Patent ID: 8380531

Claim:
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 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.