1. |
Krleza-Jerić K, Chan AW, Dickersin K, et al. Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1). BMJ, 2005, 330(7497): 956-958.
|
2. |
Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet, 2001, 357(9263): 1191-1194.
|
3. |
Perneger TV. Sharing raw data: another of Francis Galton's ideas. BMJ, 2011, 342: d3035.
|
4. |
International Stroke Trial Collaborative Group. The international stroke trial (IST): a randomised trial of aspirin, subcutaneous heparin, both, or neither among 19 435 patients with acute ischaemic stroke. Lancet, 1997, 349(9065): 1569-1581.
|
5. |
Drazen JM. Sharing individual patient data from clinical trials. N Engl J Med, 2015, 372(3): 201-202.
|
6. |
Koenig F, Slattery J, Groves T, et al. Sharing clinical trial data on patient level: opportunities and challenges. Biom J, 2015, 57(1): 8-26.
|
7. |
Eichler HG, Abadie E, Breckenridge A, et al. Open clinical trial data for all? A view from regulators. PLoS Med, 2012, 9(4): e1001202.
|
8. |
Krumholz HM, Peterson ED. Open access to clinical trials data. JAMA, 2014, 312(10): 1002-1003.
|
9. |
Mello MM, Francer JK, Wilenzick M, et al. Preparing for responsible sharing of clinical trial data. N Engl J Med, 2013, 369(17): 1651-1658.
|
10. |
Ebrahim S, Sohani ZN, Montoya L, et al. Reanalyses of randomized clinical trial data. JAMA, 2014, 312(10): 1024-1032.
|
11. |
Tudur SC, Dwan K, Altman DG, et al. Sharing individual participant data from clinical trials: an opinion survey regarding the establishment of a central repository. PLoS One, 2014, 9(5): e97886.
|
12. |
Zarin DA, Tse T. Sharing individual participant data (IPD) within the context of the trial reporting system (TRS). PLoS Med, 2016, 13(1): e1001946.
|
13. |
Zarin DA, Tse T. Medicine. Moving toward transparency of clinical trials. Science, 2008, 319(5868): 1340-1342.
|
14. |
Zarin DA. Participant-level data and the new frontier in trial transparency. N Engl J Med, 2013, 369(5): 468-469.
|
15. |
Ross JS, Lehman R, Gross CP. The importance of clinical trial data sharing: toward more open science. Circ Cardiovasc Qual Outcomes, 2012, 5(2): 238-240.
|
16. |
Vickers AJ. Whose data set is it anyway? Sharing raw data from randomized trials. Trials, 2006, 7: 15.
|
17. |
Editorial. Establishing transparency to restore trust in clinical trials. Lancet Neurol, 2006, 5(7): 551.
|
18. |
临床数据造假, 政策逼出的潜规则. Available at: http://news.163.com/15/0821/07/B1HCKC0O00014JHT.html.
|
19. |
80% of data in Chinese clinical trials have been fabricated. Available at: https://www.sciencealert.com/80-of-the-data-in-chinese-clinical-trial-is-fabricated.
|
20. |
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.
|
21. |
US Department of Health and Human Services, National Institutes of Health, National Heart Lung and Blood Institute. Biologic specimen and data repository information coordinating center. Available at: https://biolincc.nhlbi.nih.gov/home/.
|
22. |
Johnson & Johnson Announces Clinical Trial Data Sharing Agreement with Yale School of Medicine. Available at: https://www.jnj.com/news/all/johnson-and-johnson-announces-clinical-trial-data-sharing-agreement-with-yale-school-of-medicine.
|
23. |
Piwowar HA, Chapman WW. Public sharing of research datasets: a pilot study of associations. J Informetr, 2010, 4(2): 148-156.
|
24. |
ClinicalTrials.gov protocol registration data element definitions for interventional and observational studies. Available at: https://prsinfo.clinicaltrials.gov/definitions.html.
|
25. |
新华社. 中国和印度加入世卫组织国际临床试验注册平台. 中华人民共和国中央人民政府门户网站. Available at: http://www.gov.cn/jrzg/2007-07/25/content_697236.htm.
|
26. |
吴泰相, 李幼平, 刘关键, 等. 临床试验注册制度与循证医学. 中国循证医学杂志, 2007, 7(4): 239-243.
|
27. |
中国临床试验注册中心关于共享临床试验原始数据的公告. Available at: http://www.chictr.org.cn/uploads/documents/201801/6805c684f6ac4e4d8dae96ef8964d2a7.pdf.
|
28. |
中国临床试验注册中心关于上传临床试验结果数据的公告. Available at: http://www.chictr.org.cn/uploads/documents/727014d82f5a49f7a6de703b6c664af1.pdf.
|
29. |
中国临床试验注册中心关于免费使用基于互联网的临床研究公共管理平台(电子数据收集管理系统)的公告. Available at: http://www.chictr.org.cn/uploads/documents/201712/c9e00ca56df94f19aae642770545d501.pdf.
|
30. |
USA FDA. FDA AA801 and the final rule. Available at: https://www.clinicaltrials.gov/ct2/manage-recs/fdaaa#WhichTrialsMustBeRegistered.
|
31. |
Taichman DB, Backus J, Baethge C, et al. Sharing clinical trial data. BMJ, 2016, 532: i255.
|
32. |
WHO Statement on Public Disclosure of Clinical Trial Results. Available at: http://www.who.int/ictrp/results/WHO_Statement_results_reporting_clinical_trials.pdf.
|
33. |
Goldacre B. The WHO joint statement from funders on trials transparency. BMJ, 2017, 357: j2816.
|