Why the study?
Previous phase III MS trial designs have limitations, endpoints that are only partially patient-relevant, and lack long-term efficacy and safety data beyond pivotal trial time frames.
Population
Published phase III pivotal trials of immunomodulatory drugs in multiple sclerosis
Design
Systematic overview
Authors
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MS trial endpoints may inadequately reflect patient priorities; challenges current designs and supports PRO-inclusive long-term trials with surrogates.
Future clinical trials in multiple sclerosis must prioritize patient-reported outcomes and surrogate predictive markers to improve personalized care and long-term safety assessments.
Gehr et al. (2019) studied this question.
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