Can placebo-controlled phase 2 disease-modifying therapy trials in MS still be justified?

Gavin Giovannoni¹, Christopher H Hawkes², Jeannette Lechner-Scott³, Michael Levy⁴, E Ann Yeh⁵, George Pepper⁶, Klaus Schmierer⁷

Affiliations

¹ The Blizard Institute, Centre for Neuroscience, Surgery & Trauma, Faculty of Medicine and Dentistry, Queen Mary University of London, London, UK; Clinical Board Medicine (Neuroscience), The Royal London Hospital, Barts Health NHS Trust, London, UK. Electronic address: g.giovannoni@qmul.ac.uk.
² The Blizard Institute, Centre for Neuroscience, Surgery & Trauma, Faculty of Medicine and Dentistry, Queen Mary University of London, London, UK.
³ The University of Newcastle, Australia.
⁴ Massachusetts General Hospital and Harvard Medical School, Massachusetts, USA.
⁵ Department of Paediatrics, Dalla Lana School of Public Health, University of Toronto.
⁶ Shift.ms, Platform, New Station Street, LS1 4JB, United Kingdom.
⁷ The Blizard Institute, Centre for Neuroscience, Surgery & Trauma, Faculty of Medicine and Dentistry, Queen Mary University of London, London, UK; Clinical Board Medicine (Neuroscience), The Royal London Hospital, Barts Health NHS Trust, London, UK.

PMID: 38850685
DOI: 10.1016/j.msard.2024.105698

Editorial

Can placebo-controlled phase 2 disease-modifying therapy trials in MS still be justified?

Gavin Giovannoni et al. Mult Scler Relat Disord. 2024 Jul.

. 2024 Jul:87:105698.

doi: 10.1016/j.msard.2024.105698. Epub 2024 May 31.

Authors

Gavin Giovannoni¹, Christopher H Hawkes², Jeannette Lechner-Scott³, Michael Levy⁴, E Ann Yeh⁵, George Pepper⁶, Klaus Schmierer⁷

Affiliations

¹ The Blizard Institute, Centre for Neuroscience, Surgery & Trauma, Faculty of Medicine and Dentistry, Queen Mary University of London, London, UK; Clinical Board Medicine (Neuroscience), The Royal London Hospital, Barts Health NHS Trust, London, UK. Electronic address: g.giovannoni@qmul.ac.uk.
² The Blizard Institute, Centre for Neuroscience, Surgery & Trauma, Faculty of Medicine and Dentistry, Queen Mary University of London, London, UK.
³ The University of Newcastle, Australia.
⁴ Massachusetts General Hospital and Harvard Medical School, Massachusetts, USA.
⁵ Department of Paediatrics, Dalla Lana School of Public Health, University of Toronto.
⁶ Shift.ms, Platform, New Station Street, LS1 4JB, United Kingdom.
⁷ The Blizard Institute, Centre for Neuroscience, Surgery & Trauma, Faculty of Medicine and Dentistry, Queen Mary University of London, London, UK; Clinical Board Medicine (Neuroscience), The Royal London Hospital, Barts Health NHS Trust, London, UK.

PMID: 38850685
DOI: 10.1016/j.msard.2024.105698

No abstract available

Keywords: Ethics; Phase 2 clinical trials; Placebo-controlled.

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Conflict of interest statement

Declaration of competing interest In the last two years, Gavin Giovannoni has received compensation for serving as a consultant or speaker for or has received research support from AbbVie, Aslan, Atara Bio, Biogen, BMS-Celgene, GlaxoSmithKline, Janssens/J&J, Japanese Tobacco, Jazz Pharmaceuticals, LifNano, Merck & Co, Merck KGaA/EMD, Moderna, Serono, Moderna, Novartis, Sandoz, Sanofi and Roche/Genentech.

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Can placebo-controlled phase 2 disease-modifying therapy trials in MS still be justified?

Affiliations

Can placebo-controlled phase 2 disease-modifying therapy trials in MS still be justified?

Authors

Affiliations

Conflict of interest statement

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Medical