Improving the efficiency of clinical trials in multiple sclerosis.

ABSTRACT:

Background

Phase 3 clinical trials for disease-modifying therapies in relapsing-remitting multiple sclerosis (RRMS) have utilized a limited number of conventional designs with a high degree of success. However, these designs limit the types of questions that can be addressed, and the time and cost required. Moreover, trials involving people with progressive multiple sclerosis (MS) have been less successful.

Objective

The objective of this paper is to discuss complex innovative trial designs, intermediate and composite outcomes and to improve the efficiency of trial design in MS and broaden questions that can be addressed, particularly as applied to progressive MS.

Methods

We held an international workshop with experts in clinical trial design.

Results

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SUBMITTER: Marrie RA 

PROVIDER: S-EPMC10413792 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature