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临床试验设计是试验成功的基石。结合多年来临床试验监查实践,笔者分析了大量专家论著,指出临床试验设计应重视《药物临床试验批件》附加要求,重视试验设计与前期立题依据、试验目的、药物特性的关联性、延续性,合理设计观测指标、观察时点,充分体现药物的作用特点和优势,制定合理的给药方案及疗程,合理考虑说明书。
Clinical trial design is the cornerstone of successful trials. Combined with the practice of clinical trial audits over the years, the author analyzed a large number of expert articles and pointed out that clinical trial design should pay attention to the additional requirements of the “Drug Clinical Trial Approvals”, and attach importance to the relationship between experimental design and the basis for the initial issues, the purpose of the trial, the characteristics of the drug, and continuation. Sexuality, rational design of observational indicators, observation time points, fully embody the characteristics and advantages of drugs, formulate a rational dosing regimen and course of treatment, and reasonably consider the instructions.