Decentralized clinical trials-balancing promise and pitfalls in modern research: a systematic review
DOI:
https://doi.org/10.18203/2349-3259.ijct20252201Keywords:
Decentralized clinical trials, Digital health technology, Patient-centric trials, Regulatory challenges, Trial accessibilityAbstract
Background: Traditional clinical trials often face limitations in participant diversity and accessibility due to geographic and logistical constraints. Decentralized clinical trials (DCTs) have emerged as a potential solution to address these challenges by leveraging digital and remote technologies. Despite their advantages, there remains a lack of comprehensive understanding regarding the opportunities and challenges associated with DCTs. This systematic review explores the opportunities and challenges of DCTs, providing insights into their implementation and impact on clinical research. The review analyses DCTs' effects on trial conduct and outcomes, offering recommendations for future design and execution.
Methods: A systematic literature review was conducted following PRISMA guidelines, searching major databases for studies published between 2018 and March 2024. The review analyzed 18 peer-reviewed articles, assessing risk of bias using an adapted Cochrane tool.
Results: The results highlighted that DCTs enhance participant engagement, improve accessibility and increase participant diversity, offering potential cost savings and improved trial efficiency. However, challenges such as ensuring data integrity, overcoming technological barriers and addressing regulatory compliance were also noted. The majority of the included studies demonstrated a low risk of bias across all domains, enhancing the reliability of these findings.
Conclusions: This review underscores DCTs' potential to transform clinical research by improving efficiency, accessibility and participant diversity. Successful implementation requires addressing technological, ethical and regulatory challenges. Future research should focus on standardized best practices, equity issues and comparative studies with traditional trials. These findings have significant implications for shaping future clinical trials.
Metrics
References
Fogel DB. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: a review. Contemp Clin Tri Commun. 2018;11:156-64. DOI: https://doi.org/10.1016/j.conctc.2018.08.001
Shea L, Pesa J, Geonnotti. Improving diversity in study participation: Patient perspectives on barriers, racial differences and the role of communities. Health Expect. 2022;25(4):1979-87. DOI: https://doi.org/10.1111/hex.13554
Nwolise C, Corrie P, Fitzpatrick R. Burden of cancer trial participation: A qualitative sub-study of the INTERIM feasibility RCT. Chronic Illness. 2023;19(1);81-94. DOI: https://doi.org/10.1177/17423953211060253
Cameron D, Willoughby C, Messer D. Assessing participation burden in clinical trials: introducing the patient friction coefficient. Clinical Therap. 2020;42(8):150-9. DOI: https://doi.org/10.1016/j.clinthera.2020.06.015
Chaudhari N, Ravi R, Gogtay NJ. Recruitment and retention of the participants in clinical trials: challenges and solutions. Persp Clin Res 2020;11(2); 64. DOI: https://doi.org/10.4103/picr.PICR_206_19
Tew M, Catchpool M, Furler J. Site-specific factors associated with clinical trial recruitment efficiency in general practice settings: a comparative descriptive analysis. Trials. 2023;24(1):1-8. DOI: https://doi.org/10.1186/s13063-023-07177-4
Petrini C, Mannelli C, Riva L. Decentralized clinical trials (DCTs): A few ethical considerations. Front Publ Health. 2022;10:1081150. DOI: https://doi.org/10.3389/fpubh.2022.1081150
Betcheva, L., Kim, J. Y., Erhun, F., et al. Applying Systems Thinking to Inform Decentralized Clinical Trial Planning and Deployment. Therap Innova Regul Sci. 2023;57(5):1081-98. DOI: https://doi.org/10.1007/s43441-023-00540-2
Ghadessi M, Di J, Wang C, Toyoizumi K, Shao N, Mei C, et al. Decentralized clinical trials and rare diseases: a drug information association innovative design scientific working group (DIA-IDSWG) perspective. Orphanet J Rare Dis. 2023;18(1):79. DOI: https://doi.org/10.1186/s13023-023-02693-7
Bauer R, Brun S, Owens T, Shortino V. Navigating the challenges of central nervous system disease research. Planning for success in CNS clinical development. 2023.
de Jong AJ, Rijssel TI, Zuidgeest MG. Opportunities and challenges for decentralized clinical trials: European regulators’ perspective. Clin Pharmacol Therap. 2022;112(2):344-52. DOI: https://doi.org/10.1002/cpt.2628
Nebie EI, Sawadogo HN, Eeuwijk P. Opportunities and challenges for decentralized clinical trials in sub-Saharan Africa: a qualitative study. BMJ Open. 2023;13(9):75903. DOI: https://doi.org/10.1136/bmjopen-2023-075903
Boxall C, Renz S, Eminton Z. Factors that influence women’s enrolment and ongoing participation in a partially decentralised randomised controlled dermatology trial: a qualitative interview study with participants in the SAFA (Spironolactone for Adult Female Acne) trial. Trials. 2023;24:661. DOI: https://doi.org/10.1186/s13063-023-07630-4
Goodson N, Wicks P, Morgan J. Opportunities and counterintuitive challenges for decentralized clinical trials to broaden participant inclusion. NPJ Digital Med. 2022; 5(1); 58. DOI: https://doi.org/10.1038/s41746-022-00603-y
Singh P, Burden AM, Natanegara F. Design and execution of sustainable decentralized clinical trials. Clin Pharmacol Therap. 2023. DOI: https://doi.org/10.1002/cpt.3009
Cafaro T, LaRiccia PJ, Bandomer B. Remote and semi-automated methods to conduct a decentralized randomized clinical trial. J Clin Translational Sci. 2023;7(1);153. DOI: https://doi.org/10.1017/cts.2023.574
Harmon DM, Noseworthy PA, Yao X. The digitization and decentralization of clinical trials. InMayo Clin Proceed. 2023;98(10):1568-78. DOI: https://doi.org/10.1016/j.mayocp.2022.10.001
Coyle J, Rogers A, Copland R. A secondary qualitative analysis of stakeholder views about participant recruitment, retention and adherence in decentralized clinical trials (DCTs). Trials. 2022;23(1):614. DOI: https://doi.org/10.1186/s13063-022-06521-4
Huh KY, Chung WK, Park J, et al. Feasibility study for a fully decentralized clinical trial in participants with functional constipation symptoms. Clin Transl Sci. 2023;16(11):2177-88. DOI: https://doi.org/10.1111/cts.13617
Hoban HG, Yip TA, Chau JC. The motivation and process for developing a consortium‐wide time and motion study to estimate resource implications of innovations in the use of genome sequencing to inform patient care. Clin Transl Sci. 2024;17(1):13635. DOI: https://doi.org/10.1111/cts.13635
DiMasi JA, Smith Z, Oakley-Girvan I. Assessing the financial value of decentralized clinical trials. Therap Innov Regul Sci. 2023;57(2):209–19. DOI: https://doi.org/10.1007/s43441-022-00454-5
Cummins MR, Burr J, Young L. Decentralized research technology use in multicenter clinical research studies based at US academic research centers. J Clin Transl Sci. 2023;7(1):250. DOI: https://doi.org/10.1017/cts.2023.678
Lau K, Greenwood L, Proctor V. Remote assessments for bone conduction hearing devices during the COVID-19 pandemic. European Arch Oto-Rhino-Laryngol. 2022;279(7):3297-300. DOI: https://doi.org/10.1007/s00405-021-07025-8
Pascalev A. Ethical considerations of decentralized clinical trials. J Clin Transl Sci. 2002;6(1):26–7. DOI: https://doi.org/10.1017/cts.2022.95
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 Trial Commun. 2018;11:120-6. DOI: https://doi.org/10.1016/j.conctc.2018.06.008
Apostolaros M, Babaian D, Corneli A. Legal, regulatory and practical issues to consider when adopting decentralized clinical trials: recommendations from the clinical trials transformation initiative. Ther Innov Regul Sci. 2020;54:779–87. DOI: https://doi.org/10.1007/s43441-019-00006-4
Sehrawat O, Noseworthy PA, Siontis KC, Haddad TC, Halamka JD, Liu H. Data-driven and technology-enabled trial innovations toward decentralization of clinical trials: opportunities and considerations. InMayo Clin Proceed. 2023;98(9):1404-21. DOI: https://doi.org/10.1016/j.mayocp.2023.02.003
Downloads
Published
How to Cite
Issue
Section
