Decentralised clinical trials in multiple sclerosis research

Garjani, Afagh; Liu, Brandon Jun-Yu; Allen, Christopher Martin; Gunzler, Douglas David; Gerry, Stephen William; Planchon, Sarah Marie; das Nair, Roshan; Chataway, Jeremy; Tallantyre, Emma C; Ontaneda, Daniel; Evangelou, Nikos

Abstract

Randomised controlled trials (RCTs) play an important role in multiple sclerosis (MS) research, ensuring that new interventions are safe and efficacious before their introduction into clinical practice. Trials have been evolving to improve the robustness of their designs and the efficiency of their conduct. Advances in digital and mobile technologies in recent years have facilitated this process and the first RCTs with decentralised elements became possible. Decentralised clinical trials (DCTs) are conducted remotely, enabling participation of a more heterogeneous population who can participate in research activities from different locations and at their convenience. DCTs also rely on digital and mobile technologies which allows for more flexible and frequent assessments. While hospitals quickly adapted to e-health and telehealth assessments during the COVID-19 pandemic, the conduct of conventional RCTs was profoundly disrupted. In this paper, we review the existing evidence and gaps in knowledge in the design and conduct of DCTs in MS.

Citation

Garjani, A., Liu, B. J., Allen, C. M., Gunzler, D. D., Gerry, S. W., Planchon, S. M., …Evangelou, N. (2023). Decentralised clinical trials in multiple sclerosis research. Multiple Sclerosis Journal, 29(3), 317-325. https://doi.org/10.1177/13524585221100401

• Journal Article Type: Article
• Acceptance Date: Apr 19, 2022
• Online Publication Date: Jun 23, 2022
• Publication Date: 2023-03
• Deposit Date: Apr 21, 2022
• Publicly Available Date: Apr 21, 2022
• Journal: Multiple Sclerosis Journal
• Print ISSN: 1352-4585
• Electronic ISSN: 1477-0970
• Publisher: SAGE Publications
• Peer Reviewed: Peer Reviewed
• Volume: 29
• Issue: 3
• Pages: 317-325
• DOI: https://doi.org/10.1177/13524585221100401
• Keywords: Neurology (clinical); Neurology
• Public URL: https://nottingham-repository.worktribe.com/output/7784392
• Publisher URL: https://journals.sagepub.com/doi/full/10.1177/13524585221100401