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.
Abstract
摘要
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本文引用的文献
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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.
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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.
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Ethics of Safety Reporting of a Clinical Trial.临床试验安全性报告的伦理学
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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.
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Reporting of Adverse Events in Published and Unpublished Studies of Health Care Interventions: A Systematic Review.已发表和未发表的医疗保健干预研究中不良事件的报告：一项系统评价。
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