Skip to main content

Thank you for visiting nature.com. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

  • Comment
  • Published:

Adequate information about clinical trial results must be given to participants

The lay summary of trial results to be provided to participants should be written in plain language, use infographics and be concise — something that currently is almost never achieved.

This is a preview of subscription content, access via your institution

Access options

Buy this article

Prices may be subject to local taxes which are calculated during checkout

References

  1. Raza, M. Z., Bruhn, H. & Gillies, K. BMJ Open 10, e035730 (2020).

    Article  PubMed  PubMed Central  Google Scholar 

  2. Long, C. R. et al. Clin. Trials 13, 582–591 (2016).

    Article  PubMed  PubMed Central  Google Scholar 

  3. Schroter, S., Price, A., Malički, M., Richards, T. & Clarke, M. BMJ Open 9, e032701 (2019).

    Article  PubMed  PubMed Central  Google Scholar 

  4. National Health and Medical Research Council. National Statement on Ethical Conduct in Human Research 2023 (Australian Government, 2024); https://www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2023

  5. Sgro, G. M., Maurer, M., Nguyen, B. & Siegel, J. E. Contemp. Clin. Trials 33, 101136 (2023).

    Article  Google Scholar 

  6. Bruhn, H. et al. BMJ Open 12, e057019 (2022).

    Article  PubMed  PubMed Central  Google Scholar 

  7. Heerman, W. J., Wilkins, C. H. & Barkin, S. L. Ped. Res. 89, 714–715 (2021).

    Article  Google Scholar 

  8. Zannad, F. et al. Eur. Heart J. 44, 4220–4229 (2023).

    Article  PubMed  Google Scholar 

  9. Shiely, F. & Daly, A. J. Clin. Epidemiol. 156, 105–112 (2023).

    Article  PubMed  Google Scholar 

  10. Bjorklund, M., Shiely, F. & Gillies, K. PLoS One 17, e0268898 (2022).

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  11. Dal-Ré, R., Voo, T. C. & Holm, S. J. Glob. Health 13, 06019 (2023).

    Article  PubMed  PubMed Central  Google Scholar 

  12. Nelson, J. T., Tse, T., Puplampu-Dove, Y., Golfinopoulos, E. & Zarin, D. A. J. Am. Med. Assoc. 329, 1404–1406 (2023).

  13. Bruhn, H. et al. Trials 22, 361 (2021).

    Article  PubMed  PubMed Central  Google Scholar 

  14. South, A. et al. PLoS Med. 18, e1003798 (2021).

    Article  PubMed  PubMed Central  Google Scholar 

  15. Bai, A. D. et al. JAMA Netw. Open 6, e2253301 (2023).

    Article  PubMed  Google Scholar 

  16. Tatsioni, A. et al. Ann. Intern. Med. 171, 300–301 (2019).

    Article  PubMed  Google Scholar 

Download references

Acknowledgements

The authors thank four British patient advocates, E. Banks, D. Keatley, M. Mackenzie and A. Roberts, for helpful comments on an earlier draft of this manuscript.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Rafael Dal-Ré.

Ethics declarations

Competing interests

The authors declare no competing interests.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Dal-Ré, R., Caplan, A.L., Holm, S. et al. Adequate information about clinical trial results must be given to participants. Nat Med (2024). https://doi.org/10.1038/s41591-024-02948-1

Download citation

  • Published:

  • DOI: https://doi.org/10.1038/s41591-024-02948-1

Search

Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing