Clinical trial design for progressive MS trials. (October 2017)

• Record Type: Journal Article
• Authors: Pardini, Matteo; Cutter, Gary; Sormani, Maria Pia
• Other Names: Chataway Jeremy guest-editor.; Fox Robert guest-editor.
• Is Part Of: Multiple sclerosis. Volume 23:Number 12(2017)
• Page Start: 1642
• Page End: 1648
• Publication Date: 2017-10
• Subjects: Progressive multiple sclerosis -- clinical trial design; Central nervous system -- Diseases -- Periodicals; Myelin sheath -- Diseases -- Periodicals; Inflammation -- Periodicals; Multiple sclerosis -- Periodicals; Central Nervous System Diseases -- Periodicals; Demyelinating Diseases -- Periodicals; Inflammation -- Periodicals; Multiple Sclerosis -- Periodicals; Système nerveux central -- Maladies -- Périodiques; Gaine de myéline -- Maladies -- Périodiques; Inflammation (Pathologie) -- Périodiques; Sclérose en plaques -- Périodiques; Electronic journals; 616.834005
• DOI: 10.1177/1352458517729461
• Languages: English
• ISSNs: 1352-4585

Abstract

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.