Using Historical Lesion Volume Data in the Design of a New Phase II Clinical Trial in Acute Stroke
Author(s) -
John Whitehead,
Kim Bolland,
Elsa ValdésMárquez,
Anela Lihic,
Myzoon Ali,
Kennedy R. Lees
Publication year - 2009
Publication title -
stroke
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.397
H-Index - 319
eISSN - 1524-4628
pISSN - 0039-2499
DOI - 10.1161/strokeaha.108.531442
Subject(s) - medicine , sample size determination , lesion , placebo , odds ratio , clinical trial , stroke (engine) , magnetic resonance imaging , radiology , nuclear medicine , surgery , pathology , statistics , mechanical engineering , alternative medicine , mathematics , engineering
Clinical research into the treatment of acute stroke is complicated, is costly, and has often been unsuccessful. Developments in imaging technology based on computed tomography and magnetic resonance imaging scans offer opportunities for screening experimental therapies during phase II testing so as to deliver only the most promising interventions to phase III. We discuss the design and the appropriate sample size for phase II studies in stroke based on lesion volume.
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