Sharing clinical trial results with participants: important, expected and possible.

Abstract

Participants in clinical trials should be pro-actively offered the results of trials in which they have participated. This should be done in a way that is accessible and understandable for all participants. People who have taken part in research have a right to know the results of the studies in which they have taken part and should be given the option of receiving these results. Most trial participants want to receive the overall results. Key reasons for sharing results include respecting participants' contributions, enhancing their understanding of research benefits, increasing transparency, and potentially improving recruitment and retention. We propose 8 principles to guide sharing of results with trial participants:1. Trial teams should pro-actively offer overall study results to all clinical trial participants, irrespective of what the results show.2. Participants should be given the choice of whether to receive research results.3. Results should be offered to participants in a timely manner.4. Trial teams should manage participants' expectations around when the results will be available.5. Results should be offered in a way that is accessible to participants, both in terms of the communication mechanism and the content.6. Patient and public involvement is essential in sharing results with participants.7. Sharing results with participants requires resources.8. Consideration needs to be given to potential barriers/challenges to sharing results with participants from the planning stage of the study.