手法を比較

	多施設共同第II相臨床試験	フェーズIII臨床試験
分野	疫学	疫学
系統	Process / pipeline	Process / pipeline
提唱年	1970s–1980s (formalized in regulatory guidance; Simon two-stage design 1989)	1962 (Kefauver-Harris Amendment formalised phased drug development)
提唱者	Established through ICH and FDA regulatory frameworks; Simon two-stage design formalized by Richard Simon (1989)	FDA regulatory framework / ICH guidelines
種類	Interventional clinical trial design	Confirmatory randomised controlled trial
原典	International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (2009). ICH Harmonised Tripartite Guideline: General Considerations for Clinical Studies E8(R1). ICH.	Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385
別名	multi-site phase II trial, phase 2 multicenter study, multicenter Phase IIA/IIB trial, multisite efficacy trial	Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT
関連	6	6
概要	A multicenter phase II clinical trial is an interventional study conducted at two or more independent clinical sites to evaluate the preliminary efficacy and safety of a new treatment in a defined patient population, following demonstrated tolerability in phase I. By pooling patients across sites, the design achieves the sample sizes needed to estimate response rates and identify promising signals before committing to the larger investment of a phase III confirmatory trial.	A Phase III clinical trial is a large-scale, confirmatory randomised controlled trial designed to establish the efficacy and safety of an intervention in the target patient population before regulatory submission. It builds on the signal identified in Phase II, tests the intervention at its proposed dose under controlled conditions, and provides the primary evidence base for marketing authorisation or guideline adoption.