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Ujian Klinikal Fasa III Multilokasi×Ujian Klinikal Rawak Adaptif×
BidangEpidemiologiEpidemiologi
KeluargaProcess / pipelineProcess / pipeline
Tahun asal1940s–1990s (formalized through ICH harmonization ~1990s)Late 1990s–2000s (widespread adoption post-2010)
PengasasCodified through ICH E9 guideline (1998) and decades of regulatory practice (FDA, EMA)Donald Berry and colleagues; formalized by FDA guidance in 2010 and 2019
JenisConfirmatory interventional study designExperimental clinical trial design
Sumber perintisFriedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385Berry, D. A. (2006). Bayesian clinical trials. Nature Reviews Drug Discovery, 5(1), 27–36. DOI ↗
AliasPhase III multicenter RCT, confirmatory multicenter trial, Phase 3 multicenter study, pivotal multicenter trialadaptive RCT, adaptive trial design, response-adaptive randomization trial, adaptive clinical trial
Berkaitan66
RingkasanA multicenter Phase III clinical trial is the definitive confirmatory study that tests whether a new intervention produces a clinically meaningful benefit over a comparator in a large, representative patient population enrolled at two or more independent research sites. It is the primary evidence basis for regulatory approval by agencies such as the FDA and EMA, combining the statistical power of large samples with the external validity gained from geographic and demographic diversity across sites.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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ScholarGateBandingkan kaedah: Multicenter Phase III Clinical Trial · Adaptive Randomized Clinical Trial. Dicapai 2026-06-19 daripada https://scholargate.app/ms/compare