Borysowski Jan, Wnukiewicz-Kozłowska Agata, Górski Andrzej
Centre for Studies on Research Integrity, Institute of Law Studies, Polish Academy of Sciences, Warsaw, Poland.
Department of Clinical Immunology, Medical University of Warsaw, Warsaw, Poland.
Br J Clin Pharmacol. 2020 Apr;86(4):679-686. doi: 10.1111/bcp.14223. Epub 2020 Feb 19.
Timely and accurate dissemination of outcomes is essential to accomplish main benefits of scientific research including clinical trials. Clinical trial results can be disseminated in two main ways: by publication in a peer-reviewed journal and by posting on a publicly available clinical trial register. The credibility of the literature on clinical trials is significantly diminished because a high percentage of trials is not published. While current legal regulations both in the European Union (EU) and the USA impose a duty to submit summary results of clinical trials to a respective register (EU Clinical Trial Register and ClinicalTrials.gov, respectively), the compliance with this requirement has been generally inadequate. Trial outcomes can be also made accessible by data sharing. However, in spite of the wide promotion of this idea, the access of investigators to participant-level datasets remains limited. The main objective of this review is to discuss current legal regulations, international standards, ethical guidelines and recent policies pertaining to dissemination of clinical trial results.
及时、准确地传播研究成果对于实现包括临床试验在内的科学研究的主要益处至关重要。临床试验结果可以通过两种主要方式传播：在同行评审期刊上发表以及在公开可用的临床试验注册平台上发布。由于未发表的试验比例很高，关于临床试验的文献可信度显著降低。虽然欧盟（EU）和美国目前的法律法规都规定有义务将临床试验的总结结果提交到各自的注册平台（分别是欧盟临床试验注册平台和美国国立医学图书馆临床试验数据库），但对这一要求的遵守情况总体上并不理想。试验结果也可以通过数据共享来获取。然而，尽管这一理念得到了广泛推广，但研究人员对参与者层面数据集的访问仍然有限。本综述的主要目的是讨论与临床试验结果传播相关的现行法律法规、国际标准、伦理准则和近期政策。
