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

Richard L Morrow; Barbara Mintzes; Garry Gray; Michael R Law; Scott Garrison; Colin R Dormuth

doi:10.1136/bmjopen-2022-068221

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

BMJ Open. 2023 Mar 21;13(3):e068221. doi: 10.1136/bmjopen-2022-068221.

Authors

Richard L Morrow¹, Barbara Mintzes², Garry Gray³, Michael R Law⁴, Scott Garrison⁵, Colin R Dormuth⁶

Affiliations

¹ School of Population and Public Health, The University of British Columbia, Vancouver, British Columbia, Canada richard.morrow@ubc.ca.
² Faculty of Pharmacy and Charles Perkins Centre, University of Sydney Faculty of Health Sciences, The University of Sydney, New South Wales, Australia.
³ Department of Sociology, University of Victoria, Victoria, British Columbia, Canada.
⁴ Centre for Health Services and Policy Research, School of Population and Public Health, The University of British Columbia, Vancouver, British Columbia, Canada.
⁵ Family Medicine, University of Alberta, Edmonton, Alberta, Canada.
⁶ Anaesthesiology, Pharmacology, and Therapeutics, Therapeutics Initiative, The University of British Columbia, Vancouver, British Columbia, Canada.

Abstract

Objective: To 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.

Design: Qualitative interview study.

Setting: Semistructured 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.

Participants: 34 participants, including 10 clinical trial participants, 17 clinical trial investigators, 1 clinical research coordinator, 3 research administrators and 3 research ethics board members.

Analysis: We conducted a thematic analysis, including qualitative coding of interview transcripts and identification of key themes.

Main outcome measures: Key themes identified through qualitative coding of interview data.

Results: Most 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.

Conclusion: The 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.

Keywords: Clinical trials; ETHICS (see Medical Ethics); QUALITATIVE RESEARCH.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Alberta
Clinical Trials as Topic
Ethics, Research
Health Services Research*
Humans
Informed Consent*
Qualitative Research