Abstract
Background
Whereas anecdotal reports suggest that the use of decentralized clinical trial (DCT) solutions can improve participant diversity in clinical trials there is no quantitative evidence to support such reports.
Methods
Tufts CSDD conducted this initial study based on data collected from prior research and publicly available data drawn from Clinicaltrials.gov to compare and contrast participant diversity in trials which included various DCT solutions – virtual visits or televisits, home visits, devices or wearables, and the use of local labs.
Results
The results of this analysis indicate that the use of local labs is associated with a lower percentage of white participants; the use of virtual visits or televisits is associated with a lower percentage of Black participants; and the use of devices or wearables was not associated with any significant change in participant demographics. The use of home visits could not be tested for significant differences.
Similar content being viewed by others
References
Pfizer. Pfizer conducts first virtual clinical trial allowing patients to participate regardless of geography. June 7, 2011. Available online: https://www.pfizer.com/news/press-release/press-release-detail/pfizer_conducts_first_virtual_clinical_trial_allowing_patients_to_participate_regardless_of_geography. Accessed 6/8/2023.
Oracle. The Accelerated Evolution of Clinical Trials in a Pandemic Environment [report]. 2020. Available from: https://go.oracle.com/researchacceleratedtrials?elqCampaignId=257896. Accessed September 21, 2022.
Price J, Goodson N, Warren EJ, Wicks P, Reites J. Resilient design: decentralized trials recovered faster from the impact of CoViD19 than traditional site-based designs. Expert Rev Med Devices. 2021;18:1–4. https://doi.org/10.1080/17434440.2021.2014818.
The Accelerated Evolution. Of clinical trials in a pandemic environment. Oracle Research Report; November 2020.
Le Breton S, Lamberti MJ, Dion A, Getz K. COVID-19 and its impact on the future of clinical trial execution. Appl Clin Trials. (2020).
Global Trends in. R&D 2023 activity, Productivity, and enablers. IQVIA Institute; 2023.
Getz K. Optimizing the process for adopting DCT solutions. Appl Clin Trials June 2023; 32 (6): https://www.appliedclinicaltrialsonline.com/view/optimizing-the-process-for-adopting-dct-solutions.
Anderson D, Fox J, Elsman N. Digital R&D transforming the future of Clinical Development. Deloitte Insights. 2021; 3–9.
Dorsey ER, Kluger B, Lipset C. The New Normal in clinical trials: decentralized studies. Ann Neurol. 2020;88(5):863–6.
Perry B, Geoghegan C, Lin L et al. Patient preferences for using mobile technologies in clinical trials. (2019) Contemporary Clinical Trials Communications. 15.
DiMasi J, Smith Z, Oakley-Girvan I, et al. Assessing the financial value of decentralized clinical trials. Ther Innov Regul Sci. 2023;57:209-219.
Costello M, Larrabee P. Sites still necessary for decentralized trials. Appl Clin Trials. 2021;30(10).
Khozin S, Coravos A. Decentralized trials in the age of real-world evidence and inclusivity in clinical investigations. Clin Pharmacol Ther. 2019;106:25–7. https://doi.org/10.1002/cpt.1441.
Sommer C, Zuccolin D, Arnera V, Schmitz N, Adolfsson P, Colombo N, et al. Building clinical trials around patients: evaluation and comparison of decentralized and conventional site models in patients with low back pain. Contemp Clin Trials Commun. 2018 Sep;11:120-126. doi: 10.1016/j.conctc.2018.06.008. [Medline: 30094387]
Hirsch I, Martinez J, Dorsey E, Finken G, et al. Incorporating site-less clinical trials into Drug Development: a Framework for Action. Clin Ther. 2017;39(5):1064–76. https://doi.org/10.1016/j.clinthera.2017.03.018.
Site Perspectives on Decentralized Clinical Trials. 2022. SCRS and Medidata white paper.
Gao F, Soloman M, Roy A, Chaplin W. Why decentralize clinical trials are the way of the future. Appl Clin Trials April 5, 2021. https://www.appliedclinicaltrialsonline.com/view/why-decentralized-clinical-trials-are-the-way-of-the-future.
Getz K, Smith Z, Botto E et al. New benchmarks on Protocol Amendment practices, trends and their impact on clinical trial performance. 2023. Epub ahead of print 14 July 2023. https://doi.org/10.21203/rs.3.rs-3168679/v1.
Anderson A, Borfitz D, Getz K. Global Public Attitudes about Clinical Research and patient experiences with clinical trials. JAMA Netw Open. 2018;1(6):e182969. https://doi.org/10.1001/jamanetworkopen.2018.2969.
Impact Assessment of Decentralized Clinical Trials (DCT). Awareness in the Clinical Research Industry. SCRS white paper; 2020.
Author information
Authors and Affiliations
Corresponding author
Additional information
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Rights and permissions
Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.
About this article
Cite this article
Smith, Z., Getz, K. Examining the Association Between DCT Solutions Use and Participant Diversity in Clinical Trials. Ther Innov Regul Sci (2024). https://doi.org/10.1007/s43441-024-00659-w
Received:
Accepted:
Published:
DOI: https://doi.org/10.1007/s43441-024-00659-w