ENDPOINT DEVELOPMENT PROCESS

• US 20100023346A1
• Filed: 07/24/2009
• Published: 01/28/2010
• Est. Priority Date: 07/25/2008
• Status: Active Grant

• Current Assignee: eResearchTechnology, Inc. (Explorer Holdings, Inc.)
• Original Assignee: Invivodata Incorporated (Explorer Holdings, Inc.)
• Inventors: GWALTNEY, Chad, PATY, Jean, SHIELDS, Alan, TIPLADY, Brian
• Granted Patent: US 8,380,531 B2
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: G06Q 10/00 Administration; Management
• CPC Class Codes: G06Q 30/0203 Market surveys; Market polls
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A system for developing and producing clinical endpoints based on patient reported outcome data utilizing algorithms to generate decision rules to evaluate patient reported outcome type questionnaire is provided. The questionnaires can include health-related quality of life questionnaires and can predict the reliability of endpoints in supporting one or more medical labeling claims.

Claims

1. A method of clinical trial endpoint development comprising:

a) administering one or more questions to a subject who is administered a medical product or a placebo, wherein said one or more questions are administered to said subject by a portable electronic device, wherein said device records data about said subject'"'"'s response to said one or more questions;

b) analyzing said data;

c) developing one or more clinical trial endpoints based on said analysis of said data; and

,

d) using said one or more clinical trial endpoints in a clinical trial as an indicator to determine when one or more goals of said clinical trial is reached.

2. The method of claim 1, wherein said step a) of administering a questionnaire to a subject is part of a pilot trial.

3. The method of claim 1, wherein said analyzing said data is performed on said portable electronic device.

4. The method of claim 1, wherein said analyzing said data comprises sending said data to a data analysis system, wherein said data is analyzed.

5. The method of claim 1, wherein said clinical trial tests a medical product or a placebo on a human subject.

6. The method of claim 1, wherein said developing comprises modifying said questionnaire based on said evaluation of data and repeating steps a) and b).

7. The method of claim 1, wherein said analyzing comprises psychometric validation of said data.

8. The method of claim 1, wherein said one or more questions comprises at least one a health-related quality of life (HRQOL) question.

9. The method of claim 1, wherein said administering comprises prompting said subject to answer said one or more questions.

10. The method of claim 9, wherein prompting lasts for the duration of said clinical trial.

11. The method of claim 9, wherein prompting occurs at a pre-scheduled time or a random time.

12. The method of claim 4, wherein said data is sent to said data analysis system by a wireless connection or wired connection.

13. The method of claim 1, wherein said data comprises information on the time said subject responds to said one ore more questions, the date said subject responds to said one ore more questions, or the location of said portable electronic device when said subject responds to said one ore more questions.

14. The method of claim 1, wherein one of said one or more goals of said clinical trial is to assess a label claim of a medical product.

15. The method of claim 1, wherein step b) comprises analyzing said data for one or more evaluative indicators.

16. The method of claim 15, wherein said analyzing comprises a statistical hypothesis test of said evaluative indicators.

17. The method of claim 16, wherein said statistical hypothesis test is a t-test or a probability value test.

18. The method of claim 1, wherein said data comprises patient-reported outcome (PRO) data or metadata.

19. A method of developing a questionnaire for use in a clinical trial comprising:

a) administering one or more questions to a subject who is administered a medical product or a placebo and recording said subject'"'"'s response to said one or more questions as a first set of data;

b) analyzing said first set of data to determine the validity or reliability of said question;

c) accepting said question for collection in step e), or modifying said question and providing it again in step a);

d) collecting said one or more questions into a questionnaire;

e) administering said questionnaire to a subject in a clinical trial, wherein said administering is by a portable electronic device, wherein said portable electronic device records said subject in a clinical trial'"'"'s response as a second set of data;

f) analyzing said second set of data to determine if a pre-determined clinical trial endpoint has been reached in said clinical trial.

20. The method of claim 19, wherein said questionnaire comprises one or more HRQOL questions.

21. The method of claim 19, wherein step b) comprises analyzing said data for one or more evaluative indicators.

22. The method of claim 19, wherein said first or second set of data comprises PRO data or metadata.

23. A computer program product comprising a computer readable medium having computer program logic encoded thereon for enabling a processor to develop a clinical trial endpoint comprising:

a) a receiving procedure that enables a processor to receive data from a portable electronic device, wherein said data comprises a response to one or more questions responded to by a subject who was administered a medical product or a placebo, wherein said one or more questions are administered to said subject by said portable electronic device;

b) an analyzing procedure to analyze said data;

c) an output procedure to provide one or more clinical trial endpoints based on said analysis of said data.

24. The computer program product of claim 23, wherein step b) comprises analyzing said data for one or more evaluative indicators.

25. The computer program product of claim 23, wherein said data comprises PRO data or metadata.

26. A computer system for clinical trial endpoint development comprising a computer readable medium having computer program logic encoded thereon, wherein said computer program logic comprises instructions, which comprise:

a) input instructions for receiving data from a portable electronic device, wherein said data comprises a response to one or more questions responded to by a subject who was administered a medical product or a placebo, wherein said one or more questions are administered to said subject by said portable electronic device;

b) analysis instructions for analyzing said data;

c) output instructions for providing one or more clinical trial endpoints based on said analysis of said data.

27. The computer system of claim 26, wherein step b) comprises analyzing said data for one or more evaluative indicators.

28. The computer system of claim 26, wherein said data comprises PRO data or metadata.

29. The computer system of claim 26, further comprising instructions to send information to said portable electronic device, wherein said computer system is remote from said portable electronic device.

30. The computer system of claim 29, wherein said information comprises one or more questions.

31. A computer program product comprising a computer readable medium having computer program logic encoded thereon for enabling a processor to develop a questionnaire for use in a clinical trial comprising:

a) a receiving procedure that enables a processor to receive data from a portable electronic device, wherein said data comprises a response to one or more questions responded to by a subject who was administered a medical product or a placebo;

b) an analyzing procedure to analyze said data to determine the validity or reliability of said question, wherein said procedure collects a question determined to be valid or reliable and outputs them for use in a clinical trial questionnaire or said procedure modifies a question determined to be invalid or unreliable and outputs them for administration to a subject who is administered a medical product or a placebo;

c) an output procedure to provide a validated or reliable question for use in a clinical trial or to provide a modified question to a subject who is administered a medical product or a placebo.

32. The computer program product of claim 31, wherein step b) comprises analyzing said data for one or more evaluative indicators.

33. The computer program product of claim 31, wherein said data comprises PRO data or metadata.

34. A computer system for providing a questionnaire for use in a clinical trial comprising a computer readable medium having computer program logic encoded thereon, wherein said computer program logic comprises instructions, which comprise:

a) input instructions for receiving data from a portable electronic device, wherein said data comprises a response to one or more questions responded to by a subject who is administered a medical product or a placebo;

b) analysis instructions for analyzing data to determine the validity or reliability of said question, wherein said procedure collects a question determined to be valid or reliable and outputs them for use in a clinical trial questionnaire or said procedure modifies a question determined to be invalid or unreliable and outputs them for administration to a subject who is administered a medical product or a placebo;

c) output instructions to provide a validated or reliable question for use in a clinical trial or to provide a modified question to a subject who is administered a medical product or a placebo.

35. The computer system of claim 34, wherein said data comprises PRO data or metadata.