Participants are very keen to understand the outcomes of the research they were involved in, but they commonly report that weren’t shared with them. While there may be logistical challenges for sponsors in sharing these results (particularly for pharmaceutical companies testing new medications), this is widely recognised as an important way to demonstrate respect for the research participants.
Considerations
- Generally, sponsors are responsible for communicating trial outcomes with trial sites, who are then responsible for the contact with trial participants. As such, sponsors are encouraged to maintain relationships with site Primary Investigators until the summary of results are ready for ethics review and distribution, or to develop a plan to communicate these results to participants after they have closed the site.
- Equally, ethics review bodies should question sponsors about their dissemination plans if they seek to close their study before they have submitted a plain language summary for their review.
- Research projects that are testing therapeutic goods need to be aware of Australian therapeutic goods law and regulations in how they frame and distribute research outcomes to avoid promoting unregulated therapeutic goods.
Participant experience
- Most workshop participants reported that they had never received information about the outcomes of the research, even if these had been promised.
- Sharing the research outcomes was consistently seen as a way of demonstrating respect to the participants.
- Any type of communication - doesn't matter how little it is - about the outcomes of the study is amazing and phenomenal. Just to know that the study is taking the next step, or we've developed data, or we have some outcomes. The bare minimum would be fantastic.
- If people want information at the end of the trial when you offer it during the trial, then you need to step up to the mark and actually do what you say you're going to do.
- To be able to share a short video about the trial with family and friends would be great, because sometimes it can be quite difficult to explain what you're involved in.
- When you are a research participant, knowing and understanding that you have actually contributed to finding an answer to a problem is really powerful: it had a conclusion, and you know what the result was.
Suggestions
- Set expectations on what type of outcomes or results will be shared, and when they are likely to be available
- Having layered information will increase the accessibility of the results. This could be by having a plain language dot point summary followed by more detail or sharing publications on request.
- Negative results or future research on the topic are also useful for participants to know.
- Have the option for the information to be in a format participants can share with their care team (e.g.: something they can download and print out). This will also increase the translational impact of the study.
Resources and case studies
- Multiregional Clinical Trials (USA) has a Return of Aggregate Results Toolkit. The toolkit includes a template and useful guidance on plain language terminology (e.g. for describing endpoints).
- The EU has mandated that all trials produce plain language summaries within one year of closing.
- Useful guidance: PLS of Publications Toolkit - Envision the Patient
- Case study from UK: Communicating the ICON8 results to participants | MRC Clinical Trials Unit at UCL
- TransCelerate (USA) has recommendations for using non-promotional language in lay summaries: TransCelerate-Non-Promotional-Language-Guidelines-v10.2.pdf (transceleratebiopharmainc.com)
- UK paper evaluating the cost of providing plain language summaries: Site staff perspectives on communicating trial results to participants: Cost and feasibility results from the Show RESPECT cluster randomised, factorial, mixed-methods trial
