平台临床试验的效率：对未来的展望。
Efficiencies of platform clinical trials: A vision of the future.
作者信息
Saville Benjamin R, Berry Scott M
机构信息
Berry Consultants, Austin, TX, USA Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA
Berry Consultants, Austin, TX, USA Adjunct faculty, University of Kansas Medical Center, Department of Biostatistics, KS, USA.
出版信息
Clin Trials. 2016 Jun;13(3):358-66. doi: 10.1177/1740774515626362. Epub 2016 Feb 17.
BACKGROUND
A "platform trial" is a clinical trial with a single master protocol in which multiple treatments are evaluated simultaneously. Adaptive platform designs offer flexible features such as dropping treatments for futility, declaring one or more treatments superior, or adding new treatments to be tested during the course of a trial.
METHODS
A simulation study explores the efficiencies of various platform trial designs relative to a traditional two-arm strategy.
RESULTS
Platform trials can find beneficial treatments with fewer patients, fewer patient failures, less time, and with greater probability of success than a traditional two-arm strategy.
CONCLUSION
In an era of personalized medicine, platform trials provide the innovation needed to efficiently evaluate modern treatments.
背景
“平台试验”是一种采用单一主方案的临床试验，其中可同时评估多种治疗方法。适应性平台设计具有灵活的特点，例如因无效而放弃某些治疗方法、宣布一种或多种治疗方法更优，或者在试验过程中增加新的待测试治疗方法。
方法
一项模拟研究探讨了各种平台试验设计相对于传统双臂策略的效率。
结果
与传统双臂策略相比，平台试验能够以更少的患者、更少的患者失败、更短的时间以及更高的成功概率找到有益的治疗方法。
结论
在个性化医疗时代，平台试验提供了有效评估现代治疗方法所需的创新。
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