Alternative trial design in amyotrophic lateral sclerosis saves time and patients

Amyotroph Lateral Scler. 2007 Oct;8(5):266-9. doi: 10.1080/17482960701419497.

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Amyotrophic Lateral Sclerosis / economics*
  • Amyotrophic Lateral Sclerosis / therapy*
  • Clinical Trials as Topic / economics*
  • Clinical Trials as Topic / methods
  • Confidence Intervals
  • Double-Blind Method
  • Humans
  • Odds Ratio
  • Research Design*
  • Retrospective Studies
  • Sample Size
  • Survival Analysis
  • Time Factors
  • Vitamin E / therapeutic use*

Substances

  • Vitamin E