A narrative review on the development of the ethical review mode of multicenter clinical trials in China.

Autor:	Ding J; Department of Pharmacy, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.; Henan Engineering Research Center for Tumor Precision Medicine and Comprehensive Evaluation, Henan Cancer Hospital, Zhengzhou, China.; Henan Provincial Key Laboratory of Anticancer Drug Research, Henan Cancer Hospital, Zhengzhou, China., Yin Y; IQVIA RDS (Shanghai) Co., Ltd., Shanghai, China., Fang K; Department of Pharmacy, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China., Zhang W; Department of Pharmacy, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.; Henan Engineering Research Center for Tumor Precision Medicine and Comprehensive Evaluation, Henan Cancer Hospital, Zhengzhou, China.; Henan Provincial Key Laboratory of Anticancer Drug Research, Henan Cancer Hospital, Zhengzhou, China., Luo S; Department of Pharmacy, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.
Jazyk:	angličtina
Zdroj:	Annals of translational medicine [Ann Transl Med] 2022 Nov; Vol. 10 (22), pp. 1251.
DOI:	10.21037/atm-22-5213
Abstrakt:	Background and Objective: The number of new drug clinical trials in China is surging, and ethics review played an important part in clinical trials. However, there are certain problems of ethical review in China. This review aims to conduct a review to propose recommendations of an ethical review mode for multicenter clinical trials and ultimately contribute to improving the ethics review mechanism and the efficiency. Methods: A literature review, publication research and interpretation of the related governmental policies and requirements in China were conducted to collect available information for analysis of the current situation in terms of the various ethical review modes for multicenter clinical research. The literatures and information were searched and selected from national and international database and related governance website by following some inclusion and exclusion criteria. And a comparation with the relevant practical experience in the USA was conducted to support the proposing of recommendations to China by referring to some successful practice in the USA. Key Content and Findings: China has undergone several stages of development. The most traditional and least efficient model is institutional review boards (IRBs) review, which is most commonly used. After IRB review mode, other modes such as central IRB and single IRB review have emerged, which have improved the efficiency of ethical review. However, multiple challenges exist like, no clear definition of regulatory responsibilities and the consensus is not easy to be made due to the gap of interpretation and the unbalanced development on ethic review system from Chinese hospitals. Conclusions: The multicenter ethical review should adopt the conditional 'approval' mode of the leading site's ethical review decisions, gradually establish a single IRB review and select the best ethics committee. Regional ethics committees can gradually take responsibility for the primary review in the multicenter ethics review model and ultimately contribute to improving the mechanism and efficiency of the ethics review. Competing Interests: Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://atm.amegroups.com/article/view/10.21037/atm-22-5213/coif). YY is from IQVIA RDS (Shanghai) Co., Ltd. The other authors have no conflicts of interest to declare. (2022 Annals of Translational Medicine. All rights reserved.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu