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Clinical Trial

Alternative trial design in amyotrophic lateral sclerosis saves time and patients

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Pages 266-269 | Received 26 Sep 2006, Accepted 25 Apr 2007, Published online: 10 Jul 2009
 

Abstract

A sequential trial design is an alternative for the classical trial design with a fixed sample size, that permits stopping a trial as soon as enough evidence for a treatment effect, or a lack thereof, is obtained. This study aimed to determine the difference in efficiency of time and patient number between a classical trial design and a sequential trial design. In this study we re‐analysed a previously published classically designed clinical trial according to a sequential trial design. We subsequently determined the difference in total running time and patient number. We found that the sequential analysis offered a gain in time of 38%. We conclude that the sequential trial design may in certain situations be superior to the classical design.

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