Drug clinical trial is a method of experimental epidemiology to evaluate the effectiveness and safety of medicines.This article introduced the types and design thought of innovation in drug clinical trial design,and provided methodological reference for related researches.Adaptive design is a complex and innovative clinical trial design,which can be divided into group sequential design,sample size re-estimation,seamless trial,enrichment design and master protocol design(basket trial,umbrella trial,platform trial,etc.)according to the purpose of adaptability.The adaptive design has greater adjustment flexibility,which overcomes the shortcomings of conventional clinical trials to a certain extent,then improves the validity of the trial results and the strength of the evidence.The design innovation and remodeling of drug clinical trials will provide more powerful evidence-based evidence for the realization of precision medicine.
关键词
药物临床试验/适应性设计/主方案设计/人工智能
Key words
drug clinical trial/adaptive design/master protocol design/artificial intelligence
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