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. 2025 Mar 27;26(1):107.
doi: 10.1186/s13063-025-08802-0.

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

Annabelle South  1 , Claire Bale  2 , Enhad Chowdhury  3 , Alexander Churchill  4 , Kim Donoghue  5 , Simon Grieveson  6 , Charlotte Hartley  7 , Catriona Manville  8 , Angela Polanco  9 , Kieran Prior  10 , Sheona Scales  11 , Kirstie Shearman  12 , Mahesh K B Parmar  7
Affiliations

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

Annabelle South et al. Trials. .

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.

Keywords: Communicating results; Feedback of results; Research ethics; Researcher-participant relations; Transparency; Trial conduct; Trial ethics.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: Not applicable. Consent for publication: Not applicable. Competing interests: CM is employed by the Association of Medical Research charities, the membership bodies of medical research charities. The unit MP directs has educational grant funds or support for medicines from the following companies: Novartis, Pfizer, ROCHE, ROCHE Products, Sanofi, Serum Institute of India, Shionogi, SUMVAX, Synteny Biotechnology, Takeda, Tibotec, Transgene, ViiV Healthcare, Virco Xenothera, CSL Behring, Eli-Lilly, Emergent Biosolutions, Gilead Sciences, GlaxoSmithKline, Grifols, ICON, Janssen Products LP, Janssen-Cilag, Janssen Pharmaceutica, Johnson & Johnson, Merck Serono, Micronoma, Modus Theraputics, MSD, Mylan, Abcodia Pvt Ltd, Advanced Accelerator – Applications International SA Akagera Amgen Aspirin Foundation, Astellas, AstraZeneca, AoA, Baxter, Bayer, BMS US Bri-Bio B&C Group, Cepheid, Cipla and Clovis Inc. AS is a trustee of the charity Picturing Health.

References

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    1. Health Research Authority. Make it public: transparency and openness in health and social care research. London: Health Research Authority; 2023. Available from: https://www.hra.nhs.uk/planning-and-improving-research/policies-standard.... Cited 05/03/25.
    1. Health Research Authority. Communicating study findings to participants: guidance: Health Research Authority; 2023 [Available from: https://www.hra.nhs.uk/planning-and-improving-research/policies-standard....

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