M. P. Sormani, PhD, M. Rovaris, MD, F. Bagnato, MD, P. Molyneux, MD, P. Bruzzi, MD, C. Pozzilli, MD, D. H. Miller, MD, G. Comi, MD and M. Filippi, MD
From the Neuroimaging Research Unit (Drs. Sormani, Rovaris, Comi, and Filippi), Department of Neuroscience, Scientific Institute and University Ospedale San Raffaele, Milan; Unit of Clinical Epidemiology and Trials (Drs. Sormani and Bruzzi), National Institute for Cancer Research, Genoa; Department of Neuroscience (Drs. Bagnato and Pozzilli), University "La Sapienza," Rome; Italy; and NMR Research Unit (Dr. Molyneux), Institute of Neurology, London, United Kingdom.
The authors estimated the sample sizes needed for exploratory trials of MS assessing the efficacy of new treatments in reducing the number of new enhancing lesions vs those of interferon-ß or glatiramer acetate.
The sample sizes per arm ranged from 868 (effect: 20%) to 94 (effect: 50%) for patients with relapsing–remitting MS and from 2,484 (effect: 20%) to 361 (effect: 50%) for patients with secondary progressive MS.
In MS, exploratory trials of new
vs available therapies require large numbers of patients, even when MR
end-points are used.
© 2001 American Academy of Neurology