Adequate information about clinical trial results must be given to participants

Adequate information about clinical trial results must be given to participants

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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. Access through your institution Buy or subscribe This is a preview of subscription content, access via your institution ACCESS OPTIONS Access through your institution Access Nature and 54 other Nature Portfolio journals Get Nature+, our best-value online-access subscription $29.99 / 30 days cancel any time Learn more Subscribe to this journal Receive 12 print issues and online access $209.00 per year only $17.42 per issue Learn more Buy this article * Purchase on SpringerLink * Instant access to full article PDF Buy now Prices may be subject to local taxes which are calculated during checkout ADDITIONAL ACCESS OPTIONS: * Log in * Learn about institutional subscriptions * Read our FAQs * Contact customer support REFERENCES * Raza, M. Z., Bruhn, H. & Gillies, K. _BMJ Open_ 10, e035730 (2020). Article  PubMed  PubMed Central  Google Scholar  * Long, C. R. et al. _Clin. Trials_ 13, 582–591 (2016). Article  PubMed  PubMed Central  Google Scholar  * Schroter, S., Price, A., Malički, M., Richards, T. & Clarke, M. _BMJ Open_ 9, e032701 (2019). Article  PubMed  PubMed Central  Google Scholar  * 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 * Sgro, G. M., Maurer, M., Nguyen, B. & Siegel, J. E. _Contemp. Clin. Trials_ 33, 101136 (2023). Article  Google Scholar  * Bruhn, H. et al. _BMJ Open_ 12, e057019 (2022). Article  PubMed  PubMed Central  Google Scholar  * Heerman, W. J., Wilkins, C. H. & Barkin, S. L. _Ped. Res._ 89, 714–715 (2021). Article  Google Scholar  * Zannad, F. et al. _Eur. Heart J._ 44, 4220–4229 (2023). Article  PubMed  Google Scholar  * Shiely, F. & Daly, A. _J. Clin. Epidemiol._ 156, 105–112 (2023). Article  PubMed  Google Scholar  * Bjorklund, M., Shiely, F. & Gillies, K. _PLoS One_ 17, e0268898 (2022). Article  PubMed  PubMed Central  CAS  Google Scholar  * Dal-Ré, R., Voo, T. C. & Holm, S. _J. Glob. Health_ 13, 06019 (2023). Article  PubMed  PubMed Central  Google Scholar  * Nelson, J. T., Tse, T., Puplampu-Dove, Y., Golfinopoulos, E. & Zarin, D. A. _J. Am. Med. Assoc._ 329, 1404–1406 (2023). * Bruhn, H. et al. _Trials_ 22, 361 (2021). Article  PubMed  PubMed Central  Google Scholar  * South, A. et al. _PLoS Med._ 18, e1003798 (2021). Article  PubMed  PubMed Central  Google Scholar  * Bai, A. D. et al. _JAMA Netw. Open_ 6, e2253301 (2023). Article  PubMed  Google Scholar  * 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 * Epidemiology Unit, Health Research Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Madrid, Spain Rafael Dal-Ré * Division of Medical Ethics, School of Medicine, NYU Langone Medical Center, New York, NY, USA Arthur L. Caplan * Centre for Social Ethics and Policy, Department of Law, School of Social Sciences, University of Manchester, Manchester, UK Søren Holm * Centre for Medical Ethics, HELSAM, Faculty of Medicine, University of Oslo, Oslo, Norway Søren Holm * Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK Reecha Sofat * BHF Data Science Centre, Health Data Research, London, UK Reecha Sofat * National Cancer Research Institute Advocates Forum, Stevenage, UK Richard Stephens Authors * Rafael Dal-Ré View author publications You can also search for this author inPubMed Google Scholar * Arthur L. Caplan View author publications You can also search for this author inPubMed Google Scholar * Søren Holm View author publications You can also search for this author inPubMed Google Scholar * Reecha Sofat View author publications You can also search for this author inPubMed Google Scholar * Richard Stephens View author publications You can also search for this author inPubMed Google Scholar 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 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_ 30, 2404–2406 (2024). https://doi.org/10.1038/s41591-024-02948-1 Download citation * Published: 08 May 2024 * Issue Date: September 2024 * DOI: https://doi.org/10.1038/s41591-024-02948-1 SHARE THIS ARTICLE Anyone you share the following link with will be able to read this content: Get shareable link Sorry, a shareable link is not currently available for this article. Copy to clipboard Provided by the Springer Nature SharedIt content-sharing initiative

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.


Access through your institution Buy or subscribe This is a preview of subscription content, access via your institution ACCESS OPTIONS Access through your institution Access Nature and 54


other Nature Portfolio journals Get Nature+, our best-value online-access subscription $29.99 / 30 days cancel any time Learn more Subscribe to this journal Receive 12 print issues and


online access $209.00 per year only $17.42 per issue Learn more Buy this article * Purchase on SpringerLink * Instant access to full article PDF Buy now Prices may be subject to local taxes


which are calculated during checkout ADDITIONAL ACCESS OPTIONS: * Log in * Learn about institutional subscriptions * Read our FAQs * Contact customer support REFERENCES * Raza, M. Z., Bruhn,


H. & Gillies, K. _BMJ Open_ 10, e035730 (2020). Article  PubMed  PubMed Central  Google Scholar  * Long, C. R. et al. _Clin. Trials_ 13, 582–591 (2016). Article  PubMed  PubMed Central


  Google Scholar  * Schroter, S., Price, A., Malički, M., Richards, T. & Clarke, M. _BMJ Open_ 9, e032701 (2019). Article  PubMed  PubMed Central  Google Scholar  * 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 * Sgro, G. M., Maurer, M., Nguyen, B. & Siegel, J. E. _Contemp. Clin. Trials_ 33,


101136 (2023). Article  Google Scholar  * Bruhn, H. et al. _BMJ Open_ 12, e057019 (2022). Article  PubMed  PubMed Central  Google Scholar  * Heerman, W. J., Wilkins, C. H. & Barkin, S.


L. _Ped. Res._ 89, 714–715 (2021). Article  Google Scholar  * Zannad, F. et al. _Eur. Heart J._ 44, 4220–4229 (2023). Article  PubMed  Google Scholar  * Shiely, F. & Daly, A. _J. Clin.


Epidemiol._ 156, 105–112 (2023). Article  PubMed  Google Scholar  * Bjorklund, M., Shiely, F. & Gillies, K. _PLoS One_ 17, e0268898 (2022). Article  PubMed  PubMed Central  CAS  Google


Scholar  * Dal-Ré, R., Voo, T. C. & Holm, S. _J. Glob. Health_ 13, 06019 (2023). Article  PubMed  PubMed Central  Google Scholar  * Nelson, J. T., Tse, T., Puplampu-Dove, Y.,


Golfinopoulos, E. & Zarin, D. A. _J. Am. Med. Assoc._ 329, 1404–1406 (2023). * Bruhn, H. et al. _Trials_ 22, 361 (2021). Article  PubMed  PubMed Central  Google Scholar  * South, A. et


al. _PLoS Med._ 18, e1003798 (2021). Article  PubMed  PubMed Central  Google Scholar  * Bai, A. D. et al. _JAMA Netw. Open_ 6, e2253301 (2023). Article  PubMed  Google Scholar  * 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 * Epidemiology Unit, Health Research


Institute-Fundación Jiménez Díaz University Hospital, Universidad Autónoma de Madrid, Madrid, Spain Rafael Dal-Ré * Division of Medical Ethics, School of Medicine, NYU Langone Medical


Center, New York, NY, USA Arthur L. Caplan * Centre for Social Ethics and Policy, Department of Law, School of Social Sciences, University of Manchester, Manchester, UK Søren Holm * Centre


for Medical Ethics, HELSAM, Faculty of Medicine, University of Oslo, Oslo, Norway Søren Holm * Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK Reecha


Sofat * BHF Data Science Centre, Health Data Research, London, UK Reecha Sofat * National Cancer Research Institute Advocates Forum, Stevenage, UK Richard Stephens Authors * Rafael Dal-Ré


View author publications You can also search for this author inPubMed Google Scholar * Arthur L. Caplan View author publications You can also search for this author inPubMed Google Scholar *


Søren Holm View author publications You can also search for this author inPubMed Google Scholar * Reecha Sofat View author publications You can also search for this author inPubMed Google


Scholar * Richard Stephens View author publications You can also search for this author inPubMed Google Scholar 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 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_ 30, 2404–2406 (2024). https://doi.org/10.1038/s41591-024-02948-1 Download citation *


Published: 08 May 2024 * Issue Date: September 2024 * DOI: https://doi.org/10.1038/s41591-024-02948-1 SHARE THIS ARTICLE Anyone you share the following link with will be able to read this


content: Get shareable link Sorry, a shareable link is not currently available for this article. Copy to clipboard Provided by the Springer Nature SharedIt content-sharing initiative