Dissemination policy

Item 8: Plans to communicate trial results to participants, healthcare professionals, the public, and other relevant groups (e.g., reporting in trial registry, plain language summary, publication). 

Example

“The PI [principal investigator] and study team have developed a plan to promote dissemination and implementation of the study findings to consumer, clinical and payer stakeholders. The PAC [Patient Advisory Committee] will facilitate dissemination of the study and results to patient, advocate and community audiences. One key role the PAC will play is to develop and maintain relationships with local and regional organisations that may assist in disseminating the results. Presentations at local meetings (eg, grand rounds), at national meetings (eg, American Academy of Orthopaedic Surgeons) as well as publications in leading journals will be used to reach physicians more broadly. In addition, the team will convene an external advisory board made up of clinician, payer, researcher and consumer representatives to guide dissemination and implementation efforts. This group will convene for one in-person meeting and two calls over the study period. These external advisors are experts across different domains (clinical care, payers, patient advocacy and consumer groups) who can help disseminate study findings more broadly" [84]. 

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“We have registered the trial in ClinicalTrials.gov. After data collection is complete, and within two years of completion, we will report results in ClinicalTrials.gov, including a flow chart of study recruitment and dropout, demographic and baseline characteristics of participants, primary and secondary outcomes (adherence, CD4, viral load), statistical test results, and AE [adverse event] information if applicable. After complying with NIH reporting requirements in ClinicalTrials.gov, we will undertake multi-faceted dissemination to make results available to a range of stakeholder audiences, including: (1) meetings in Vietnam with public health officials at all levels, interested patients, and the HIV community; (2) peer-reviewed publications in HIV, social science, and policy and health systems journals; and (3) presentations at national and international conferences, including the International Association of Providers of AIDS Care (IAPAC)’s annual International Adherence Conference. In the preparation of abstracts and publications, we will follow the criteria for authorship recommended by the International Committee of Medical Journal Editors (ICMJE); we do not intend to employ professional writers. If findings indicate, we will work with partners in Vietnam to plan a larger effectiveness study" [111].

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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]. 

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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]

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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]. 

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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