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Nature medicine
Oct, 2024;30 (10): 2745-2755.

How to make cardiology clinical trials more inclusive.

Faiez Zannad, Otavio Berwanger, Stefano Corda, Martin R Cowie, Habib Gamra, C Michael Gibson, Alexandra Goncalves, Thomas Hucko, Kamlesh Khunti, Maciej Kostrubiec, Bettina Johanna Kraus, Cecilia Linde, Thomas F Lüscher, Marion Mafham, Richard Mindham, Rebecca F Ortega, Eva Prescott, Lehana Thabane, Clyde Yancy, André Ziegler, Harriette G C Van Spall
Author Information
  1. Faiez Zannad: Université de Lorraine, Inserm Clinical Investigation Center at Institut Lorrain du Coeur et des Vaisseaux, Nancy, France. f.zannad@chru-nancy.fr. ORCID
  2. Otavio Berwanger: George Institute for Global Health UK, London, UK.
  3. Stefano Corda: Bayer Consumer Care, Basel, Switzerland.
  4. Martin R Cowie: Division of Cardiovascular Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.
  5. Habib Gamra: Cardiology A Department, Fattouma Bourguiba University Hospital, University of Monastir, Monastir, Tunisia.
  6. C Michael Gibson: Baim Institute for Clinical Research, Harvard Medical School, Boston, MA, USA. ORCID
  7. Alexandra Goncalves: Bristol Myers Squibb, Cambridge, MA, USA.
  8. Thomas Hucko: Global Development, Amgen, Thousand Oaks, CA, USA.
  9. Kamlesh Khunti: Leicester Diabetes Centre, University of Leicester, Leicester, UK.
  10. Maciej Kostrubiec: Bristol Heart Institute, University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, UK. ORCID
  11. Bettina Johanna Kraus: Medical Affairs, Boehringer Ingelheim International, Ingelheim, Germany. ORCID
  12. Cecilia Linde: Division of Cardiology, Department of Medicine, Karolinska Institutet and Karolinska Universitetssjukhuset, Stockholm, Sweden. ORCID
  13. Thomas F Lüscher: Royal Brompton and Harefield Hospitals, Imperial College London and King's College London, London, UK. ORCID
  14. Marion Mafham: Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
  15. Richard Mindham: European Society of Cardiology Patient Forum, London, UK. ORCID
  16. Rebecca F Ortega: Women as One, Severna Park, MD, USA.
  17. Eva Prescott: Bispebjerg and Frederiksberg University Hospital, Copenhagen, Denmark.
  18. Lehana Thabane: Research Institute of St. Joseph's, St. Joseph's Healthcare, Hamilton, Ontario, Canada.
  19. Clyde Yancy: Department of Internal Medicine, Division of Cardiology, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
  20. André Ziegler: Cardiovascular Diseases, Roche Diagnostics, Rotkreuz, Switzerland. ORCID
  21. Harriette G C Van Spall: Baim Institute for Clinical Research, Harvard Medical School, Boston, MA, USA. ORCID
PMID: 39402268 DOI: 10.1038/s41591-024-03273-3

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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MeSH Term

Humans
Clinical Trials as Topic
Patient Selection
Cardiology
Female
Cardiovascular Diseases
Research Design
Male
Cultural Diversity
Journal Article Review
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