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  • Perspective
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How to make cardiology clinical trials more inclusive

Nature Medicine volume 30, pages 2745–2755 (2024)Cite this article

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Abstract

Cardiovascular clinical trials continue to under-represent children, older adults, females and people from ethnic minority groups relative to population disease distribution. Here we describe strategies to foster trial representativeness, with proposed actions at the levels of trial funding, design, conduct and dissemination. In particular, trial representativeness may be increased through broad recruitment strategies and site selection criteria that reflect the diversity of patients in the catchment area, as well as limiting unjustified exclusion criteria and using pragmatic designs that minimize research burden on patients (including embedded and decentralized trials). Trial communications ought to be culturally appropriate; engaging diverse people with lived experience in the co-design of some trial elements may foster this. The demographics of trialists themselves are associated with participant demographics; therefore, trial leadership must be actively diversified. Funding bodies and journals increasingly require the reporting of sociodemographic characteristics of trial participants, and regulatory bodies now provide guidance on increasing trial diversity; these steps may increase the momentum towards change. Although this Perspective focuses on the cardiovascular trial context, many of these strategies could be applied to other fields.

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Fig. 1: Summary of the evidence generation process.
Fig. 2: Broadening the recruitment pool with registry-based RCTs.
Fig. 3: Using adaptive trial designs to increase representativeness.
Fig. 4: Strategies to improve representativeness in cardiovascular clinical trials.

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Acknowledgements

This article was generated from discussions during a Cardiovascular Round Table (CRT) event organized in July 2023 by the ESC. The ESC CRT is a strategic forum for high-level dialogue between 20 industry companies (pharmaceuticals, devices and diagnostics) and the ESC leadership to identify and discuss key strategic issues for the future of cardiovascular health in Europe. We alone are responsible for the views expressed in this manuscript, which do not necessarily represent the views or policies of the institutions to which we are affiliated. We thank P. Lavigne and S. Portelance (unaffiliated; supported by the ESC) for contributions to the manuscript. This report was funded as part of the work of the CRT. The CRT is funded thanks to multi-sponsorship. Learn more at https://www.escardio.org/The-ESC/What-we-do/Cardiovascular-Round-Table-(CRT).

Author information

Authors and Affiliations

  1. Université de Lorraine, Inserm Clinical Investigation Center at Institut Lorrain du Coeur et des Vaisseaux, Nancy, France

    Faiez Zannad

  2. University Hospital of Nancy, Nancy, France

    Faiez Zannad

  3. George Institute for Global Health UK, London, UK

    Otavio Berwanger

  4. Imperial College London, London, UK

    Otavio Berwanger

  5. Bayer Consumer Care, Basel, Switzerland

    Stefano Corda

  6. Division of Cardiovascular Sciences, Faculty of Life Sciences and Medicine, King’s College London, London, UK

    Martin R. Cowie

  7. Cardiology A Department, Fattouma Bourguiba University Hospital, University of Monastir, Monastir, Tunisia

    Habib Gamra

  8. Baim Institute for Clinical Research, Harvard Medical School, Boston, MA, USA

    C. Michael Gibson & Harriette G. C. Van Spall

  9. Bristol Myers Squibb, Cambridge, MA, USA

    Alexandra Goncalves

  10. University of Porto Medical School, Porto, Portugal

    Alexandra Goncalves

  11. Global Development, Amgen, Thousand Oaks, CA, USA

    Thomas Hucko

  12. Leicester Diabetes Centre, University of Leicester, Leicester, UK

    Kamlesh Khunti

  13. Bristol Heart Institute, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK

    Maciej Kostrubiec

  14. Department of Internal Medicine and Cardiology, The Medical University of Warsaw, Warsaw, Poland

    Maciej Kostrubiec

  15. Medical Affairs, Boehringer Ingelheim International, Ingelheim, Germany

    Bettina Johanna Kraus

  16. Department of Internal Medicine I, University Hospital Würzburg, Würzburg, Germany

    Bettina Johanna Kraus

  17. Division of Cardiology, Department of Medicine, Karolinska Institutet and Karolinska Universitetssjukhuset, Stockholm, Sweden

    Cecilia Linde

  18. Royal Brompton and Harefield Hospitals, Imperial College London and King’s College London, London, UK

    Thomas F. Lüscher

  19. Center for Molecular Cardiology, University of Zurich, Zurich, Switzerland

    Thomas F. Lüscher

  20. Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK

    Marion Mafham

  21. European Society of Cardiology Patient Forum, London, UK

    Richard Mindham

  22. Women as One, Severna Park, MD, USA

    Rebecca F. Ortega

  23. Bispebjerg and Frederiksberg University Hospital, Copenhagen, Denmark

    Eva Prescott

  24. Research Institute of St. Joseph’s, St. Joseph’s Healthcare, Hamilton, Ontario, Canada

    Lehana Thabane & Harriette G. C. Van Spall

  25. Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada

    Lehana Thabane & Harriette G. C. Van Spall

  26. Department of Internal Medicine, Division of Cardiology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA

    Clyde Yancy

  27. Cardiovascular Diseases, Roche Diagnostics, Rotkreuz, Switzerland

    André Ziegler

  28. Department of Medicine, Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada

    Harriette G. C. Van Spall

  29. Population Health Research Institute, Hamilton, Ontario, Canada

    Harriette G. C. Van Spall

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  1. Faiez Zannad
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  2. Otavio Berwanger
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Corresponding author

Correspondence to Faiez Zannad.

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Competing interests

F.Z. has received consulting fees from 89bio, Applied Therapeutics, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Cardior Pharmaceuticals, CellProthera, Cereno Scientific, CEVA, CVRx, Merck, Novartis, Novo Nordisk, Owkin, Pfizer and Servier, honoraria for lectures from Bayer, Boehringer Ingelheim, CEVA, CVRx, Merck and Novartis and fees for participating on a data safety monitoring board or advisory board from Acceleron/Merck and has equity interests in G3 Pharmaceuticals, Cereno Scientific, CardioRenal, Eshmoun Clinical Research and CVCT. O.B. has received grants or contracts from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Novartis, Pfizer and Servier and travel and/or meeting attendance support from AstraZeneca and Servier. S.C. has been employed by Bayer. M.R.C. has been employed by and has stock options in AstraZeneca. H.G. has received honoraria from Menarini and Servier for lectures, participated on a data safety monitoring board for the RIC Africa trial and held a leadership role (Vice President) for the Pan-African Society of Cardiology. A.G. has been employed by and has stock options in Bristol Myers Squibb. T.H. has been employed by, has stock or stock options in and has received travel and/or meeting attendance support from Amgen. K.K. has received institutional grants from Applied Therapeutics, AstraZeneca, Boehringer Ingelheim, Lilly, Merck Sharp & Dohme, Novo Nordisk, Oramed Pharmaceuticals, Sanofi-Aventis and Servier, consulting fees from Abbott, Amgen, Applied Therapeutics, AstraZeneca, Bayer, Boehringer Ingelheim, Lilly, Merck Sharp & Dohme, Napp, Novartis, Novo Nordisk, Oramed Pharmaceuticals, Roche, Sanofi-Aventis and Servier and travel and/or meeting attendance support from Abbott, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Lilly, Merck Sharp & Dohme, Napp, Novartis, Novo Nordisk, Roche, Sanofi-Aventis and Servier and has held leadership roles for the Centre for Ethnic Health Research (Director) and South Asian Health Foundation charity (Trustee and Working Group Chair). B.J.K. has been employed by and has received travel and/or meeting attendance support from Boehringer Ingelheim International. C.L. has received grants or contracts from the Swedish Heart Lung Foundation, Swedish Society of Science and Stockholm County Council, consulting fees from AstraZeneca and Medtronic and payment or honoraria for lectures, presentations or speaker bureaus form AstraZeneca, Bayer, Boehringer Ingelheim, Impulse Dynamics, Medtronic, Novartis and Vifor Pharma, has participated on a data safety monitoring board or advisory board for the ABC study by UCR Uppsala Sweden and has held a leadership role (Secretary Treasurer) for the ESC. T.F.L. has received institutional grants from Abbott, Amgen, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Menarini Foundation, Novartis, Novo Nordisk, Roche Diagnostics, Sanofi and Vifor and honoraria from Amgen, Dacadoo, Daiichi Sankyo, Menarini Foundation, Novartis, Novo Nordisk, Philips and Pfizer. M.M. has received research grants from Novartis, Novo Nordisk and Health Data Research UK and a fellowship from the British Heart Foundation and has participated on a data safety monitoring board or advisory board for the PAVE-2, STIMULATE-ICP, ASPECT, ORION-4 and ASCEND PLUS trials. R.M. has received travel and/or meeting attendance support from the ESC, Horizon and Digital Health for Heart Health. R.F.O. has held a leadership role (Executive Director) with Women as One. E.P. has held a leadership role (Committee Chair) for the ESC. C.Y. has been Steering Committee Chair for ACTIV trials, sponsored by the National Heart, Lung, and Blood Institute. A.Z. has been employed by and has stock or stock options in Roche Diagnostics. H.G.C.V.S. has received grants from the Canadian Institutes of Health Research and Heart and Stroke Foundation, education grants from Boehringer Ingelheim and Novartis and consulting fees from the Baim Institute for Clinical Research, Cardiovascular Research Foundation, Colorado Prevention Center Clinical Research and Medtronic. The remaining authors declare no competing interests.

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Nature Medicine thanks Yaling Han, Kevin Alexander and the other, anonymous, reviewer(s) for their contribution to the peer review of this work. Primary Handling Editor: Karen O’Leary, in collaboration with the Nature Medicine team.

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Zannad, F., Berwanger, O., Corda, S. et al. How to make cardiology clinical trials more inclusive. Nat Med 30, 2745–2755 (2024). https://doi.org/10.1038/s41591-024-03273-3

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