Selecting and developing clinical outcome assessments in patient-focused drug development
In order to better incorporate patient input in clinical trials,the US Food and Drug Administration has included"patient-focused drug development"in the selection and development of clinical outcome assessments,and formulated a series of guidelines.Based on the third guiding principle,"Selecting,Developing,or Modifying Fit-for-Purpose Clinical Outcome Assessments",this article summarizes the clinical outcome assessments from five aspects:concept,development process,scoring mechanism,interference factors and sensitivity,and introduces four different types of clinical outcome assessments,providing new ideas for"patient-focused drug development"efficacy evaluation in clinical trials.
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