With the ongoing improvement in the resources and quality of real-world data(RWD),including historical data and concurrent external data,an increasing number of researchers are focusing on leveraging external data to provide more comprehensive and effective evidence for evaluating the safety and efficacy of drugs and medical devices.This is particularly crucial in fields such as rare diseases and pediatrics,where conducting large-scale randomized controlled trials is often impractical.Therefore,innovative analytical methods are essential for efficiently utilizing these data.In this context,this paper aims to systematically review and introduce the research methods for borrowing external data in clinical trials,while comparing the advantages and disadvantages of various methods.The goal is to provide valuable references for researchers and promote more efficient and accurate use of external data in clinical trials.
关键词
真实世界研究/外部数据/药物和医疗器械/临床试验/统计分析方法
Key words
real-world study/external data/drugs and medical devices/clinical trials/statistical methods
维普
万方数据