Clinical trial endpoint development process
First Claim
Patent Images
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, wherein said one or more questions comprise at least one health-related quality of life (HRQOL) question;
b) analyzing said data, wherein said analyzing comprises a statistical analysis of responses to said at least one HRQOL question;
c) developing at least one validated HRQOL question based on said analysis, wherein said developing comprisesi) determining whether said at least one HRQOL question is an unqualified HRQOL question or a validated HRQOL question based on a capacity of said at least one HRQOL question to serve as an evaluative indicator,ii) for said unqualified HRQOL question, revising and/or recreating said unqualified HRQOL question, and repeating steps a) and b); and
retaining said revised and/or recreated unqualified HRQOL question as a validated HRQOL question based on a capacity of said revised and/or recreated unqualified HRQOL question to serve as an evaluative indicator;
d) collecting responses from more than one subject administered said validated HRQOL question;
e) developing one or more clinical trial endpoints based on said responses to said validated HRQOL question; and
f) assessing a label claim of said medical product tested in a clinical trial comprising said one or more clinical trial endpoints.
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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.
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Citations
53 Claims
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1. A method of clinical trial endpoint development comprising:
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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, wherein said one or more questions comprise at least one health-related quality of life (HRQOL) question; b) analyzing said data, wherein said analyzing comprises a statistical analysis of responses to said at least one HRQOL question; c) developing at least one validated HRQOL question based on said analysis, wherein said developing comprises i) determining whether said at least one HRQOL question is an unqualified HRQOL question or a validated HRQOL question based on a capacity of said at least one HRQOL question to serve as an evaluative indicator, ii) for said unqualified HRQOL question, revising and/or recreating said unqualified HRQOL question, and repeating steps a) and b); and retaining said revised and/or recreated unqualified HRQOL question as a validated HRQOL question based on a capacity of said revised and/or recreated unqualified HRQOL question to serve as an evaluative indicator; d) collecting responses from more than one subject administered said validated HRQOL question; e) developing one or more clinical trial endpoints based on said responses to said validated HRQOL question; and f) assessing a label claim of said medical product tested in a clinical trial comprising said one or more clinical trial endpoints. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. A computer program product comprising a non-transitory computer readable medium having computer program logic encoded thereon for enabling a processor to develop a clinical trial endpoint comprising:
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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 is administered a medical product or a placebo, wherein said one or more questions are administered to said subject by said portable electronic device, wherein said one or more questions comprise at least one health-related quality of life (HRQOL) question; b) an analyzing procedure to analyze said data, wherein said analyzing comprises a statistical analysis of responses to said at least one HRQOL question; c) a developing procedure to develop at least one validated HRQOL question, wherein said developing comprises i) determining whether said at least one HRQOL question is an unqualified HRQOL question or a validated HRQOL question based on a capacity of said at least one HRQOL question to serve as an evaluative indicator, ii) for said unqualified HRQOL question, revising and/or recreating said unqualified HRQOL question and repeating a) and b); and retaining said revised and/or recreated unqualified HRQOL question as a validated HRQOL question based on a capacity of said revised and/or recreated unqualified HRQOL question to serve as an evaluative indicator; d) a collecting procedure for collecting responses from more than one subject administered said validated HRQOL question; e) an output procedure to provide one or more clinical trial endpoints based on responses to said validated HRQOL question; and f) an assessing procedure for assessing a label claim of said medical product tested in a clinical trial comprising said one or more clinical trial endpoints. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34)
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35. A computer system for clinical trial endpoint development comprising a non-transitory computer readable medium having computer program logic encoded thereon, wherein said computer program logic comprises instructions, which comprise:
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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, wherein said one or more questions are administered to said subject by said portable electronic device, wherein said one or more questions comprise at least one health-related quality of life (HRQOL) question; b) analysis instructions for analyzing said data, wherein said analyzing comprises a statistical analysis of responses to said at least one HRQOL question; c) developing instructions for developing at least one validated HRQOL question, wherein said developing comprises i) determining whether said at least one HRQOL question is an unqualified HRQOL question or a validated HRQOL question based on a capacity of said at least one HRQOL question to serve as an evaluative indicator, ii) for said unqualified HRQOL question, revising and/or recreating said unqualified HRQOL question and repeating execution of a) and b); and retaining said revised and/or recreated unqualified HRQOL question as a validated HRQOL question based on a capacity of said revised and/or recreated unqualified HRQOL question to serve as an evaluative indicator; d) collecting instructions for collecting responses from more than one subject administered said validated HRQOL question; e) output instructions for providing one or more clinical trial endpoints based on said responses to said validated HRQOL question; and f) assessing instructions for assessing a label claim of said medical product tested in a clinical trial comprising said one or more clinical trial endpoints. - View Dependent Claims (36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53)
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Specification