Analysis of regulatory strategies for remote decentralized clinical trials
Traditional clinical trials are often expensive,relatively inefficient,and may also cause additional burden for trial participants.The use of new technologies and methods in remote decentralized clinical trials(DCT)can help to improve clinical trials efficiency.The application of DCT brings several benefits,but also poses new challenges for the regulation of clinical trials.In this study,the current situation and issues surrounding the use of digital technology in clinical trials were analyzed,as well as the regulatory practices and regulatory scientific research on DCT in Europe and the United States.The proposed regulatory strategies for DCT in China were investigated,taking into account the current development and regulatory considerations of DCT in China.
NETL
NSTL
万方数据
