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Review
. 2023 Mar;29(3):317-325.
doi: 10.1177/13524585221100401. Epub 2022 Jun 23.

Decentralised clinical trials in multiple sclerosis research

Afagh Garjani  1 , Brandon Jun-Yu Liu  2 , Christopher Martin Allen  1 , Douglas David Gunzler  3 , Stephen William Gerry  4 , Sarah Marie Planchon  5 , Roshan das Nair  6 , Jeremy Chataway  7 , Emma C Tallantyre  8 , Daniel Ontaneda  5 , Nikos Evangelou  1
Affiliations
Review

Decentralised clinical trials in multiple sclerosis research

Afagh Garjani et al. Mult Scler. 2023 Mar.

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.

Keywords: Decentralised; clinical trial; digital; multiple sclerosis; randomised controlled trial; remote.

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Conflict of interest statement

The author(s) declared the following potential conflicts of interest with respect to the research, authorship and/or publication of this article: A.G. has received research support from the UK MS Society, speaker honorarium and travel support to attend an educational meeting from the MS Academy, speaker honorarium from Biogen and travel support to attend educational meetings from Novartis and Merck. B.J.L. declares no conflicts of interest. C.M.A. has received speaker honorarium from the MS Academy. DDG has book royalty agreement with Taylor & Francis Publishing. S.W.G. declares no conflicts of interest. S.M.P. has received research funding from Guthy Jackson Charitable Foundation. R.d.N. is the Chair of the National Institute for Health Research (NIHR) for Patient Benefit East Midlands Research Advisory Committee and has received funding for trials from the NIHR. He has received funding to prepare and deliver lectures (speakers’ bureau) on cognitive rehabilitation in MS from Novartis, Merck and Biogen. In the last 3 years, JC has received support from the Efficacy and Evaluation (EME) Programme, a Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership and the Health Technology Assessment (HTA) Programme (NIHR), the UK MS Society, the US National MS Society and the Rosetrees Trust. He is supported, in part, by the NIHR University College London Hospitals (UCLH) Biomedical Research Centre, London, UK. He has been a local principal investigator for a trial in MS funded by the Canadian MS society. A local principal investigator for commercial trials funded by Actelion, Novartis and Roche; and has taken part in advisory boards/consultancy for Azadyne, Janssen, Merck, NervGen, Novartis and Roche. ECT has received honoraria/speaker fees/travel expenses to attend educational meetings from Biogen, Janssen, Merck, Novartis, Roche and Takeda. DO has received research support from the National Institutes of Health, National MS Society, Patient-Centered Outcomes Research Institute (PCORI), Race to Erase MS Foundation, Genentech, Genzyme and Novartis. Consulting fees obtained from Biogen Idec, Genentech/Roche, Genzyme, Janssen, Novartis and Merck. N.E. has served as a member of advisory boards for Biogen, Merck, Novartis and Roche, received grant income from the UK MS Society, MRC, PCORI and NIHR.

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