Selecting informative patients for phase 2 progressive trials in MS: Design considerations for phase 2 clinical trials in progressive MS

Author:

Koch Marcus W1ORCID,Camara-Lemarroy Carlos1,Strijbis Eva2ORCID,Mostert Jop3,Leavitt Victoria M4ORCID,Repovic Pavle5,Bowen James D5ORCID,Comtois Jacynthe6,Uitdehaag Bernard2,Cutter Gary7ORCID

Affiliation:

1. Department of Clinical Neurosciences, University of Calgary, Calgary, AB, Canada

2. Department of Neurology, MS Center Amsterdam, Amsterdam University Medical Center, Amsterdam, The Netherlands

3. Department of Neurology, Rijnstate Hospital, Arnhem, The Netherlands

4. Department of Neurology, Columbia University Irving Medical Center, New York, NY, USA

5. Multiple Sclerosis Center, Swedish Neuroscience Institute, Seattle, WA, USA

6. Department of Medicine, Neurology Service, Hôpital de la Cité-de-la-Santé, Laval, QC, Canada

7. Department of Biostatistics, The University of Alabama at Birmingham, Birmingham, AL, USA

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.

Publisher

SAGE Publications

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