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1
Under-reporting of safety data - cause for concern.安全数据报告不足——令人担忧的原因。
J Postgrad Med. 2022 Jul-Sep;68(3):129-130. doi: 10.4103/jpgm.jpgm_326_22.
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本文引用的文献

1
An audit of safety reporting in randomized controlled trials over a five-year period in a high impact factor journal.一项对高影响因子期刊五年间随机对照试验安全性报告的审核。
J Postgrad Med. 2022 Jul-Sep;68(3):133-137. doi: 10.4103/jpgm.JPGM_78_21.
2
Clinicians versus patients subjective adverse events assessment: based on patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).临床医生与患者主观不良事件评估：基于患者报告结局版通用不良事件术语标准（PRO-CTCAE）。
Qual Life Res. 2020 Nov;29(11):3009-3015. doi: 10.1007/s11136-020-02558-7. Epub 2020 Jun 20.
3
Ethics of Safety Reporting of a Clinical Trial.临床试验安全性报告的伦理学
Indian J Dermatol. 2017 Jul-Aug;62(4):387-391. doi: 10.4103/ijd.IJD_273_17.
4
Why clinical trial outcomes fail to translate into benefits for patients.为何临床试验结果无法转化为患者的益处。
Trials. 2017 Mar 14;18(1):122. doi: 10.1186/s13063-017-1870-2.
5
Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions: A Systematic Review.已发表和未发表的医疗保健干预研究中不良事件的报告：一项系统评价。
PLoS Med. 2016 Sep 20;13(9):e1002127. doi: 10.1371/journal.pmed.1002127. eCollection 2016 Sep.
6
Feasibility study to examine discrepancy rates in prespecified and reported outcomes in articles submitted to The BMJ.一项可行性研究，旨在检查提交给《英国医学杂志》的文章中预设结果与报告结果的差异率。
BMJ Open. 2016 Apr 22;6(4):e010075. doi: 10.1136/bmjopen-2015-010075.
7
Can we improve the performance and reporting of investigator-initiated clinical trials? Rheumatoid arthritis as an example.我们能否提高研究者发起的临床试验的绩效和报告质量？以类风湿关节炎为例。
Ann Rheum Dis. 2014 Oct;73(10):1755-60. doi: 10.1136/annrheumdis-2014-205821. Epub 2014 Aug 11.
8
Reporting of industry funded study outcome data: comparison of confidential and published data on the safety and effectiveness of rhBMP-2 for spinal fusion.行业资助研究结果数据报告：rhBMP-2 脊柱融合安全性和有效性的保密数据与发表数据比较。
BMJ. 2013 Jun 20;346:f3981. doi: 10.1136/bmj.f3981.

Under-reporting of safety data - cause for concern.

作者信息

Gajbhiye S

机构信息

Department of Pharmacology, All India Institute of Medical Sciences, Nagpur, Maharashtra, India.

出版信息

J Postgrad Med. 2022 Jul-Sep;68(3):129-130. doi: 10.4103/jpgm.jpgm_326_22.

DOI:10.4103/jpgm.jpgm_326_22
PMID:35975345
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9733522/
Abstract
摘要