Assessing the Current and Potential Use of Adaptive Study Designs in Emergency Medicine Clinical Trials

• Activity Number: 259
• Type: Contributed
• Date/Time: Monday, August 10, 2015 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Laura Flight* and Steven A. Julious and Steve Goodacre
• Companies: University of Sheffield and University of Sheffield and University of Sheffield
• Keywords: Emergency Medicine ; Clinical Trials ; Adaptive Designs

Abstract

In a traditional clinical study no ongoing changes are made to the design or analysis as the trial progresses - a fixed design. An alternative is to use interim assessments of the accumulating data to inform changes to the trial - an adaptive design. We hypothesised that the majority of trials in an emergency medicine setting could potentially be adaptive. This is because the time for patients to reach the primary outcome is short compared to the length of recruitment. This allows time to implement trial adaptations before recruitment ends. A review of emergency medicine trials published in three journals was conducted to determine how adaptive trial designs are currently used in this setting. Of the 188 trials included in the review the median time from recruitment to the primary outcome was one day and trials recruited over a median of 474 days. Only 19/188 used pre-planned adaptive methods and 4/188 used unplanned interims. 154/165 fixed design trials could potentially have been adaptive. The fact that emergency medicine clinical trials are well suited to adaptive designs is not being utilised. We recommend where practical emergency medicine trials should use adaptive designs.