摘要
2019年12月底,我国湖北省武汉市暴发新型冠状病毒肺炎(corona virus disease 2019,COVID-19),并在全球多个国家和地区发现病例。为寻找安全有效的治疗药物和治疗手段,全国各地迅速启动了大量临床试验。对受试者权益和安全的保护应优于对科学和社会获益的考虑。因此,临床试验参与各方应采取相应的措施来保护受试者的权益和安全。本文从临床试验的各个环节,探讨了新型冠状病毒肺炎临床试验的受试者保护问题,希望为临床试验参与各方提供参考,并为突发事件的临床试验受试者保护提供基本思路。
Since December 2019,COVID-19 has been found in Wuhan,Hubei Province of China,which has spread in many countries and regions around the world.A large number of clinical trials have been launched in China aiming to find safe and effective drugs and treatments.The protection of subjects’legal rights,welfare and safety should be superior to the consideration of scientific and social benefits.Therefore,all parties involved in clinical trials should take corresponding measures to protect subjects’legal rights,welfare and safety.This paper discussed about the protection of subjects’legal rights,welfare and safety in clinical trials of COVID-19 from all aspects of the clinical trials,aiming to provide reference for all parties involved in clinical trials and basic ideas for the protection of subjects’legal rights,welfare and safety in clinical trials of emergencies.
作者
张正付
李萌
王佳楠
ZHANG Zhengfu;LI Meng;WANG Jianan(Center for Food and Drug Inspection of NMPA,Beijing 100044,China)
出处
《中国临床药理学与治疗学》
CAS
CSCD
2020年第4期421-425,共5页
Chinese Journal of Clinical Pharmacology and Therapeutics
