148 Reporting clinical trial findings as an ethical responsibility to research participants: a qualitative interview study
Why this work is in the frame
A frame that forgets how it found something cannot be audited. These are the routes that admitted this work.
Bibliographic record
Abstract
<h3>Objectives</h3> Approximately 40% of randomized controlled trials are not published. Advocates of full reporting of clinical trials have argued nonpublication betrays trial participants and violates an implicit contract between participants and researchers. However, trial participant views on the importance of reporting research findings and trial investigator views on the responsibility to report findings are unclear. We conducted a qualitative interview study to understand how the experiences and views of trial participants, trial investigators, and others relate to whether researchers have a duty to trial participants to report research findings. <h3>Method</h3> We conducted qualitative semi-structured interviews between March 2019 and April 2021 with participants in the Canadian provinces of Alberta, British Columbia, and Ontario. Participants eligible for an interview included clinical trial participants who had taken part in a trial while at least 18 years of age in the 5 years prior to the interview, clinical trial investigators and research coordinators with experience in drug research, research administrators with knowledge of policy and practice related to dissemination of clinical trial findings or relations with trial sponsors, and research ethics board members with at least 1 year of experience in ethics review of clinical trials. The study included 34 participants, including 10 clinical trial participants, 17 clinical trial investigators, 1 clinical research coordinator, 3 research administrators, and 3 research ethics board members. Analytic strategies were informed by grounded theory, including initial coding, focused coding, and memo-writing to develop key themes. <h3>Results</h3> Most clinical trial participants felt that reporting clinical trial results is important. Accounts of trial participants suggested their contributions are part of a reciprocal relationship involving the expectation that research will advance medical knowledge. One trial participant asked: “If we’re doing the work, spending the dollars and not using that information to further medical science, then what was the point of doing all that work in the first place?” Similarly, comments from trial investigators suggested that reporting trial results is part of reciprocity with trial participants and is a necessary part of honouring informed consent. Accounts of trial investigators suggested 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. <h3>Conclusions</h3> The views of trial participants, trial investigators, and others connected to clinical trial research in Canada suggested that researchers have an obligation to participants to report clinical trial results and that reporting results is necessary for honouring informed consent. Trial participants may consent to enter a trial with the understanding that research will benefit future patients. However, this consent is not respected when trial results are not reported and this potential benefit is not fulfilled. Research ethics boards could help ensure clinical trials are reported by auditing whether trials they have approved have been reported or by assisting research institutions to monitor and support reporting of clinical trials.
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Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.506 | 0.767 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.001 | 0.023 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it