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Ujian Klinikal Fasa I Bayesian×Ujian Klinikal Fasa I Adaptif×
BidangEpidemiologiEpidemiologi
KeluargaProcess / pipelineProcess / pipeline
Tahun asal19901990 (model-based adaptive era); rule-based designs from the 1970s–1980s
PengasasO'Quigley, Pepe & Fisher (Continual Reassessment Method)O'Quigley, Pepe, and Fisher (CRM); earlier rule-based 3+3 designs pre-date it
JenisAdaptive Bayesian dose-finding designAdaptive clinical trial design
Sumber perintisO'Quigley, J., Pepe, M., & Fisher, L. (1990). Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics, 46(1), 33–48. DOI ↗O'Quigley, J., Pepe, M., & Fisher, L. (1990). Continual reassessment method: a practical design for phase 1 clinical trials in cancer. Biometrics, 46(1), 33–48. DOI ↗
AliasBayesian dose-finding trial, CRM trial, continual reassessment method trial, Bayesian dose-escalation studyadaptive dose-escalation trial, adaptive dose-finding study, model-based adaptive Phase I design
Berkaitan51
RingkasanA Bayesian Phase I clinical trial uses prior probability models and sequential Bayes updating to find the maximum tolerated dose (MTD) of a new agent. Unlike the traditional 3+3 rule-based escalation, the Bayesian approach revises a dose-toxicity curve continuously as each patient's outcome is observed, allowing faster convergence to the true MTD while minimising exposure of patients to unsafe or subtherapeutic doses.An adaptive Phase I clinical trial is a first-in-human or early-phase dose-finding study that continuously updates the recommended dose after each patient cohort using a prespecified statistical model, rather than following a fixed rule. The goal is to identify the maximum tolerated dose (MTD) or the recommended Phase II dose (RP2D) efficiently while minimising exposure of participants to sub-therapeutic or toxic doses. Adaptive designs — most notably the Continual Reassessment Method (CRM) — replace or augment traditional rule-based designs such as the 3+3 schema.
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ScholarGateBandingkan kaedah: Bayesian Phase I clinical trial · Adaptive Phase I Clinical Trial. Dicapai 2026-06-19 daripada https://scholargate.app/ms/compare