Experience of the U.S.FDA clinical outcome assessment qualification and its enlightenment for China
Clinical outcome assessment(COA)refers to the methods utilized by patients,caregivers,physicians,or other assessors to appraise individual patient experiences,functioning or survival status.In recent years,the integration of patient engagement in drug and medical device research has progressively transitioned from a theoretical concept to practical implementation.COA has emerged as a pivotal metric for evaluating and approving drugs and medical devices.In 2016,the U.S.Food and Drug Administration(FDA)enacted legislation mandating qualification for COA,thereby providing robust support for clinical outcome assessment within the realm of drug and medical device regulation.This study aims to systematically review and analyze the process,departments and advancements in COA qualification.This will provide valuable references for the standardized application of COA and offer profound insights and inspiration for enhancing scientific decision-making in drug and medical device regulation.
clinical outcome assessmentqualificationdrug and medical device regulationAmerica
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