Public reporting of clinical trial findings as an ethical responsibility to participants: a qualitative study

Abstract

ObjectiveTo understand how the experiences and views of trial participants, trial investigators and others connected to clinical trial research relate to whether researchers have a duty to participants to publicly report research findings.DesignQualitative interview study.SettingSemistructured interviews held in person or by telephone between March 2019 and April 2021 with participants in the Canadian provinces of Alberta, British Columbia and Ontario.Participants34 participants, including 10 clinical trial participants, 17 clinical trial investigators, 1 clinical research coordinator, 3 research administrators and 3 research ethics board members.AnalysisWe conducted a thematic analysis, including qualitative coding of interview transcripts and identification of key themes.Main outcome measuresKey themes identified through qualitative coding of interview data.ResultsMost clinical trial participants felt that reporting clinical trial results is important. Accounts of trial participants suggest their contributions are part of a reciprocal relationship involving the expectation that research will advance medical knowledge. Similarly, comments from trial investigators suggest that reporting trial results is part of reciprocity with trial participants and is a necessary part of honouring informed consent. Accounts of trial investigators suggest that when drug trials are not reported, this may undermine informed consent in subsequent trials by withholding information on harms or efficacy relevant to informed decisions on whether to conduct or enroll in future trials of similar drugs.ConclusionThe views of trial participants, trial investigators and others connected to clinical trial research in Canada suggest that researchers have an obligation to participants to publicly report clinical trial results and that reporting results is necessary for honouring informed consent.

Center with or Without a Coordinator? The Coordinator as an Integral Part of a Research Team

“…Increasingly, trial participants are beginning to perceive a "mission" in contributing to the advancement of more effective treatments, underscoring their dedication to this cause. 18…”