Statistical Methods for Borrowing External Data in Clinical Trials
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.
real-world studyexternal datadrugs and medical devicesclinical trialsstatistical methods
万方数据
维普
