新型冠状病毒肺炎等新发传染病相关临床研究的效率与规范原则  

Efficiency and norm principles of clinical research on drug therapy of emerging communicable diseases in China, such as COVID-19

作　　者：徐瑜璐 倪力强[2] XU Yu-lu;NI Li-qiang(Law School of Fudan University,SHANGHAI 200438,China;Shanghai University of Traditional Chinese Medicine,SHANGHAI 201203,China)

机构地区：[1]复旦大学法学院,上海200438 [2]上海中医药大学,上海201203

出　　处：《中国新药与临床杂志》2020年第12期722-726,共5页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：新发传染病突发时期的药物临床研究与一般时期有所不同,对研究的高效性期待更高,其研究规范也需结合疫情实际提出相应要求。国务院接连印发两份应急性部门规章,就有关"老药新用"治疗新型冠状病毒肺炎的相关临床研究提出"提高整体效率、促进规范开展"的总体要求,并作出具体安排。笔者诠释这两份规章的核心要求和意义,并结合既有法规,提出新发传染病的治疗药物临床研究应当遵循科学性、伦理性、效率性、规范性原则。When emerging infectious diseases break out, clinical research of drugs in epidemic prevention period is different from that in general period. The efficiency of the research is expected to be higher while the norms of research should also be combined with the epidemic situation. The state council successively issued two emergency response administrative regulations, which set forth the overall requirements for ‘improving the overall efficiency and promoting the standard development’ of clinical research on the drug therapy of COVID-19 with ‘new use of old drugs’ and made specific arrangements. By interpreting the core requirements and significance of the two regulations and combining the existing regulations, we proposed that clinical research on therapeutic drugs for emerging infectious diseases should follow scientific, ethical, efficient and normative principles.

关 键 词：新型冠状病毒肺炎 传染病 新出现 临床研究 效率 规范 

分 类 号：R-05[医药卫生]