Explanation

A fundamental ethical principle in clinical trials is that the potential risks incurred by study participants should be balanced by the benefit of contributing to publicly available knowledge and future patients. Journal publication remains a key means of reporting trial results. Open access publishing provides patients, the public, and other interested parties with immediate and free access to read the trial’s results, with reduced copyright barriers.

Unfortunately, a high proportion of clinical trials remain unpublished.(112, 113) Despite providing important information relevant to patients, trials with statistically non-significant results are more prone to non-publication(114) and a long delay to publication (when published)(114-116)—often referred to as publication bias. Overall, the medical literature represents a biased subset of existing data, potentially leading to overestimation of benefits, underestimation of harms, and a detrimental impact on patient care and research.(112, 117, 118) Although peer reviewers and journal editors can be biased in favour of positive findings,(119) lack of publication appears to be primarily due to trial investigators or sponsors failing to submit “negative” or null results, rather than journals rejecting them.(114, 120)

Beyond journal publication, trial registries and preprint servers are important venues for dissemination.(121-123) Meta-research studies have found that over a quarter of unpublished trials in various countries had results available in trial registries, and some data (particularly harms) were more completely reported in registries than journal publications.(113, 124-127) Almost all journals are supportive of pre-printing trial protocols and completed studies (128) prior to formal journal submission.(129-131) Initial data suggest that there are few differences between trial results on preprint servers and final publication.(132-134) “Registered Reports” is another publication format that involves registration, peer review, and (possibly) pre-acceptance of a trial prior to data collection.(135)

Dissemination of trial results is closely linked to authorship. Substantive contributions to the design, conduct, interpretation, and reporting of a clinical trial are recognised through the granting of authorship on the final trial report.(43) Individuals who fulfil authorship criteria should not remain hidden (ghost authorship) and should have final authority over manuscript content. Similarly, those who do not fulfil such criteria should not be granted guest authorship.

Trials would not be possible without the voluntary contributions of participants. Communication of the trial results directly to the trial participants is widely considered an ethical responsibility supported by both researchers and participants.(136) A plain language summary of results for the wider public also serves to increase public knowledge and inform future patients.(137)

In a sample of 326 protocols approved in 2012, 70 (21%) trials remained unpublished after 10 years.(113) Twenty-three of 147 investigator-sponsored trials (16%) reported their results in a trial registry in contrast to 150 of 179 industry-sponsored trials (84%). Also, publication of trial results was associated with higher quality reporting in the protocol.(113) In two other samples of 108 and 292 protocols from 2016, plans to disseminate trial results were described in 56% and 71% of protocols, respectively.(9, 10)

The trial protocol should report the dissemination plan for the trial findings, including posting of trial results in a registry and publication in a journal. It is also important to describe how results will be conveyed to trial participants and broader audiences. The plan should include a process and timeframe for approving and submitting reports for dissemination, as well as authorship criteria.

Summary of key elements to address

● Plan to disseminate trial results to participants, healthcare professionals, the public, and other relevant groups (e.g., reporting results in trial registry, preprint, plain language summary, publication in an open access journal)

● Process and timeframe for approving and submitting reports for dissemination

● Authorship guidelines