This review discusses the challenges in designing clinical trials for progressive multiple sclerosis, including patient selection and outcome measures.
Persistent trial design barriers in progressive MS warrant cautious evidence use; leaves open refined selection criteria and endpoints.
The design of clinical trials is a key aspect to maximizing the possibility to detect a treatment effect. This fact is particularly challenging in progressive multiple sclerosis (PMS) studies due to the uncertainty about the right target and/or outcome in phase-2 studies. The aim of this review is to evaluate the current challenges facing the design of clinical trials for PMS. The selection of patients, the instrumental and clinical outcomes that can be used in PMS trials, and issues in their design will be covered in this report.
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Pardini et al. (2017) studied this question.
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