Endpoint development process

• US 10,025,910 B2
• Filed: 11/06/2012
• Issued: 07/17/2018
• Est. Priority Date: 07/25/2008
• Status: Active Grant

• Current Assignee: eResearchTechnology, Inc. (Explorer Holdings, Inc.)
• Original Assignee: eResearchTechnology, Inc. (Explorer Holdings, Inc.)
• Inventors: Paty, Jean, Shields, Alan, Gwaltney, Chad, Tiplady, Brian
• Primary Examiner(s): Gilligan, Christopher L
• Application Number:
  US13/670,151
• Publication Number:
  US 20130159010A1
• Time in Patent Office: 2,079 Days
• 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 comprising:

a. prompting, by a first portable electronic device using a first prompting mechanism of said first portable electronic device, a first subject in a pilot trial to input a response to a first question;

b. automatically recording and storing said first subject'"'"'s response to said first question as a first set of data, wherein said first set of data comprises first metadata indicating an amount of time elapsed between said prompting by said first portable electronic device and said response to said first question;

c. prompting, by a second portable electronic device using a second prompting mechanism of said second portable electronic device, a second subject to input a response to a second question, wherein said first prompting mechanism and said second prompting mechanism are different and said first prompting mechanism or said second prompting mechanism comprises beeping, a voice, music, or a vibration;

d. automatically recording and storing said second subject'"'"'s response to said second question as a second set of data, wherein said second set of data comprises second metadata indicating an amount of time elapsed between said prompting by said second portable electronic device and said response to said second question;

e. analyzing, by one or more electronic devices, said first set of data and said second set of data to;

i. evaluate effectiveness of said first prompting mechanism and said second prompting mechanism; and

ii. determine validity or reliability of said first question and said second question;

f. selecting said first prompting mechanism or said second prompting mechanism for use during a subsequent clinical trial based on said analyzing; and

h. accepting said first question or said second question determined to be valid or reliable for use during said subsequent clinical trial based on said analyzing.

2. The method of claim 1, wherein said first question or said second question comprises one or more health-related quality of life questions.

3. The method of claim 1, wherein said first prompting mechanism or said second prompting mechanism is a random prompting mechanism.

4. The method of claim 1, wherein said first prompting mechanism or said second prompting mechanism is a scheduled prompting mechanism.

5. The method of claim 1, wherein said first set of data or said second set of data comprises information about patient-reported outcome data.

6. The method of claim 1, wherein said first subject in said pilot trial is administered a medical product or a placebo.

7. The method of claim 1, wherein a subject in said subsequent clinical trial is administered a medical product or a placebo.

8. The method of claim 1, wherein said pilot trial enrolls fewer subjects than said subsequent clinical trial.

9. The method of claim 1, wherein said first prompting mechanism comprises said beeping or said vibration.

10. The method of claim 9, wherein said first prompting mechanism is selected for use during said subsequent clinical trial.

11. The method of claim 10, wherein said first question is accepted for use during said subsequent clinical trial.

12. The method of claim 10, wherein said second question is accepted for use during said subsequent clinical trial.

13. The method of claim 1, wherein said second prompting mechanism comprises said beeping or said vibration.

14. The method of claim 13, wherein said second prompting mechanism is selected for use during said subsequent clinical trial.

15. The method of claim 14, wherein said first question is accepted for use during said subsequent clinical trial.

16. The method of claim 14, wherein said second question is accepted for use during said subsequent clinical trial.

17. A system comprising;

one or more computer processors; and

a non-transient computer readable medium comprising instructions operable, when executed by said one or more computer processors, to cause said system to;

a. receive data from a first portable electronic device, wherein said data comprises a response to a first question responded to by a first subject in a pilot trial, wherein said first subject was prompted by a first prompting mechanism of said first portable electronic device to input a response to said first question;

b. automatically record and store said first subject'"'"'s response to said first question as a first set of data, wherein said first set of data comprises first metadata indicating an amount of time elapsed between said prompt by said first prompting mechanism and said response to said first question;

c. receive data from a second portable electronic device, wherein said data comprises a response to a second question responded to by a second subject, wherein said second subject was prompted by a second prompting mechanism of said second portable electronic device to input a response to said second question, wherein said first prompting mechanism and said second prompting mechanism are different and, said first prompting mechanism or said second prompting mechanism comprises beeping, a voice, music, or a vibration;

d. automatically record and store said second subject'"'"'s response to said second question as a second set of data, wherein said second set of data comprises second metadata indicating an amount of time elapsed between said prompt by said second prompting mechanism and said response to said second question;

e. analyze said first set of data and said second set of data to;

i. evaluate effectiveness of said first prompting mechanism and said second prompting mechanism; and

ii. determine validity or reliability of said first question and said second question;

f. select said first prompting mechanism or said second prompting mechanism for use during a subsequent clinical trial based on said analysis; and

g. accept said first question or said second question determined to be valid or reliable for use during said subsequent clinical trial based on said analysis.

18. The system of claim 17, wherein said first prompting mechanism or said second prompting mechanism is a random prompting mechanism.

19. The system of claim 17, wherein said first prompting mechanism or said second prompting mechanism is a scheduled prompting mechanism.

20. The system of claim 17, further comprising a non-transient computer readable medium comprising instructions operable, when executed by said one or more processors, to cause said system to analyze said first set of data or said second set of data for one or more evaluative indicators.

21. The system of claim 17, wherein said first set of data or said second set of data comprises information about patient-reported outcome data.

22. The system of claim 17, wherein said first subject in said pilot trial is administered a medical product or a placebo.

23. The system of claim 17, wherein a subject in said subsequent clinical trial is administered a medical product or a placebo.

24. The system of claim 17, wherein said pilot trial enrolls fewer subjects than said subsequent clinical trial.

25. The system of claim 17, wherein said first question or said second question comprises one or more health-related quality of life questions.

26. The system of claim 17, wherein said first prompting mechanism comprises said beeping or said vibration.

27. The system of claim 26, wherein said first prompting mechanism is selected for use during said subsequent clinical trial.

28. The system of claim 27, wherein said first question is accepted for use during said subsequent clinical trial.

29. The system of claim 27, wherein said second question is accepted for use during said subsequent clinical trial.

30. The system of claim 17, wherein said second prompting mechanism comprises said beeping or said vibration.

31. The system of claim 30, wherein said second prompting mechanism is selected for use during said subsequent clinical trial.

32. The system of claim 31, wherein said first question is accepted for use during said subsequent clinical trial.

33. The system of claim 31, wherein said second question is accepted for use during said subsequent clinical trial.