对临床试验中运用远程智能技术的监管策略的科学建议

Scientific Recommendations for Regulatory Strategies for the Use of Remote Intelligence Technologies in Clinical Trials

远程智能技术在临床试验中的运用,既带来多重获益,也为临床试验的监管带来挑战。美国FDA自2015年开始倡议在临床试验中运用移动技术和监管科学研究,并和杜克大学共同推动构建临床试验转型倡议组织(Clinical Trials Transformation Initiative,CTTI),积累了丰富的经验。本文对上述监管实践进行分析,结合国内监管现状,探索我国在临床试验中运用远程智能技术的监管策略。

The application of remote intelligence technology in clinical trials brings both multiple benefits and challenges to the regulation of clinical trials.Since 2015,FDA has initiated the regulatory scientific research on the use of mobile technology in clinical trials,and has worked with Duke University to build the Clinical Trials Transformation Initiative(CTTI),which has accumulated a wealth of experience.This paper analyzes the above regulatory practices and explores regulatory strategies for applying remote intelligence technology in clinical trials in China by combining the current regulatory situation in China.