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Recommendations to promote equity, diversity and inclusion in decentralized clinical trials

Nature Medicine volume 30, pages 3075–3084 (2024)Cite this article

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Abstract

Decentralized clinical trials involving the use of digital tools to facilitate remote research are gaining momentum. Rapid advancements in digital technologies have supported the adoption of these trials. These innovations facilitate virtual interactions between clinical trial teams and participants by making it easier to collect, transfer and store electronic data. While some studies have demonstrated the potential for these approaches to reduce barriers to clinical trial participation, they are associated with several challenges that may create or worsen existing health inequalities and limit the generalizability of trial results. Here we review the potential for digitally enabled and decentralized clinical trials to enhance clinical trial participation in an equitable manner. We describe the key barriers individuals from underserved groups may face, and provide recommendations to promote equity, diversity and inclusion.

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Fig. 1: Frequency of DCTs over time.
Fig. 2: Potential components of digitally enabled and decentralized trials.

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Acknowledgements

We thank M. K. ElZarrad, director of the Office of Medical Policy at the Center for Drug Evaluation and Research of the US Food and Drug Administration (FDA), who presented the FDA’s perspectives on DCTs at the workshop and provided valuable suggestions during the drafting of the manuscript. The views expressed in this publication are those of the authors and may not represent the views of the National Institute for Health and Care Research (NIHR), Medicines and Healthcare products Regulatory Agency, US FDA and Health Canada. This work was funded by Merck Healthcare. The funder, Merck, and the study sponsor, University of Birmingham, had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; or decision to submit the manuscript for publication. Several authors are employees of the University of Birmingham. However, beyond the declared author contributions, the sponsor had no additional role. B.M.-O.’s involvement in this piece of work is in a personal capacity and is not as a representative of the Health Research Authority.

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Authors and Affiliations

  1. Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK

    Olalekan Lee Aiyegbusi, Samantha Cruz Rivera, Nicola Anderson, Philip Collis, Sarah E. Hughes, Christel McMullan, Ravinder Verdi, Roger Wilson & Melanie J. Calvert

  2. National Institute for Health and Care Research Birmingham Biomedical Research Centre, University of Birmingham, Birmingham, UK

    Olalekan Lee Aiyegbusi, Nicola Anderson, Alastair K. Denniston, Sarah E. Hughes, Dipak Kotecha, Xiaoxuan Liu & Melanie J. Calvert

  3. National Institute for Health and Care Research Applied Research Collaboration West Midlands, University of Birmingham, Birmingham, UK

    Olalekan Lee Aiyegbusi, Nicola Anderson, Sarah E. Hughes & Melanie J. Calvert

  4. National Institute for Health and Care Research Blood and Transplant Research Unit in Precision Transplant and Cellular Therapeutics, University of Birmingham, Birmingham, UK

    Olalekan Lee Aiyegbusi, Sarah E. Hughes, Christel McMullan & Melanie J. Calvert

  5. Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK

    Olalekan Lee Aiyegbusi, Samantha Cruz Rivera, Alastair K. Denniston, Xiaoxuan Liu & Melanie J. Calvert

  6. Merck, Darmstadt, Germany

    Paul Kamudoni

  7. University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK

    Nicola Anderson, Alastair K. Denniston & Xiaoxuan Liu

  8. Birmingham Law School, University of Birmingham, Birmingham, UK

    Rosie Harding

  9. Centre for Ethnic Health Research, National Institute for Health and Care Research Applied Research Collaboration East Midlands, University of Leicester, Leicester, UK

    Kamlesh Khunti

  10. Diabetes Research Centre, University of Leicester, Leicester, UK

    Kamlesh Khunti

  11. Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK

    Dipak Kotecha

  12. West Midlands NHS Secure Data Environment, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK

    Dipak Kotecha

  13. Yale School of Medicine, Yale University, New Haven, CT, USA

    Harlan Krumholz

  14. Health Research Authority, London, UK

    Barbara Molony-Oates

  15. Nature Medicine, New York, NY, USA

    Joao Monteiro

  16. Clinical Practice Research Datalink, Medicines and Healthcare products Regulatory Agency, London, UK

    Puja Myles

  17. Medicines and Healthcare products Regulatory Agency, London, UK

    Khadija Rerhou Rantell

  18. Health Canada, Ottawa, Ontario, Canada

    Katherine Soltys

  19. Cancer Research Advocacy Forum, London, UK

    Roger Wilson

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Contributions

Concept and design, and acquisition, and data analysis: O.L.A., M.J.C., S.C.R. and P.K. O.L.A. and M.J.C. had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. Interpretation of data: all authors. Drafting of the manuscript: O.L.A. and M.J.C. Critical revision of the manuscript for intellectual content: all authors.

Corresponding author

Correspondence to Olalekan Lee Aiyegbusi.

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Competing interests

O.L.A. receives funding from the NIHR Birmingham Biomedical Research Centre (BRC), NIHR Blood and Transplant Research Unit (BTRU) in Precision Transplant and Cellular Therapeutics, NIHR Applied Research Collaboration (ARC) West Midlands, UK Research and Innovation (UKRI), LifeArc, Health Foundation, Merck, Gilead, Anthony Nolan, Sarcoma UK and GSK. O.L.A. declares personal fees from Gilead Sciences, Merck and GSK outside the submitted work. S.C.R. receives funding from UK SPINE and Merck, and declares personal fees from Merck. M.J.C. is director of the Birmingham Health Partners Centre for Regulatory Science and Innovation, director of the Centre for the Centre for Patient Reported Outcomes Research and an NIHR Senior Investigator. M.J.C. receives funding from the NIHR, UKRI, NIHR Birmingham BRC, the NIHR Surgical Reconstruction and Microbiology Research Centre, NIHR ARC West Midlands, LifeArc, UK SPINE, European Regional Development Fund—Demand Hub and Health Data Research UK at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Innovate UK (part of UKRI), Macmillan Cancer Support, UCB Pharma, Janssen, GSK and Gilead. M.C. has received personal fees from Astellas, Aparito, CIS Oncology, Takeda, Merck, Daiichi Sankyo, Glaukos, GSK, Pfizer, the Patient-Centered Outcomes Research Institute and Vertex outside the submitted work. In addition, a family member owns shares in GSK. N.A. is an NIHR Senior Research Leader and receives funding from the NIHR, NIHR ARC West Midlands and NIHR Birmingham BRC. S.E.H. receives funding from the NIHR, NIHR BTRU in Precision Transplant and Cellular Therapeutics, NIHR Birmingham BRC, NIHR (ARC) West Midlands, UKRI and UK SPINE. S.E.H. declares personal fees from Cochlear, Pfizer, Rinri Therapeutics, Astra Zeneca, Aparito and CIS Oncology outside the submitted work. K.K. has acted as a consultant, speaker or received grants for investigator-initiated studies for Astra Zeneca, Bayer, Novo Nordisk, Sanofi-Aventis, Servier, Lilly and Merck Sharp & Dohme, Boehringer Ingelheim, Oramed Pharmaceuticals, Pfizer, Roche, Daiichi Sankyo, Applied Therapeutics, Embecta and Nestle Health Science. K.K. is supported by the NIHR Applied Research Collaboration East Midlands (ARC EM), the NIHR Leicester BRC and the British Heart Foundation (BHF) Centre of Excellence. D.K. reports grants from the NIHR (CDF-2015-08-074 RATE-AF, NIHR130280 DaRe2THINK, NIHR132974 D2T-NeuroVascular, NIHR203326 Biomedical Research Centre), the BHF (PG/17/55/33087, AA/18/2/34218 and FS/CDRF/21/21032), the EU/EFPIA Innovative Medicines Initiative (BigData@Heart 116074), EU Horizon and UKRI (HYPERMARKER 101095480), UK National Health Service—Data for R&D-Subnational Secure Data Environment programme, UK Department for Business, Energy & Industrial Strategy Regulators Pioneer Fund, the Cook & Wolstenholme Charitable Trust and the European Society of Cardiology supported by educational grants from Boehringer Ingelheim/BMS-Pfizer Alliance/Bayer/Daiichi Sankyo/Boston Scientific, the NIHR/University of Oxford Biomedical Research Centre and BHF/University of Birmingham Accelerator Award (STEEER-AF); in addition, D.K. has received research grants and advisory board fees from Bayer, Amomed and Protherics Medicines Development; all are outside the submitted work. C.M. receives funding from NIHR Surgical Reconstruction and Microbiology Research Centre, UKRI, NIHR, NIHR BTRU in Precision Transplant and Cellular Therapeutics and declares personal fees from Aparito outside the submitted work. A.D. is deputy director of the Birmingham Health Partners Centre for Regulatory Science and Innovation and is an NIHR Senior Investigator. A.D. receives funding from the NIHR, UKRI and NIHR Birmingham BRC. J.M. is chief editor at Nature Medicine and has excused himself from the peer review and editorial process of this article. P.M. is director of the Clinical Practice Research Datalink, a UK government real-world data research service that also provides clinical trial recruitment services. R.H. receives funding from the Leverhulme Trust.

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Aiyegbusi, O.L., Cruz Rivera, S., Kamudoni, P. et al. Recommendations to promote equity, diversity and inclusion in decentralized clinical trials. Nat Med 30, 3075–3084 (2024). https://doi.org/10.1038/s41591-024-03323-w

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