Comparer des méthodes

	Essai clinique de phase III	Essai clinique randomisé adaptatif
Domaine	Épidémiologie	Épidémiologie
Famille	Process / pipeline	Process / pipeline
Année d'origine	1962 (Kefauver-Harris Amendment formalised phased drug development)	Late 1990s–2000s (widespread adoption post-2010)
Auteur d'origine	FDA regulatory framework / ICH guidelines	Donald Berry and colleagues; formalized by FDA guidance in 2010 and 2019
Type	Confirmatory randomised controlled trial	Experimental clinical trial design
Source fondatrice	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	Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36.
Alias	Phase 3 trial, confirmatory trial, pivotal trial, Phase III RCT	adaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial
Apparentées	6	6
Résumé	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.	An adaptive randomized clinical trial (adaptive RCT) is a prospective experimental study that uses pre-specified rules to modify one or more trial aspects — such as sample size, allocation ratios, or treatment arms — based on accumulating data collected during the trial itself, while maintaining statistical validity and integrity of the study.