突发公共卫生事件对药物临床试验实施的影响及应对策略

The impacts of public health emergencies on the implementation of drug clinical trials and the corresponding strategies

本文旨在探讨突发公共卫生事件期间药物临床试验实施和科学监管的考虑,为工业界、学术界及监管机构提供技术参考。通过全面收集并梳理新型冠状病毒肺炎疫情对中国药物临床试验实施的影响及面临的挑战,参考国外相关指南建议,结合国内应急机制、措施及医疗实践特点,对突发公共卫生事件期间中国药物临床试验可以采取的应对策略进行研究并形成科学建议。申请人应采取积极措施应对突发公共卫生事件对药物临床试验实施带来的影响,所有措施的首要目的是保护受试者安全。在此基础上,尽可能保证试验数据质量,并将疫情对临床试验完整性的影响降至最低。应急状态下,采用多种灵活、先进的电子化手段,并经标准化后实施,是保障安全有效推进药物临床试验的重要方法。申请人应与研究者、研究机构、独立数据监察委员会等及时沟通交流并共同建立风险分担机制,必要时应与监管机构进行沟通交流,以确保措施的科学可行并予以落实。

This article aims to discuss the considerations for the conduct and scientific supervision of drug clinical trials during public health emergencies,looking forward to providing the technical reference for industry,academia and regulatory agency.By collecting and summarizing the impacts and challenges that faced in China when conducting the clinical trials during Coronavirus Disease 2019(COVID-19)epidemic,referenced to the relevant foreign guidelines,as well as consulted the domestic emergency mechanisms,measures and medical practice situation,we discussed the appropriate measures that can be taken in clinical trials during public health emergencies and formed scientific recommendations.Sponsors should take active measures to deal with the impacts of public health emergencies on the conduct of drug clinical trials.The primary purpose of all measures taken is to assure the safety of trial participants.On this basis,it should be done to ensure the quality of the trial data as much as possible and to minimize the impacts of the epidemic on trial integrity.To conduct the drug clinical trials safely and effectively in an emergency state,it was an important method that using a variety of flexible and advanced electronic means which would be implemented after standardization.Sponsors should communicate with researchers,investigational sites,and independent data monitoring committees in time,and the risk sharing mechanism should be established.If necessary,sponsors should communicate with regulatory agency to ensure that the measures are scientifically feasible,and carried out later.