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;
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.
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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
35 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; 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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. A method of developing a questionnaire for use in a clinical trial comprising:
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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. - View Dependent Claims (20, 21, 22)
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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:
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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 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. - View Dependent Claims (24, 25)
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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:
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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 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. - View Dependent Claims (27, 28, 29, 30)
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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:
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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 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. - View Dependent Claims (32, 33)
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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:
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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; 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. - View Dependent Claims (35)
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Specification