Flight Laura, Julious Steven A, Goodacre Steve
Medical Statistics Group, School of Health and Related Research, University of Sheffield, Sheffield, UK.
Health Services Research, School of Health and Related Research, University of Sheffield, Sheffield, UK.
Emerg Med J. 2017 Apr;34(4):243-248. doi: 10.1136/emermed-2016-206046. Epub 2016 Oct 28.
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.
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.
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.
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.
适应性设计临床试验采用预先计划的中期分析,以确定在招募完成前研究是否应停止或修改。急诊医学试验非常适合这些设计,因为相对于招募时间,许多试验至主要结局的时间较短。我们假设,大多数已发表的急诊医学试验有使用简单适应性试验设计的潜力。
我们回顾了2003年1月至2013年12月间在三种急诊医学期刊上发表的临床试验。我们根据至主要结局的时间和招募时间,确定了使用适应性设计的试验比例以及本可使用简单适应性设计的试验比例。
纳入综述的188项试验中,仅有19项被认为采用了适应性试验设计。在设计上为固定设计的165项试验中,共有154项有使用适应性设计的潜力。
目前,尽管适应性试验设计在节省时间和资源方面有潜在益处,但在急诊医学中的应用似乎有限。不利用适应性设计可能对患者和研究造成高昂代价。建议在实际和后勤考虑允许的情况下,所有急诊医学临床试验均应采用适应性设计。