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North American regulatory agencies can and should make clinical trial data publicly available.北美监管机构能够且应该公开临床试验数据。
CMAJ. 2016 Feb 2;188(2):96-97. doi: 10.1503/cmaj.150679. Epub 2015 Oct 13.
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Behind closed doors.门后。
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Clinical trial data: to disclose or not to disclose?临床试验数据：披露还是不披露？
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Is a poster presentation really a "printed publication"?海报展示真的算是“印刷出版物”吗？
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Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011.1991年至2011年抗生素随机临床试验中研究目的的知情同意书
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Secrecy or transparency? The future of regulatory trial data.保密还是透明？监管试验数据的未来。
CMAJ. 2017 Feb 6;189(5):E185-E186. doi: 10.1503/cmaj.161088. Epub 2016 Nov 14.

本文引用的文献

1
Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments.奥司他韦治疗成人和儿童流感：临床研究报告的系统评价和监管意见摘要。
BMJ. 2014 Apr 9;348:g2545. doi: 10.1136/bmj.g2545.
2
Increasing value and reducing waste: addressing inaccessible research.提高价值，减少浪费：解决研究的不可获取性问题。
Lancet. 2014 Jan 18;383(9913):257-66. doi: 10.1016/S0140-6736(13)62296-5. Epub 2014 Jan 8.
3
World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.《世界医学协会赫尔辛基宣言：涉及人类受试者的医学研究伦理原则》
JAMA. 2013 Nov 27;310(20):2191-4. doi: 10.1001/jama.2013.281053.
4
Agomelatine efficacy and acceptability revisited: systematic review and meta-analysis of published and unpublished randomised trials.重新评估阿戈美拉汀的疗效和可接受性：已发表和未发表随机试验的系统评价和荟萃分析。
Br J Psychiatry. 2013 Sep;203(3):179-87. doi: 10.1192/bjp.bp.112.120196.
5
Unlocking Health Canada's cache of trade secrets: mandatory disclosure of clinical trial results.揭开加拿大卫生部商业机密的面纱：临床试验结果的强制披露
CMAJ. 2012 Feb 7;184(2):194-9. doi: 10.1503/cmaj.110721. Epub 2011 Aug 29.
6
Opening up data at the European Medicines Agency.欧洲药品管理局开放数据。
BMJ. 2011 May 10;342:d2686. doi: 10.1136/bmj.d2686.
7
Confidentiality laws and secrecy in medical research: improving public access to data on drug safety.医学研究中的保密法与保密性：改善公众获取药物安全数据的途径
Health Aff (Millwood). 2007 Mar-Apr;26(2):483-91. doi: 10.1377/hlthaff.26.2.483.
8
Underreporting research is scientific misconduct.隐瞒研究成果属于科研不端行为。
JAMA. 1990 Mar 9;263(10):1405-8.

North American regulatory agencies can and should make clinical trial data publicly available.

作者信息

Persaud Nav, Doshi Peter

机构信息

Department of Family and Community Medicine (Persaud) and Li Ka Shing Knowledge Institute (Persaud), St. Michael's Hospital, Toronto, Ont.; Department of Family and Community Medicine (Persaud), University of Toronto, Toronto, Ont.; Department of Pharmaceutical Health Services Research (Doshi), School of Pharmacy, University of Maryland, Baltimore, Md.

出版信息

CMAJ. 2016 Feb 2;188(2):96-97. doi: 10.1503/cmaj.150679. Epub 2015 Oct 13.

DOI:10.1503/cmaj.150679
PMID:26464136
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4732955/
Abstract
摘要