An investigation based on registered clinical trials on Chinese clinical trial registry for exploring the factors of impacting quality of clinical trials_Chinese Journal of Evidence-Based Medicine

Authors：

 WU Taixiang ¹ , Minawaer ABUDU ¹ , BIAN Zhaoxiang ² , SHANG Hongcai ³ , YANG Lei ⁴ , HAO Yuan ⁵ , KONG Xiangyu ⁶ , CHEN Shuo ⁷ ,  LI Youping ¹

1. Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;
2. Hong Kong Chinese Medicine Clinical Study Centre, School of Chinese Medicine, Hong Kong Baptist University, Hongkong, 999077, P.R.China;
3. Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, 100700, P.R.China;
4. Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, 610041, P.R.China;
5. Chang’an Hospital, Xi’an, 710016, P.R.China;
6. Chengdu Medical School, Chengdu, 610083, P.R.China;
7. Mianyang Central Hospital, Mianyang, 621099, P.R.China;

Corresponding?author：

WU Taixiang, Email: chictr@vip.qq.com; LI Youping, Email: yzmylab@hotmail.com

Keywords：

Randomized controlled trial; Protocol; Quality; SPIRIT

DOI：

10.7507/1672-2531.201801036

Video：

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Abstract Full text Figures/Tables Video References Cited by

Objectives To explore potential important factors that impacts the quality of Chinese trials. Methods We randomly selected clinical studies registered in the Chinese Clinical Trial Registry during March 15th, 2016 to December 31st, 2016. The randomized controlled trials protocols were retrieved to assess the quality based on the SPIRIT guideline, their data management plan and statement of sharing individual participant data were also investigated. Results 457 studies were randomly selected from 2 205 studies by a rate of 1∶4. Among them, 393 were randomized controlled trials. Pre-market trials of new medicines conducted by the State Clinical Study Bases had better quality of protocols. In total, 4 protocols were rated as high quality (1.02%) and 21 as higher quality (5.34%). 129 studies in 457 (28.23%) described a correct data management system including a paper case record form and an electronic data capture. 392 studies (85.77%) stated that public sharing IPD will be available. Conclusions Poorly developed protocol and lack of professional data management system are common issues in some Chinese clinical studies. We feel confident that most Chinese investigators are good in learning considering that they are willing to share the IPD of their studies. Providing education and technical support focus on three technical aspects are crucial: introducing SPIRIT for developing protocol, providing standardized data management system, and introducing the concept of transparency include sharing IPD which is an essential requirement of clinical study ethics.

Citation： WU Taixiang, Minawaer ABUDU, BIAN Zhaoxiang, SHANG Hongcai, YANG Lei, HAO Yuan, KONG Xiangyu, CHEN Shuo, LI Youping. An investigation based on registered clinical trials on Chinese clinical trial registry for exploring the factors of impacting quality of clinical trials. Chinese Journal of Evidence-Based Medicine, 2018, 18(6): 526-531. doi: 10.7507/1672-2531.201801036 Copy

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1. Available at: http://news.163.com/15/0821/07/ B1HCKC0O00014JHT.html.
2. Available at: http://view.news.qq.com/original/intouchtoday/n3273.html.
3. Available at: http://www.jjckb.cn/2016-09/09/c_135673951.htm.
4. Available at: http://www.sciencealert.com/80-of-the-data-in-chinese-clinical-trial-is-fabricated.
5. CFDA. Seek for opinions on the revised announcement on the opinions concerning the handling of the verification of data produced from the drug clinical trials. Available at: http://www.sda.gov.cn/WS01/CL0778/171506.html.
6. The Supreme People's Court of the People's Republic of China. Explanations for proper law of against the illegal cases of data fabrication aimed to obtain marketing approval of new drugs and medical devices. Available at: http://www.court.gov.cn/fabu-xiangqing-39752.html.
7. Zarin DA, Tse T. Sharing individual participant data (IPD) within the context of the trial reporting system (TRS). PLoS Med, 2016, 13(1): e1001946.
8. Clinical trial data management guidance, CFDA. Available at: http://www.sda.gov.cn/WS01/CL0087/160961.html.
9. Chinese clinical trial registry: registration guidance. Available at: http://www.chictr.org.cn/registryen.aspx.
10. Chinese clinical trial registry: a statement of promoting sharing the clinical trial data. Available at: http://www.chictr.org.cn/uploads/documents/2e943b2f0a754cf982b141875f7bc4be.pdf.
11. Chinese clinical trial registry: notification for opening the web-based medical research public management platform ResMan, an Electronic Data Capture (EDC). Available at: http://www.chictr.org.cn/uploads/documents/201706/a7e75fbdb4624df58ca522e27b466090.pdf.
12. Joseph SR, Richard L, Cary PG. The importance of clinical trial data sharing to ward more open science. Circ Cardiovasc Qual Outcomes, 2012, 5(2): 238-240.
13. Altman DG, Furberg CD, Grimshaw JM, et al. Lead editorial: trials-using the opportunities of electronic publishing to improve the reporting of randomised trials. Trials, 2006, 7(1): 6.
14. Hopkins C, Sydes M, Murray G, et al. UK publicly funded clinical trials units supported a controlled access approach to share individual participant data but highlighted concerns. J Clin Epidemiol, 2016, 70: 17-25.
15. Darren BT, Joyce B, Christopher B, et al. Sharing clinical trial data, a proposal from the international committee of medical journal editors. BMJ, 2016, 144(1): 11-13.
16. Vickers AJ. Whose data set is it anyway? Sharing raw data from randomized trials. Trials, 2006, 7: 15.
17. Chan AW, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Rev Panam Salud Publica, 2015, 38(6): 506-514.
18. Chan AW, Tetzlaff JM, G?tzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ, 2013, 346: e7586.
19. 吳泰相, 李幼平, 劉關鍵, 等. 中國臨床試驗注冊中心及中國循證醫學中心提高我國臨床試驗質量的策略和措施. 中國循證醫學雜志, 2010, 10(11): 1243-1248.

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An investigation based on registered clinical trials on Chinese clinical trial registry for exploring the factors of impacting quality of clinical trials

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