Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Basel, Switzerland; Department of Public Health, Institute for Biomedical Ethics, University of Basel, Basel, Switzerland.
Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Basel, Switzerland; Institute of History and Ethics in Medicine, TUM School of Medicine, Technical University of Munich, Munich, Germany.
J Clin Epidemiol. 2022 May;145:136-143. doi: 10.1016/j.jclinepi.2022.01.024. Epub 2022 Feb 4.
When a randomized clinical trial (RCT) prematurely discontinues, it is essential that stakeholders do the right thing to ensure that lessons can be learnt and trust in clinical research is maintained. There is, however, a lack of evidence exploring this issue. This study aimed to examine clinical trial stakeholders' practices following trial discontinuation due to poor participant recruitment and their views on implications of such discontinuation.
Individual semi-structured qualitative interviews were conducted with 49 clinical trial stakeholders from Switzerland (n = 39), Germany (n = 9) and Canada (n = 1) between August 2015 and November 2016.
After interviews with 49 clinical trial stakeholders (75% male presenting), it was found that stakeholders were aware of the risks of premature trial discontinuation wasting limited resources, adversely impacting scientific evidence, and having negative personal and professional implications. However, barriers continue to undermine transparency regarding trial discontinuation in practice, with it being reported that most investigators of discontinued trials are failing to notify stakeholders or publishing their results. Investigators sense of failure and associated negative emotions were identified as a key reason why investigators are not more transparent following discontinuation.
The decision to notify stakeholders and publish results of a discontinued clinical trial should not rest solely on individual investigators but come from a systemic approach. However, until health research proactively requires the dissemination of results of all clinical trials, much will rest on individual investigators being motivated to do the right thing. Support programs might be helpful for investigators involved in discontinued trials and promote transparency and learning lessons.
当一项随机临床试验（RCT）提前终止时，利益相关者必须采取正确的措施，以确保可以吸取教训并维护对临床研究的信任。然而，目前缺乏探索这一问题的证据。本研究旨在探讨由于参与者招募不佳而导致临床试验提前终止后，临床试验利益相关者的实践以及他们对这种终止的影响的看法。
2015 年 8 月至 2016 年 11 月，瑞士（n=39）、德国（n=9）和加拿大（n=1）的 49 名临床试验利益相关者接受了个体半结构式定性访谈。
在对 49 名临床试验利益相关者（75%为男性）进行访谈后发现，利益相关者意识到提前终止试验会浪费有限的资源，对科学证据产生不利影响，并对个人和专业产生负面影响。然而，实践中仍然存在阻碍透明度的障碍，大多数终止试验的研究者未能通知利益相关者或公布其结果。研究者的失败感和相关的负面情绪被认为是研究者在终止后不更透明的一个关键原因。
通知利益相关者和公布终止的临床试验结果的决定不应仅取决于个别研究者，而应来自系统方法。然而，在卫生研究主动要求传播所有临床试验的结果之前，很大程度上取决于参与终止试验的个别研究者是否有动力做正确的事情。支持计划可能对参与终止试验的研究者有帮助，并促进透明度和吸取教训。
