新发突发传染性疾病疫情初期临床研究设计与实施的思考

临床试验方案是开展临床试验的核心，是保证临床试验结果科学性、可靠性和准确性的重要依据。在新发突发传染病疫情初期，由于临床诊疗的紧迫性、临床研究的必要性、疾病认知的不充分、研究环境的特殊性、社会环境变化的可能性和研究团队的不顺应性等问题，临床研究方案的设计具有独特性。通过结合临床试验方案设计的准则和疫情初期的实际情况，对新发突发传染病初期临床试验方案设计和实施中几个关键内容进行了简要分析，以期为临床试验方案设计提供参考

Consideration on the design and implementation of clinical research in the early period ofemerging infectious diseases

The clinical trial protocol is the core of clinical trial, indispensable to the scientificity, reliability and accuracy of clinical trial results. In the early stage of emerging infectious diseases, the design of clinical trial protocol is unique due to the urgency of clinical diagnosis and treatment, the necessity of clinical research, the inadequacy of disease knowledge, the particularity of research environment, the possible changes of social environment and the inadaptability of research team. We considered the actual early epidemic situation, and analyzed several key contents in design and implementation of clinical trial protocol, in order to provide reference for the design of clinical trial protocol.