Dal-Ré Rafael, Caplan Arthur L
Clinical Research, BUC (Biosciences UAM+CSIC) Programme, International Campus of Excellence, Universidad Autónoma de Madrid, Madrid, Spain.
Division of Medical Ethics, Langone Medical Center, New York University, New York, NY, USA.
Eur J Clin Invest. 2015 Sep;45(9):895-8. doi: 10.1111/eci.12484. Epub 2015 Aug 6.
Several requirements and regulations have been issued to promote clinical trial transparency through prospective registration of trials, disclosure of results, access to trial reports submitted to regulatory agencies and access to anonymized patient-level data. Clinical trial results are disseminated through articles. Yet, many present outcome reporting bias. Open access to trial data will help to deter outcome reporting bias. However, this is not enough to clinicians. Access to trial protocols by journal staff has proven rather inefficacious in preventing outcome reporting bias. Two proposals have been suggested or implemented to tackle outcome reporting bias that are discussed in this article. Editors should implement quality-control processes aiming at preventing outcome reporting bias. Readers should be informed as to the efficiency of the implemented process.
已经发布了若干要求和规定,以通过试验的前瞻性注册、结果披露、获取提交给监管机构的试验报告以及获取匿名的患者层面数据来促进临床试验透明度。临床试验结果通过文章进行传播。然而,许多报告存在结果报告偏倚。开放获取试验数据将有助于遏制结果报告偏倚。然而,这对临床医生来说还不够。事实证明,期刊工作人员获取试验方案在防止结果报告偏倚方面相当无效。本文讨论了为解决结果报告偏倚而提出或实施的两项提议。编辑应实施旨在防止结果报告偏倚的质量控制流程。应向读者告知所实施流程的有效性。