Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2024 Nov;30(11):3075-3084.
doi: 10.1038/s41591-024-03323-w. Epub 2024 Oct 29.

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

Olalekan Lee Aiyegbusi  1   2   3   4   5 , Samantha Cruz Rivera  6   7 , Paul Kamudoni  8 , Nicola Anderson  6   9   10   11 , Philip Collis  6 , Alastair K Denniston  9   7   11 , Rosie Harding  12 , Sarah E Hughes  6   9   10   13 , Kamlesh Khunti  14   15 , Dipak Kotecha  9   16   17 , Harlan Krumholz  18 , Xiaoxuan Liu  9   7   11 , Christel McMullan  6   13 , Barbara Molony-Oates  19 , Joao Monteiro  20 , Puja Myles  21 , Khadija Rerhou Rantell  22 , Katherine Soltys  23 , Ravinder Verdi  6 , Roger Wilson  6   24 , Melanie J Calvert  6   9   10   13   7
Affiliations
Review

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

Olalekan Lee Aiyegbusi et al. Nat Med. 2024 Nov.

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.

PubMed Disclaimer

Conflict of interest statement

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.

References

    1. US Food and Drug Administration. The evolving role of decentralized clinical trials and digital health technologies. FDA https://www.fda.gov/drugs/news-events-human-drugs/evolving-role-decentra... (accessed 25 September 2024).
    1. Shen, R. et al. iinternet versus noninternet participation in a decentralized clinical trial: lessons from the ADAPTABLE study. J. Am. Heart Assoc. 12, e027899 (2023). - PubMed - PMC
    1. Retzer, A. et al. A toolkit for capturing a representative and equitable sample in health research. Nat. Med. 29, 3259–3267 (2023). - PubMed - PMC
    1. Adesoye, T., Katz, M. H. G. & Offodile, A. C. 2nd Meeting trial participants where they are: decentralized clinical trials as a patient-centered paradigm for enhancing accrual and diversity in surgical and multidisciplinary trials in oncology. JCO Oncol. Pract. 19, 317–321 (2023). - PubMed
    1. Nassif, M. et al. Recruitment strategies of a decentralized randomized placebo controlled clinical trial: the canagliflozin impact on health status, quality of life and functional status in heart failure (CHIEF-HF) trial. J. Card. Fail. 29, 863–869 (2023). - PubMed

LinkOut - more resources