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Clinical trials in amyotrophic lateral sclerosis : a systematic review and perspective

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Wong, Charis, Stavrou, Maria, Elliott, Elizabeth, Gregory, Jenna M., Leigh, Nigel, Pinto, Ashwin A., Williams, Timothy L., Chataway, Jeremy, Swingler, Robert, Parmar, Mahesh K. B. et al.
(2021) Clinical trials in amyotrophic lateral sclerosis : a systematic review and perspective. Brain Communications, 3 (4). fcab242. doi:10.1093/braincomms/fcab242

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Official URL: http://dx.doi.org/10.1093/braincomms/fcab242

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Abstract

Amyotrophic lateral sclerosis is a progressive and devastating neurodegenerative disease. Despite decades of clinical trials, effective disease modifying drugs remain scarce. To understand the challenges of trial design and delivery, we performed a systematic review of phase II, phase II/III and phase III amyotrophic lateral sclerosis clinical drug trials on trial registries and PubMed between 2008 and 2019. We identified 125 trials, investigating 76 drugs and recruiting more than 15000 people with amyotrophic lateral sclerosis. 90% of trials used traditional fixed designs. The limitations in understanding of disease biology, outcome measures, resources and barriers to trial participation in a rapidly progressive, disabling and heterogenous disease hindered timely and definitive evaluation of drugs in two-arm trials. Innovative trial designs, especially adaptive platform trials may offer significant efficiency gains to this end. We propose a flexible and scalable multi-arm, multi-stage trial platform where opportunities to participate in a clinical trial can become the default for people with amyotrophic lateral sclerosis.

Item Type: Journal Article
Subjects: R Medicine > RC Internal medicine
Divisions: Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Statistics and Epidemiology
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Amyotrophic lateral sclerosis, Amyotrphic lateral sclerosis -- Research, Clinical trials
Journal or Publication Title: Brain Communications
Publisher: Oxford University Press
ISSN: 2632-1297
Official Date: 23 October 2021
Dates:
DateEvent
23 October 2021Published
23 October 2021Available
13 September 2021Accepted
Volume: 3
Number: 4
Article Number: fcab242
DOI: 10.1093/braincomms/fcab242
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
MR/R001162/1[MRC] Medical Research Councilhttp://dx.doi.org/10.13039/501100000265
MR/R001162/1Motor Neurone Disease Associationhttp://dx.doi.org/10.13039/501100000406
UNSPECIFIEDAlzheimer's Societyhttp://dx.doi.org/10.13039/501100000320
UNSPECIFIEDAlzheimer's Research UKhttp://viaf.org/viaf/7234152331614803260001

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