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Can emergency medicine research benefit from adaptive design clinical trials?
  1. Laura Flight1,
  2. Steven A Julious1,
  3. Steve Goodacre2
  1. 1Medical Statistics Group, School of Health and Related Research, University of Sheffield, Sheffield, UK
  2. 2Health Services Research, School of Health and Related Research, University of Sheffield, Sheffield, UK
  1. Correspondence to Professor Steven A Julious, Medical Statistics Group, School of Health and Related Research, University of Sheffield, Sheffield S14DA, UK; s.a.julious{at}sheffield.ac.uk

Abstract

Background Adaptive design clinical trials use preplanned interim analyses to determine whether studies should be stopped or modified before recruitment is complete. Emergency medicine trials are well suited to these designs as many have a short time to primary outcome relative to the length of recruitment. We hypothesised that the majority of published emergency medicine trials have the potential to use a simple adaptive trial design.

Methods We reviewed clinical trials published in three emergency medicine journals between January 2003 and December 2013. We determined the proportion that used an adaptive design as well as the proportion that could have used a simple adaptive design based on the time to primary outcome and length of recruitment.

Results Only 19 of 188 trials included in the review were considered to have used an adaptive trial design. A total of 154/165 trials that were fixed in design had the potential to use an adaptive design.

Conclusions Currently, there seems to be limited uptake in the use of adaptive trial designs in emergency medicine despite their potential benefits to save time and resources. Failing to take advantage of adaptive designs could be costly to patients and research. It is recommended that where practical and logistical considerations allow, adaptive designs should be used for all emergency medicine clinical trials.

  • statistics
  • efficiency
  • research, methods

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Footnotes

  • Contributors SAJ and SG initiated the research into adaptive designs in emergency medicine. SAJ conceived the idea of the review. LF was responsible for the searching of articles, subsequent data extraction and analysis. This was supervised by SAJ. LF drafted the manuscript and SAJ and SG contributed substantially to its revision. LF takes responsibility for the paper as a whole.

  • Funding LF was funded by a Research Methods Fellowship (RMFI-2013-04-011 Goodacre) supported by the National Institute for Health Research. The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National Institute for Health Research, the Department of Health or the University of Sheffield.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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