Selecting informative patients for phase 2 progressive trials in MS: Design considerations for phase 2 clinical trials in progressive MS.
Publication Title
Multiple sclerosis (Houndmills, Basingstoke, England)
Document Type
Article
Publication Date
9-8-2024
Keywords
washington; swedish; swedish neurosci
Abstract
While relapsing-remitting multiple sclerosis (MS) has many therapeutic options, progressive forms of MS remain largely untreatable. Phase 2 clinical trials are our main tool to advance new treatments for progressive MS. Given the complexities of progressive MS, it will likely require many phase 2 trials to improve its treatment. To conduct informative and efficient phase 2 trials, it is important that such trials are designed in a way that they can identify a successful treatment as quickly and with as few participants as possible. In this topical review, we discuss cohort selection, outcome selection, cohort enrichment, and dosing selection as strategies to optimize the efficiency of phase 2 clinical trials in progressive MS.
Area of Special Interest
Neurosciences (Brain & Spine)
Specialty/Research Institute
Neurosciences
DOI
10.1177/13524585241274620
