Strengthen the process report of clinical trials, promote full transparency of clinical trials_Chinese Journal of Evidence-Based Medicine

Authors：

DONG Chongya ¹ , YAN Xiaoyan ² , TIAN Ran ³ ,  BIAN Zhaoxiang ³ ,  YAO Chen ^1,2

1. Peking University First Hospital, Beijing, 100034, P.R.China;
2. Peking University Clinical Research Institute, Beijing, 100191, P.R.China;
3. School of Chinese Medicine, Hong Kong Baptist University, Hong Kong, 999077, P.R.China;

Corresponding author：

BIAN Zhaoxiang, Email: bianzxiang@gmail.com; YAO Chen, Email: yaochen@hsc.pku.edu.cn

Keywords：

Clinical trial; Process; Report; Transparency; Change face of clinical trial

DOI：

10.7507/1672-2531.201806071

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The concept of clinical trial transparency has been promoted for more than 40 years. The act of clinical trial registration, report guidelines development, and data sharing has has been strongly pushed forward and become a common practice. The clinical trial process being the key procedure of trial operation and quality control, determines the accuracy of the results. However, the process report of clinical trials is insufficient. In this article, we summarize the importance of clinical trial process report and provide corresponding suggestions. We propose that medical journals, reporting guidelines developers and clinical trial registration platforms should work together to strengthen the process report of clinical trials and promote full transparency of clinical trials.

Citation： DONG Chongya, YAN Xiaoyan, TIAN Ran, BIAN Zhaoxiang, YAO Chen. Strengthen the process report of clinical trials, promote full transparency of clinical trials. Chinese Journal of Evidence-Based Medicine, 2018, 18(7): 648-650. doi: 10.7507/1672-2531.201806071 Copy

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1. World Medical Association. World Medical Association declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA, 2013, 310(20): 2191-2194.
2. De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med, 2004, 351(12): 1250-1251.
3. Taichman DB, Sahni P, Pinborg A, et al. Data sharing statements for clinical trials. BMJ, 2017, 357: j2372.
4. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med, 2013, 158(3): 200-207.
5. Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Int J Surg, 2011, 9(8): 672-677.
6. Yan X, Dong C, Yao C. Protecting the accuracy of clinical trial data in China. Available at: https://blogs.bmj.com/bmj/2018/06/07/protecting-the-accuracy-of-clinical-trial-data-in-china.
7. 中共中央办公厅, 国务院办公厅. 关于进一步加强科研诚信建设的若干意见. Available at: http://www.gov.cn/zhengce/2018-05/30/content_5294886.htm.
8. ICH Expert Working Group. ICH harmonised tripartite guideline e9-statistical principles for clinical trials. Available at: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf.

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