BACKGROUND
The timely dissemination of the outcomes from research projects is a key step to maximising the benefits from clinical research. However, outcomes are often not shared with all of the relevant interest holders. There are existing requirements for research dissemination in clinical research, but these do not provide consistent expectations for when, with whom, and how outcomes should be shared.
- The Australian Responsible Code of Research and the supporting Publication and Dissemination of Research Guide requires that publicly funded research be responsibly disseminated to “the widest appropriate audience in forms that are accessible to that audience” (section 4.8).
- The National Statement of Ethical Conduct in Human Research encourages researchers to consider the risks and benefits of how they disseminate their research findings both to participants (Element 5) and the general public (Element 6), while stating that this dissemination is consistent with the ethical principles of respect, beneficence and justice.
- ICH E6(R3) requires sponsors to make the trial results publicly available, in accordance with applicable regulatory requirements (3.17.2).
SCOPE
This project will synthesise, raise awareness of, and develop practical tools to facilitate post-trial research dissemination and related activities in Australia. It will focus on strategies for sharing the outcomes of research projects with other researchers, clinicians, HRECs, and participants, including practical tools and resources to promote and facilitate:
- The dissemination of research results through clinical trial registries. This could include a myth-busting component (e.g. improving awareness that reporting on registries does not count as prior publication) and strategies to strengthen the role of research funders, ethics committees and other potential regulators in this space. A useful starting point for this is a recent article by Kaul et al (2025) which reviews dissemination via the ANZCTR among other WHO-accredited registries. The project could potentially develop guidance and resources that feed into future National One Stop Shop systems.
- Publishing lay summaries and sharing individual and/or aggregate results with participants.
- Guidance for sponsors and researchers on writing and disseminating lay summaries, including the use of AI/LLMs in developing lay summaries.
- Recognition of research participants as warranting dedicated attention when it comes to research dissemination, including exploring the opportunities to track and measure the impact of communicating results and existing barriers and available levers
- Specific consideration of more challenging issues e.g.—unblinding participants, provision of individual results, provision of negative trial results, providing results to next-of-kin.
An additional related issue is considerations for post-trial care and follow-up. Post-trial care is especially relevant in the context of implantable devices, which may require explantation post-trial. Ongoing follow up of trials after site close-out can also provide more definitive information on effectiveness and safety.
OUTPUTS
This project will develop practical tools and resources for researchers, sponsors and others on satisfying their dissemination post-trial responsibilities including:
- Regulatory considerations
- Ethical considerations
- Practical considerations
- Consumer perspectives