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A Protocol for the Use of Remotely-Supervised Transcranial Direct Current Stimulation tDCS in Multiple Sclerosis MS
Published on: December 26, 2015
Decentralised clinical trials in multiple sclerosis research
Afagh Garjani1, Brandon Jun-Yu Liu2, Christopher Martin Allen1
1Mental Health and Clinical Neurosciences Academic Unit, School of Medicine, University of Nottingham, Nottingham, UK/Academic Neurology, Nottingham University Hospitals NHS Trust, Nottingham, 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.
Insights
Decentralised clinical trials (DCTs) leverage digital technology for remote multiple sclerosis (MS) research, enhancing participant diversity and data collection flexibility. This review examines DCT evidence and knowledge gaps in MS research.
Area of Science:
- Neurology
- Clinical Research Methodology
Background:
- Randomised controlled trials (RCTs) are crucial for evaluating multiple sclerosis (MS) interventions.
- Traditional RCTs faced disruptions, particularly during the COVID-19 pandemic.
- Digital and mobile technologies have enabled the development of decentralised clinical trials (DCTs).
Purpose of the Study:
- To review the current evidence on the design and conduct of DCTs in MS research.
- To identify existing knowledge gaps in the implementation of DCTs for MS.
Main Methods:
- Review of existing literature and evidence on decentralised clinical trials in multiple sclerosis.
- Analysis of the role of digital and mobile technologies in remote trial conduct.
- Examination of challenges and benefits associated with DCTs in MS.
Main Results:
- DCTs offer remote participation, increasing population heterogeneity and convenience.
- Digital tools facilitate flexible and frequent assessments in decentralised settings.
- The COVID-19 pandemic highlighted the need for adaptable trial methodologies like DCTs.
Conclusions:
- DCTs represent a significant evolution in clinical trial methodology for multiple sclerosis.
- Further research is needed to address knowledge gaps in designing and conducting MS DCTs.
- DCTs have the potential to improve the efficiency and accessibility of MS research.
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