System for clinical trial subject compliance

• US 8,065,180 B2
• Filed: 04/02/2001
• Issued: 11/22/2011
• Est. Priority Date: 04/02/2001
• Status: Expired due to Fees

• Current Assignee: eResearchTechnology, Inc. (Explorer Holdings, Inc.)
• Original Assignee: Invivodata Incorporated (Explorer Holdings, Inc.)
• Inventors: Hufford, Michael, Peterson, David, Paty, Jean A., Shiffman, Saul
• Primary Examiner(s): GOTTSCHALK, MARTIN A
• Application Number:
  US09/825,533
• Publication Number:
  US 20020143563A1
• Time in Patent Office: 3,886 Days
• Field of Search: 705/2, 705/3, 705/4, 365/230.03, 600/529
• US Class Current: 705/11
• CPC Class Codes: G06Q 10/0639 Performance analysis of employees; Performance analysis of enterprise or organisation operations
• 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 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

The present invention is designed to develop research protocols for clinical trials. The invention also can track and enhance subject compliance with a research protocol. The invention further provides evaluability data related to subject performance in the clinical trial. According to an alternative embodiment of the invention, a portable electronic device is used to query and collect data from the subject.

Claims

1. A method of determining if action is needed regarding subject compliance during a current clinical trial, wherein said current clinical trial comprises a group of subjects participating in said current clinical trial, comprising the steps of:

providing data on timeliness of a data entry from a previous clinical trial and either a) historical subject compliance data from said previous clinical trial or b) historical protocol data from said previous clinical trial, wherein said historical subject compliance data comprise data on a ratio of completed assessments to expected assessments, data on a subject'"'"'s compliance with a medication regimen, data on a disease episode, or data on a characteristic of a subject'"'"'s disease state, and wherein said historical protocol data comprise a question posed to a subject, a frequency of prompting of a subject during a day or week, an amount of time allotted for a subject to respond to a question, or a condition mandating removal of a subject from data analysis or from participation in a clinical trial;

generating a preferred compliance threshold for use during said current clinical trial by quantitative analysis of said data on timeliness of a data entry from said previous clinical trial and either a) said historical subject compliance data from said previous clinical trial or b) said historical protocol data from said previous clinical trial; and

obtaining subject compliance information from a subject in said group of subjects participating in said current clinical trial comprising using a portable electronic device capable of displaying information and receiving and storing input from a user to obtain said subject compliance information from said subject in said group of subjects participating in said current clinical trial; and

comparing said subject compliance information from said subject in said group of subjects participating in said current clinical trial to said preferred compliance threshold to determine if said action is needed for said subject in said group of subjects participating in said current clinical trial, wherein said action comprises removing all or part of data from said subject in said group of subjects participating in said current clinical trial from data analysis, removing all or part of the data from said subject in said group of subjects participating in said current clinical trial from a report, removing said subject in said group of subjects participating in said current clinical trial from said current clinical trial, prompting said subject in said group of subjects participating in said current clinical trial to view said portable electronic device, alerting clinical staff to contact said subject in said group of subjects participating in said current clinical trial regarding compliance with said current clinical trial, providing compliance feedback to said subject in said group of subjects participating in said current clinical trial to encourage continued compliance with said current clinical trial, providing compliance feedback to said subject in said group of subjects participating in said current clinical trial to remediate poor compliance with said current clinical trial, providing a report on the compliance of said subject in said group of subjects participating in said current clinical trial to said clinical staff or a clinical trial sponsor, or training said clinical staff in the monitoring and correcting of subject compliance.

2. The method of claim 1, further comprising a step of prompting said action if the step of comparing indicates that said action is needed.

3. The method of claim 1, wherein said compliance threshold remains unchanged throughout said current clinical trial.

14. The method of claim 1, wherein said action further comprises reducing a number of occurrences of said step of obtaining subject compliance information.

25. The method of claim 1, wherein said step of providing comprises providing said historical protocol data, and wherein said step of generating further comprises quantitative analysis of said historical protocol data.

26. The method of claim 1, 4, or 11, wherein said step of generating employs multiple linear regression, discriminant function analysis, logistic regression, neural networks, classification trees or regression trees.

27. The method of claim 1 or 11, wherein said step of providing employs at least one database containing the historical subject compliance data.

28. The method of claim 1, 4, or 11, wherein said historical subject compliance data further comprise data on whether a subject had a relationship with a doctor or other medical professional, data on a number or percent of prompts not replied to by a subject, data on a subject'"'"'s sleep/wake cycle, data on whether a subject had a bowel movement, data on an amount of time a portable electronic device is in suspend mode, data on a subject'"'"'s gender, or data on a subject'"'"'s location.

29. The method of claim 1, 4, or 11, wherein said action further comprises decreasing said portable electronic device'"'"'s prompt frequency, increasing said portable electronic device'"'"'s prompt frequency, or increasing the loudness of an audible prompt of said portable electronic device.

30. The method of claim 1, 4, or 11, wherein said action further comprises administering a reward to said subject in said group of subjects participating in said current clinical trial.

4. A method of prompting an action if subject noncompliance indicates said action is needed during a current clinical trial wherein said current clinical trial comprises a group of subjects participating in said current clinical trial, comprising the steps of:

providing data on timeliness of a data entry and historical subject compliance data from a previous clinical trial, wherein said historical subject compliance data comprise data on a ratio of completed assessments to expected assessments, data on a subject'"'"'s compliance with a medication regimen, data on a disease episode, or data on a characteristic of a subject'"'"'s disease state;

generating a predictive algorithm for predicting subject noncompliance by quantitative analysis of said historical subject compliance data;

translating said predictive algorithm into at least one prediction rule for use during said current clinical trial;

obtaining subject compliance information from a subject in said group of subjects participating in said current clinical trial comprising using a portable electronic device capable of displaying information and receiving and storing input from a user to obtain said subject compliance information;

comparing said subject compliance information from said subject in said group of subjects participating in said current clinical trial to the at least one prediction rule to determine if said action is needed for said subject in said group of subjects participating in said current clinical trial; and

prompting said action if the step of comparing indicates that said action is needed.

5. The method of claim 4, wherein said step of providing further comprises providing historical protocol data from said previous clinical trial and wherein said step of generating further comprises quantitative analysis of said historical protocol data, wherein said historical protocol data comprise a question posed to a subject, a frequency of prompting of a subject during a day or week, an amount of time allotted for a subject to respond to a question, or a condition mandating removal of a subject from data analysis or from participation in a clinical trial.

6. The method of claim 4, further comprising a step of creating an evaluability database adapted to store data related to subject compliance.

7. The method of claim 6, further comprising a step of providing access to said evaluability database to a sponsor to allow said sponsor to make a determination regarding said subject in said group of subjects participating in said current clinical trial based on data from said evaluability database.

8. The method of claim 6, wherein said evaluability database is tailored to a condition affecting said subject in said group of subjects participating in said current clinical trial.

9. The method of claim 4, wherein said step of providing employs at least one database containing said the historical subject compliance data.

10. The method of claim 4, wherein said prediction rule is generated without data from activities of said current clinical trial.

11. A method of determining if an action is needed regarding subject compliance during a current clinical trial, wherein said current clinical trial comprise a group of subjects participating in said current clinical trial, comprising the steps of:

providing data on timeliness of a data entry and historical subject compliance data from a previous clinical trial, wherein said historical subject compliance data comprises data on a ratio of completed assessments to expected assessments, data on a subject'"'"'s compliance with a medication regimen, data on a disease episode, or data on a characteristic of a subject'"'"'s disease state;

generating an algorithm by quantitative analysis of said data on timeliness of a data entry and said historical subject compliance data;

translating said algorithm into a decision rule for use during said current clinical trial;

obtaining subject compliance information from a subject in said group of subjects participating in said current clinical trial; and

comparing said subject compliance information from said subject in said group of subjects participating in said current clinical trial to said decision rule on a portable electronic device or a computer to determine if said action is needed for said subject in said group of subjects participating in said current clinical trial, wherein said action comprises removing all or part of data from said subject in said group of subjects participating in said current clinical trial from data analysis, removing all or part of data from said subject in said group of subjects participating in said current clinical trial from a report, removing said subject in said group of subjects participating in said current clinical trial from said current clinical trial, prompting said subject in said group of subjects participating in said current clinical trial to view said portable electronic device, alerting clinical staff to contact said subject in said group of subjects participating in said current clinical trial regarding compliance with said current clinical trial, providing compliance feedback to said subject in said group of subjects participating in said current clinical trial to encourage continued compliance with said current clinical trial, providing compliance feedback to said subject in said group of subjects participating in said current clinical trial to remediate poor compliance with said current clinical trial, providing a report on compliance of said subject in said group of subjects participating in said current clinical trial to said clinical staff or a clinical trial sponsor, or training said clinical staff in monitoring and correcting of subject compliance.

12. The method of claim 11, wherein said step of providing further comprises providing historical protocol data from said previous clinical trial and wherein said step of generating further comprises quantitative analysis of said historical protocol data, wherein said historical protocol data comprise a question posed to a subject, a frequency of prompting of a subject during a day or week, an amount of time allotted for a subject to respond to a question, or a condition mandating removal of a subject from data analysis or from participation in a clinical trial.

13. The method of claim 11, further comprising prompting said action if the step of comparing indicates that said action is warranted.

15. The method of claim 11, wherein said action further comprises increasing a number of occurrences of said step of obtaining said subject compliance information.

16. The method of claim 11, wherein said action further comprises giving a reward to said subject in said group of subjects participating in said current clinical trial.

17. The method of claim 11, wherein said step of obtaining comprises using a portable electronic device capable of displaying information and receiving and storing input from a user.

18. The method of claim 11, wherein said decision rule is generated without data from activities of said current clinical trial.

19. A computer readable medium suitable for use in an electronic device and having instructions recorded thereon for execution on said electronic device, said instructions comprising the steps of:

providing data on timeliness of a data entry from a previous clinical trial and either a) historical subject compliance data from said previous clinical trial or b) historical protocol data from said previous clinical trial, wherein said historical subject compliance data comprise data on a ratio of completed assessments to expected assessments, data on a subject'"'"'s compliance with a medication regimen, data on a disease episode, or data on a characteristic of a subject'"'"'s disease state, and wherein said historical protocol data comprise a question posed to a subject, a frequency of prompting of a subject during a day or week, an amount of time allotted for a subject to respond to a question, or a condition mandating removal of a subject from data analysis or from participation in a clinical trial; and

generating a preferred compliance threshold for use during a current clinical trial by quantitative analysis of said data on timeliness of a data entry from said previous clinical trial and either a) said historical subject compliance data from said previous clinical trial or b) said historical protocol data from said previous clinical trial, wherein said current clinical trial comprises a group of subjects participating in said current clinical trial,

obtaining subject compliance information from a subject in said group of subjects participating in said current clinical trial, comprising using a portable electronic device capable of displaying information and receiving and storing input from a user to obtain said subject compliance information from said subject in said group of subjects participating in said current clinical trial; and

comparing subject compliance information from said subject in said group of subjects participating in said current clinical trial to said preferred compliance threshold to determine if an action is needed for said subject in said group of subjects participating in said current clinical trial, wherein said action comprises removing all or part of data from said subject in said group of subjects participating in said current clinical trial from data analysis, removing all or part of data from said subject in said group of subjects participating in said current clinical trial from a report, removing said subject in said group of subjects participating in said current clinical trial from said current clinical trial, prompting said subject in said group of subjects participating in said current clinical trial to view said portable electronic device, alerting clinical staff to contact said subject in said group of subjects participating in said current clinical trial regarding compliance with said current clinical trial, providing compliance feedback to said subject in said group of subjects participating in said current clinical trial to encourage continued compliance with said current clinical trial, providing compliance feedback to said subject in said group of subjects participating in said current clinical trial to remediate poor compliance with said current clinical trial, providing a report on compliance of said subject in said group of subjects participating in said current clinical trial to said clinical staff or a clinical trial sponsor, or training said clinical staff in monitoring and correcting of subject compliance.

20. The computer readable medium of claim 19, wherein said compliance threshold remains unchanged throughout said current clinical trial.

31. The computer readable medium of claim 19, 21, 22, 23, or 24, wherein said historical subject compliance data further comprise data on whether a subject had a relationship with a doctor or other medical professional, data on a number or percent of prompts not replied to by a subject, data on a subject'"'"'s sleep/wake cycle, data on whether a subject had a bowel movement, data on an amount of time a portable electronic device is in suspend mode, data on a subject'"'"'s gender, or data on a subject'"'"'s location.

32. The computer readable medium of claim 19, 21, 22, 23, or 24, wherein said action further comprises decreasing said portable electronic device'"'"'s prompt frequency, increasing said portable electronic device'"'"'s prompt frequency, increasing the loudness of an audible prompt of said portable electronic device, or administering a reward to said subject in said group of subjects participating in said current clinical trial.

21. A computer readable medium suitable for use in an electronic device and having instructions recorded thereon for execution on said electronic device, said instructions comprising steps of:

providing data on timeliness of a data entry and historical subject compliance data from a previous clinical trial, wherein said historical subject compliance data comprise data on a ratio of completed assessments to expected assessments, data on a subject'"'"'s compliance with a medication regimen, data on a disease episode, or data on a characteristic of a subject'"'"'s disease state;

generating an algorithm reflective of said historical subject compliance data by quantitative analysis of said data on timeliness of a data entry and said historical subject compliance data;

translating said algorithm into at least one decision rule for analyzing subject compliance information during a current clinical trial, wherein said current clinical trial comprises a group of subjects participating in said current clinical trial;

obtaining said subject compliance information from a subject in said group of subjects participating in said current clinical trial;

comparing said subject compliance information from said subject in said group of subjects participating in said current clinical trial to said decision rule to determine if an action is needed for said subject in said group of subjects participating in said current clinical trial; and

prompting said action if the step of comparing indicates that said action is needed for said subject in said group of subjects participating in said current clinical trial, wherein said action comprises removing all or part of data from said subject in said group of subjects participating in said current clinical trial from data analysis, removing all or part of data from said subject in said group of subjects participating in said current clinical trial from a report, removing said subject in said group of subjects participating in said current clinical trial from said current clinical trial, prompting said subject in said group of subjects participating in said current clinical trial to view said portable electronic device, alerting clinical staff to contact said subject in said group of subjects participating in said current clinical trial regarding compliance with said current clinical trial, providing compliance feedback to said subject in said group of subjects participating in said current clinical trial to encourage continued compliance with said current clinical trial, providing compliance feedback to said subject in said group of subjects participating in said current clinical trial to remediate poor compliance with said current clinical trial, providing a report on compliance of said subject in said group of subjects participating in said current clinical trial to said clinical staff or a clinical trial sponsor, or training said clinical staff in monitoring and correcting of subject compliance.

34. The computer readable medium of claim 21 or 24, wherein said decision rule is generated without data from activities of said current clinical trial.

22. A computer readable medium suitable for use in an electronic device and having instructions recorded thereon for execution on said electronic device, said instructions comprising steps of:

providing data on timeliness of a data entry from said previous clinical trial and either a) historical subject compliance data from said previous clinical trial or b) historical protocol data from said previous clinical trial, wherein said historical subject compliance data comprise data on a ratio of completed assessments to expected assessments, data on a subject'"'"'s compliance with a medication regimen, data on a disease episode, or data on a characteristic of a subject'"'"'s disease state, and wherein said historical protocol data comprise a question posed to a subject, a frequency of prompting of a subject during a day or week, an amount of time allotted for a subject to respond to a question, or a condition mandating removal of a subject from data analysis or from participation in a clinical trial;

generating a spectrum of compliance representative of said historical subject compliance data or said historical protocol data by quantitative analysis of said data on timeliness of a data entry and said historical subject compliance data or said historical protocol data;

obtaining subject compliance information from a subject in a group of subjects participating in a current clinical trial, wherein said current clinical trial comprises said group of subjects participating in said current clinical trial;

comparing said subject compliance information from said subject in said group of subjects participating in said current clinical trial to said spectrum of compliance representative to determine if an action is needed for said subject in said group of subjects participating in said current clinical trial; and

prompting said action if said step of comparing indicates that said action is needed for said subject in said group of subjects participating in said current clinical trial, wherein said action comprises removing all or part of data from said subject in said group of subjects participating in said current clinical trial from data analysis, removing all or part of data from said subject in said group of subjects participating in said current clinical trial from a report, removing said subject in said group of subjects participating in said current clinical trial from said current clinical trial, prompting said subject in said group of subjects participating in said current clinical trial to view said portable electronic device, alerting clinical staff to contact said subject in said group of subjects participating in said current clinical trial regarding compliance with said current clinical trial, providing compliance feedback to said subject in said group of subjects participating in said current clinical trial to encourage continued compliance with said current clinical trial, providing compliance feedback to said subject in said group of subjects participating in said current clinical trial to remediate poor compliance with said current clinical trial, providing a report on compliance of said subject in said group of subjects participating in said current clinical trial to said clinical staff or a clinical trial sponsor, or training said clinical staff in monitoring and correcting of subject compliance.

23. A computer readable medium suitable for use in an electronic device and having instructions recorded thereon for execution on said electronic device, said instructions comprising steps of:

providing data on timeliness of a data entry and historical subject compliance data from a previous clinical trial, wherein said historical subject compliance data comprise data on a ratio of completed assessments to expected assessments, data on a subject'"'"'s compliance with a medication regimen, data on a disease episode, or data on a characteristic of a subject'"'"'s disease state;

generating a predictive algorithm for predicting subject noncompliance by quantitative analysis of said data on timeliness of a data entry and said historical subject compliance data;

translating said predictive algorithm into at least one prediction rule for use during a current clinical trial;

obtaining subject compliance information from a subject in a group of subjects participating in said current clinical trial wherein said current clinical trial comprises said group of subjects participating in said current clinical trial;

comparing said subject compliance information from said subject in said group of subjects participating in said current clinical trial to said prediction rule to determine if an action is needed for said subject in said group of subjects participating in said current clinical trial; and

prompting said action if said step of comparing indicates that said action is needed for said subject in said group of subjects participating in said current clinical trial, wherein said action comprises removing all or part of the data from said subject in said group of subjects participating in said current clinical trial from data analysis, removing all or part of the data from said subject in said group of subjects participating in said current clinical trial from a report, removing said subject in said group of subjects participating in said current clinical trial from said current clinical trial, prompting said subject in said group of subjects participating in said current clinical trial to view said portable electronic device, alerting clinical staff to contact said subject in said group of subjects participating in said current clinical trial regarding compliance with said current clinical trial, providing compliance feedback to said subject in said group of subjects participating in said current clinical trial to encourage continued compliance with said current clinical trial, providing compliance feedback to said subject in said group of subjects participating in said current clinical trial to remediate poor compliance with said current clinical trial, providing a report on compliance of said subject in said group of subjects participating in said current clinical trial to said clinical staff or a clinical trial sponsor, or training said clinical staff in monitoring and correcting of subject compliance.

33. The computer readable medium of claim 23, wherein said prediction rule is generated without data from activities of said current clinical trial.

24. A computer readable medium suitable for use in an electronic device and having instructions recorded thereon for execution on said electronic device for determining if an action is needed regarding subject compliance during a current clinical trial, wherein said current clinical trial comprises a group of subjects participating in said current clinical trial, said instructions comprising steps of:

providing data on timeliness of a data entry and historical subject compliance data from a previous clinical trial, wherein said historical subject compliance data comprise data on a ratio of completed assessments to expected assessments, data on a subject'"'"'s compliance with a medication regimen, data on a disease episode, or data on a characteristic of a subject'"'"'s disease state;

generating an algorithm by quantitative analysis of said data on timeliness of a data entry and said historical subject compliance data;

translating said algorithm into at least one decision rule for use during said current clinical trial;

obtaining subject compliance information from a subject in said group of subjects participating in said current clinical trial; and

comparing said subject compliance information from said subject in said group of subjects participating in said current clinical trial to said decision rule to determine if said action is needed for said subject in said group of subjects participating in said current clinical trial, wherein said action comprises removing all or part of the data from said subject in said group of subjects participating in said current clinical trial from data analysis, removing all or part of the data from said subject in said group of subjects participating in said current clinical trial from a report, removing said subject in said group of subjects participating in said current clinical trial from said current clinical trial, prompting said subject in said group of subjects participating in said current clinical trial to view said portable electronic device, alerting clinical staff to contact said subject in said group of subjects participating in said current clinical trial regarding compliance with said current clinical trial, providing compliance feedback to said subject in said group of subjects participating in said current clinical trial to encourage continued compliance with said current clinical trial, providing compliance feedback to said subject in said group of subjects participating in said current clinical trial to remediate poor compliance with said current clinical trial, providing a report on compliance of said subject in said group of subjects participating in said current clinical trial to said clinical staff or a clinical trial sponsor, or training said clinical staff in monitoring and correcting of subject compliance.