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, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ, 2013, 346: e7586.
|
19. |
吴泰相, 李幼平, 刘关键, 等. 中国临床试验注册中心及中国循证医学中心提高我国临床试验质量的策略和措施. 中国循证医学杂志, 2010, 10(11): 1243-1248.
|