Decentralised clinical trials in multiple sclerosis research

Author:

Garjani Afagh1ORCID,Liu Brandon Jun-Yu2,Allen Christopher Martin1ORCID,Gunzler Douglas David3,Gerry Stephen William4,Planchon Sarah Marie5ORCID,das Nair Roshan6ORCID,Chataway Jeremy7,Tallantyre Emma C8ORCID,Ontaneda Daniel5ORCID,Evangelou Nikos1ORCID

Affiliation:

1. Mental Health and Clinical Neurosciences Academic Unit, School of Medicine, University of Nottingham, Nottingham, UK/Academic Neurology, Nottingham University Hospitals NHS Trust, Nottingham, UK

2. School of Psychology, University of Nottingham, Nottingham, UK

3. The MetroHealth System and Case Western Reserve University, Cleveland, OH, USA

4. Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK

5. Mellen Center for Multiple Sclerosis, Cleveland Clinic, Cleveland, OH, USA

6. Mental Health and Clinical Neurosciences Academic Unit, School of Medicine, University of Nottingham, Nottingham, UK/Institute of Mental Health, Nottinghamshire Healthcare NHS Foundation Trust, Nottingham, UK

7. Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, UCL Queen Square Institute of Neurology, Faculty of Brain Sciences, University College London, London, UK/National Institute for Health Research, University College London Hospitals Biomedical Research Centre, London, UK/MRC CTU at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK

8. Helen Durham Neuro-Inflammatory Unit, University Hospital of Wales, Cardiff, UK/Division of Psychological Medicine and Clinical Neurosciences, Cardiff University, Cardiff, UK

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.

Publisher

SAGE Publications

Subject

Neurology (clinical),Neurology

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