4.6 Article

Investigators' sense of failure thwarted transparency in clinical trials discontinued for poor recruitment

期刊

JOURNAL OF CLINICAL EPIDEMIOLOGY
卷 145, 期 -, 页码 136-143

出版社

ELSEVIER SCIENCE INC
DOI: 10.1016/j.jclinepi.2022.01.024

关键词

Randomized controlled trials; Trial discontinuation; Participant recruitment; Transparency; Trial stakeholders; Implications; Qualitative research

资金

  1. Swiss National Science Foundation [320030_149496/1]
  2. Research Fund of the University of Basel
  3. Kaethe-Zingg-Schwichtenberg Foundation
  4. Swiss National Science Foundation (SNF) [320030_149496] Funding Source: Swiss National Science Foundation (SNF)

向作者/读者索取更多资源

When a clinical trial is prematurely discontinued, stakeholders need to take appropriate actions to maintain trust in clinical research and learn from the experience. However, barriers to transparency continue to exist, with many investigators failing to notify stakeholders or publish the trial's results. Investigators' sense of failure and associated negative emotions were identified as key reasons for this lack of transparency.
Background and Objective: 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. Methods: 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. Results: 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. Conclusion: 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. (c) 2022 The Author(s). Published by Elsevier Inc.

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