Lessons from COVID-19 clinical trials and the concept of national clinical trials network_Chinese Journal of Evidence-Based Medicine

Authors：

YAO Chen ^1,2 ,  ZHAO Wenle ³

1. First Hospital, Peking University, Beijing 100034, P.R.China;
2. Clinical Research Institute, Peking University, Beijing 100191, P.R.China;
3. Department of Public Health Sciences, Medical University of South Carolina, Charleston 29425, SC, USA;

Corresponding?author：

ZHAO Wenle, Email: zhaow@musc.edu

Keywords：

Coronavirus disease (COVID-19); Clinical trial; National clinical trials network

DOI：

10.7507/1672-2531.202003069

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Since the outbreak of the coronavirus disease (COVID-19), more than 200 interventional clinical trials have been registered in Chinese Clinical Trial Registry (www.chictr.org.cn) and the US Clinical Trials Registry (www.clinicaltrials.gov), testing or going to test treatments of COVID-19 in China from January 23^rd, 2020 to March 5^th, 2020. This situation has drawn attentions from various sectors of society. This article summarizes the basic design features of 249 registered COVID-19 clinical trials in China, compares them with National Clinical Trials Network practices in the USA, and describes a concept of national clinical trials network as a strategy to enhance quality and efficiency of clinical research in cases like COVID-19 outbreak as well as other disease fields.

Citation： YAO Chen, ZHAO Wenle. Lessons from COVID-19 clinical trials and the concept of national clinical trials network. Chinese Journal of Evidence-Based Medicine, 2020, 20(5): 497-503. doi: 10.7507/1672-2531.202003069 Copy

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Development of rapid advice guidelines in public health emergency

1.	World Health Organization. Statement on the second meeting of the International Health Regulations (2005) Emergency Committee regarding the outbreak of novel coronavirus (2019-nCoV). Available from: https://www.who.int/news-room/detail/30-01-2020-statement-on-the-second-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-outbreak-of-novel-coronavirus-(2019-ncov).
2.	World Health Organization. Coronavirus disease (COVID-19) technical guidance: early investigations protocols. Available from: https://www.who.int/emergencies/diseases/novel-coronavirus- 2019/technical-guidance/early-investigations.
3.	上海國際問題研究院. 中國抗擊新型冠狀病毒: 進展與前景. Available from: http://www.siis.org.cn/Content/Info/4U9RHLFMTUQR.
4.	Code of Federal Regulations. Title 21: food and drugs. 2017. Available from: https://www.govinfo.gov/content/pkg/CFR-2017-title21-vol5/pdf/CFR-2017-title21-vol5.pdf.
5.	中國臨床試驗注冊中心. 新型冠狀病毒肺炎臨床研究索引. Available from: http://www.chictr.org.cn.
6.	U.S. National Library of Medicine. ClinicalTrials.gov. Available from: http://www.clinicaltrials.gov.
7.	金雪娟, 王吉耀. 冠狀病毒感染疾病-19 臨床研究的思考和建議. 中華消化雜志, 2020. DOI: 10.3760/cma.j.issn.0254-1432.2020.0004.
8.	陳峰, 姜慶五, 郝元濤, 等. 關于科學, 規范, 有序地開展新型冠狀病毒肺炎相關臨床試驗的建議. 中華流行病學雜志, 2020, 41(3): 301-302.
9.	元唯安, 胡義揚, 唐健元, 等. 當下新型冠狀病毒肺炎中藥臨床研究的若干思考. 上海中醫藥雜志, 2020. DOI: 10.16305/j.1007-1334.2020.04.099.
10.	羅藝, 蔣志偉. 新冠肺炎應急臨床試驗設計中的統計學考慮. 中國臨床藥理學與治療學, 2020, 25(2): 121-125.
11.	曾繁典. 新型冠狀病毒肺炎疫情下相關臨床試驗的倫理考量. 醫藥導報, 2020. Available from: http://kns.cnki.net/kcms/detail/42.1293.R.20200227.1803.003.html.
12.	陳永, 楊澤民, 陳吉生, 等. 新型冠狀病毒肺炎藥物臨床試驗現狀及研究進展. 今日藥學, 2020. Available from: http://kns.cnki.net/kcms/detail/44.1650.R.20200226.0753.002.html.
13.	宋杲, 成夢群, 魏賢文. 新型冠狀病毒臨床試驗注冊特點分析: 基于美國ClinicalTrials.gov和中國臨床研究注冊中心數據庫. 中國人獸共患病學報, 2020. Available from: http://kns.cnki.net/kcms/detail/35.1284.R.20200224.1525.002.html.
14.	鄧宏勇, 趙詠芳, 許吉, 等. 中醫藥防治新型冠狀病毒肺炎臨床循證研究注冊動態分析報告. 上海中醫藥雜志, 2020, 54(3): 14-15.
15.	張曉雨, 趙晨, 孫楊, 等. 推動建立臨床試驗協作與共享機制: 疫情蔓延期的戰略思考. 中醫雜志, 2020. Available from: http://kns.cnki.net/kcms/detail/11.2166.r.20200219.1436.002.html.
16.	World Medical Association. Declaration of Helsinki - Ethical principles for medical research involving human subjects. Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/..
17.	Freedman B. Equipoise and the ethics of clinical research. N Engl J Med, 1987, 317(3): 141-145.
18.	國務院應對新冠肺炎疫情聯防聯控機制科研攻關組. 關于規范醫療機構開展新型冠狀病毒肺炎藥物治療臨床研究的通知. Available from: http://www.most.gov.cn/tztg/202002/t20200225_151897.htm.
19.	中華人民共和國國家衛生健康委員會規劃發展與信息化司. 2017 年我國衛生健康事業發展統計公報. Available from: http://www.nhc.gov.cn/guihuaxxs/s10743/201806/44e3cdfe11fa4c7f928c879d435b6a18.shtml.
20.	Moore TJ, Zhang H, Anderson G, et al. Estimated costs of pivotal trials for novel therapeutic agents approved by the US Food and Drug Administration, 2015-2016. JAMA Intern Med, 2018, 178(11): 1451-1457.
21.	Clinical Trials Arena. Clinical trial delays: America’s patient recruitment dilemma. Available from: https://www.clinicaltrialsarena.com/analysis/featureclinical-trial-patient-recruitment/.
22.	National Cancer Institute. NCI’s National Clinical Trials Network. Available from: https://www.cancer.gov/research/areas/clinical-trials/nctn.
23.	National Institute of Neurological Disorders and Stroke. NIH Stroke Trials Network. Available from: https://www.nihstrokenet.org/.
24.	National Institute of Allergy and Infectious Disease. The HIV Prevention Trials Network. Available from: https://www.hptn.org/.
25.	National Institutes of Health. Funding Opportunity Announcement RFA-NS-13-012 NINDS Stroke Trials Network - National Clinical Coordinating Center (U01). Available from: https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-13-012.html.
26.	National Institutes of Health. Funding Opportunity Announcement RFA-NS-13-016 NINDS Stroke Trials Network - National Data Management Center (U01). Available from: https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-13-016.html.
27.	National Institutes of Health. Funding Opportunity Announcement RFA-NS-13-011 NINDS Stroke Trials Network - Regional Coordinating Stroke Centers (U10). Available from: https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-13-011.html.
28.	National Institutes of Health. NIH Single IRB Policy for Multi-site Research. Available from: https://grants.nih.gov/policy/humansubjects/single-irb-policy-multi-site-research.htm.

Chinese Journal of Evidence-Based Medicine

Lessons from COVID-19 clinical trials and the concept of national clinical trials network

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