Abstract
Five eminent stroke neurologists were asked to share their opinions and perspectives on this important issue. As intended when these experts were asked to share their views, divergent conclusions were generated. Dr. Sandercock supports the use of large trials in acute stroke therapy development to ensure that treatments with potentially modest effects are not abandoned. Dr. Hennerici offers several cogent arguments to support small acute stroke trials, suggesting that well evaluated patients should be studied in focused trials. Dr. Orgogozo suggests that small acute stroke trials can detect substantial as opposed to modest treatment effects and that large trials with agents of uncertain safety might lead to unintended harm. Drs. Gorelick and Davis take the middle ground. They both suggest that the size of an individual trial directly depends upon the type of treatment effect to be assessed and that both mega trials and smaller, more focused trials have their own particular place in the array of drug trial possibilities.
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Sandercock, P., Hennerici, M.G., Orgogozo, JM., Davis, S.M., Gorelick, P.B. (2001). Mega Trials Versus Small Trials in Stroke. In: Fisher, M., Bogousslavsky, J. (eds) Current Review of Cerebrovascular Disease. Current Medicine Group, London. https://doi.org/10.1007/978-1-4684-0001-4_22
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DOI: https://doi.org/10.1007/978-1-4684-0001-4_22
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