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Essai clinique de phase III à risque ajusté×Essai clinique randomisé adaptatif×
DomaineÉpidémiologieÉpidémiologie
FamilleProcess / pipelineProcess / pipeline
Année d'origine1980s–presentLate 1990s–2000s (widespread adoption post-2010)
Auteur d'origineEvolving practice; foundational risk-adjustment principles established by Pocock (1983) and extended by numerous trialistsDonald Berry and colleagues; formalized by FDA guidance in 2010 and 2019
TypeConfirmatory randomized trial with baseline risk stratification and covariate adjustmentExperimental clinical trial design
Source fondatricePocock, S. J. (1983). Clinical Trials: A Practical Approach. Wiley. ISBN: 978-0471901556Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. DOI ↗
Aliasrisk-stratified Phase III trial, covariate-adjusted Phase III RCT, risk-adjusted confirmatory trial, RA-Phase IIIadaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial
Apparentées66
RésuméA risk-adjusted Phase III clinical trial is a large-scale confirmatory randomized experiment that explicitly incorporates participants' baseline prognostic risk profile into both the randomization process and the primary statistical analysis. By stratifying patients on known risk factors before allocation and adjusting for those factors in the outcome model, the design achieves greater statistical precision, reduces confounding, and produces treatment effect estimates that are more clinically meaningful across patient subgroups.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.
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ScholarGateComparer des méthodes: Risk-adjusted Phase III clinical trial · Adaptive Randomized Clinical Trial. Consulté le 2026-06-19 sur https://scholargate.app/fr/compare