System for clinical trial subject compliance
DC CAFCFirst Claim
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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.
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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.
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Citations
34 Claims
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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:
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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. - View Dependent Claims (2, 3, 14, 25, 26, 27, 28, 29, 30)
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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:
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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. - View Dependent Claims (5, 6, 7, 8, 9, 10)
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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:
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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. - View Dependent Claims (12, 13, 15, 16, 17, 18)
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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:
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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. - View Dependent Claims (20, 31, 32)
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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:
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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. - View Dependent Claims (34)
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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:
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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.
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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:
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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. - View Dependent Claims (33)
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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:
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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.
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Specification