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Adaptive Platform Trials to Transform Amyotrophic Lateral Sclerosis Therapy Development
Journal article   Open access   Peer reviewed

Adaptive Platform Trials to Transform Amyotrophic Lateral Sclerosis Therapy Development

Sabrina Paganoni, James D Berry, Melanie Quintana, Eric Macklin, Benjamin R Saville, Michelle A Detry, Marianne Chase, Alexander V Sherman, Hong Yu, Kristin Drake, …
Annals of neurology, Vol.91(2), pp.165-175
02/2022
DOI: 10.1002/ana.26285
PMID: 34935174
url
https://doi.org/10.1002/ana.26285View
Published (Version of record) Open Access

Abstract

Current therapeutic development in amyotrophic lateral sclerosis (ALS) relies on individual randomized clinical trials to test a specific investigational product in a single patient population. This approach has intrinsic limitations, including cost, time, and lack of flexibility. Adaptive platform trials represent a novel approach to investigate several interventions for a single disease in a continuous manner. Already in use in oncology, this approach is now being employed more often in neurology. Here, we describe a newly launched platform trial for ALS. The Healey ALS Platform Trial is testing multiple investigational products concurrently in people with ALS, with the goal of rapidly identifying novel treatments, biomarkers, and trial endpoints. ANN NEUROL 2022;91:165-175.
Biomarkers Amyotrophic Lateral Sclerosis - therapy Animals Clinical Trials as Topic - legislation & jurisprudence Endpoint Determination Humans Research Design

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