding database for statistical analysis, said grouped database grouping said trial data of said subjects based on their study group.

21. The method of claim 1, further comprising the step of generating trends in said parameter of statistical significance over time.

22. The Method of claim 21, further comprising the step of displaying said trends to an authorized user.

23. The method of claim 21, further comprising the step of 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.

24. A computer readable media comprising a code for continuously analyzing trial data of an ongoing clinical trial, said code comprising instructions for:

accessing a trial database comprising trial data of subjects in said ongoing clinical trial;

performing statistical analysis on said trial data to determine a parameter of statistical significance without suspending said ongoing clinical trial;

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

repeating the steps of accessing, performing and determining during said ongoing clinical trial if it is determined that the result of said statistical analysis does not exceed said threshold value.

25. The computer readable media of claim 24, further comprising instructions for receiving said threshold value selected by a user.

26. The computer readable media of claim 24, further comprising instructions for alerting a user if it is determined that the result of the statistical analysis exceeds said threshold value.

27. The computer readable media of claim 24, wherein said parameter of statistical significance is a p-value;

and wherein said instructions for determining comprises instructions for determining whether the result of said statistical analysis exceeds a predetermined p-value.

28. The computer readable media of claim 24, further comprising instructions for calculating a rate of change in said parameter of statistical significance.

29. The computer readable media of claim 28, further comprising instructions for determining whether said calculated rate of change in said parameter of statistical significance exceeds a threshold rate of change in said parameter of statistical significance.

30. The computer readable media of claim 29, further comprising instructions for receiving said threshold rate of change in said parameter of statistical significance selected by a user.

31. The computer readable media of claim 29, further comprising instructions for alerting a user if it is determined that said calculated rate of change in said parameter of statistical significance exceeds said threshold rate of change in said parameter of statistical significance.

32. The computer readable media of claim 24, wherein said parameter of statistical significance is a p-value;

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

33. The computer readable media of claim 32, further comprising instructions for determining whether said calculated rate of change in said p-value exceeds a threshold rate of change in said p-value.

34. The computer readable media of claim 32, further comprising 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.

35. The computer readable media of claim 24, wherein said ongoing clinical trial is a multi-arm study;

and further comprising instructions for determining a difference in said parameter of statistical significance among said multi-arm study.

36. The computer readable media of claim 35, further comprising instructions for determining whether said difference in said parameter of statistical significance among said multi-arm study exceeds a threshold difference in said parameter of statistical significance among said multi-arm study.

37. The computer readable media of claim 36, further comprising instructions for alerting a user if it is determined that said difference in said parameter of statistical significance among said multi-arm study exceeds said threshold difference in said parameter of statistical significance among said multi-arm study.

38. The computer readable media of claim 24, further comprising instructions for performing statistical analysis on said trial data to calculate said parameter of statistical significance without locking said trial database.

39. The computer readable media of claim 24, further comprising instructions for waiting a predetermined time prior to repeating the steps of accessing, performing and determining during said ongoing clinical trial.

40. The computer readable media of claim 24, wherein said ongoing clinical trial is a blinded ongoing clinical trial;

and further comprising instructions for;

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

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

accessing 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

generating a grouped database from said trial data satisfying said user defined criteria and said blinding database for statistical analysis, said grouped database grouping said trial data of said subjects based on their study group.

41. The computer readable media of claim 40, further comprising instructions for storing said grouped database in a memory device inaccessible by any user to preserve the blindness of said ongoing clinical trial.

42. The computer readable media of claim 24, further comprising instructions for generating trends in said parameter of statistical significance over time.

43. The computer readable media of claim 42, further comprising instructions for displaying said trends to an authorized user.

44. The computer readable media of claim 42, further comprising 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.

45. 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;

a processor for;

accessing said trial database to retrieve said trial data;

performing statistical analysis on said trial data to determine a parameter of statistical significance without suspending said ongoing clinical trial; and

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

wherein said processor is operable to repeatedly access, perform and determine during said ongoing clinical trial if it is determined that the result of said statistical analysis does not exceed said threshold value.

46. The system of claim 45, wherein said processor is operable to receive said threshold value selected by a user.

47. The system of claim 45, wherein said processor is operable to alert a user if it is determined that the result of the statistical analysis exceeds said threshold value.

48. The system of claim 45, wherein said parameter of statistical significance is a p-value;

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

49. The system of claim 45, wherein said processor is operable to calculate a rate of change in said parameter of statistical significance.

50. The system of claim 49, wherein said processor is operable to determine whether said calculated rate of change in said parameter of statistical significance exceeds a threshold rate of change in said parameter of statistical significance.

51. The system of claim 50, wherein said processor is operable to receive said threshold rate of change in said parameter of statistical significance from a user.

52. The system of claim 50, wherein said processor is operable to alert a user if it is determined that said calculated rate of change in said parameter of statistical significance exceeds said threshold rate of change in said parameter of statistical significance.

53. The system of claim 45, wherein said parameter of statistical significance is a p-value;

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

54. The system of claim 53, 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.

55. The system of claim 53, 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.

56. The system of claim 45, wherein said ongoing clinical trial is a multi-arm study;

and wherein said processor is operable to determine a difference in said parameter of statistical significance among said multi-arm study.

57. The system of claim 56, wherein said processor is operable to determine whether said difference in said parameter of statistical significance among said multi-arm study exceeds a threshold difference in said parameter of statistical significance among said multi-arm study.

58. The system of claim 57, wherein said processor is operable to alert a user if it is determined that said difference in said parameter of statistical significance among said multi-arm study exceeds said threshold difference in said parameter of statistical significance among said multi-arm study.

59. The system of claim 58, wherein said parameter of statistical significance is a p-value and a rate of change in the p-value.

60. The system of claim 45, wherein said processor is operable to wait a predetermined time prior to repeating the steps of accessing, performing and determining during said ongoing clinical trial.

61. The system of claim 45, wherein said ongoing clinical trial is a blinded ongoing clinical trial;

and wherein said processor is operable to;

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

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

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; and

generate a grouped database from said trial data satisfying said user defined criteria and said blinding database for statistical analysis, said grouped database grouping said trial data of said subjects based on their study group.

62. The system of claim 61, 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.

63. The system of claim 45, wherein said processor is operable to generate trends in said parameter of statistical significance over time.

64. The system of claim 63, further comprising a display drive for displaying said trends to an authorized user.

65. The system of claim 63, 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.