手法を比較

	実践的臨床試験	適応的試験デザイン
分野	臨床研究	臨床研究
系統	Process / pipeline	Process / pipeline
提唱年	2009-2015	1990s-2000s
提唱者	Thorpe et al. (2009); PRECIS framework developed by international consortia	Stephen Pocock, Christopher Jennison, and statistical methodologists; FDA formalized guidance 2019
種類	Research Design	Research Design
原典	Thorpe, K. E., Zwarenstein, M., Oxman, A. D., Treweek, S., Furberg, C. D., Altman, D. G., ... & Tugwell, P. (2009). A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ, 180(10), E47–E57.	Pocock, S. J. (2005). Current issues in the design and interpretation of clinical trials. BMJ, 330(7500), 1118–1121.
別名	pragmatic trial, real-world trial, effectiveness trial, PRECIS-2	adaptive trial, adaptive design, response-adaptive randomization, RAR
関連	4	1
概要	A pragmatic trial is designed to evaluate the real-world effectiveness of an intervention in typical clinical settings with diverse, representative patients, minimal exclusion criteria, and clinically relevant outcomes. Developed by Thorpe and colleagues (2009) and formalized via the PRECIS-2 framework (2015), pragmatic trials bridge the gap between explanatory efficacy trials (conducted in controlled research settings) and implementation science, answering the question 'Does this work in actual clinical practice?' rather than 'Can this work under ideal conditions?'	An adaptive trial design allows pre-specified modifications to the trial based on interim data—such as sample size re-estimation, stopping for futility or efficacy, dropping ineffective arms, or shifting randomization ratios toward better-performing treatments. Developed systematically in the 1990s–2000s by statisticians like Pocock and Jennison, and formalized by the FDA in 2019, adaptive designs accelerate drug development, reduce exposure to ineffective treatments, and improve efficiency without inflating false-positive rates when properly executed.