Порівняння методів

	Клінічне дослідження Фази I з урахуванням ризику	Байєсівський дизайн клінічного випробування Фази I
Галузь	Епідеміологія	Епідеміологія
Родина	Process / pipeline	Process / pipeline
Рік появи	1990s–2000s	1990
Автор методу	Evolved from the Continual Reassessment Method (O'Quigley et al., 1990) extended with patient-level risk covariates	O'Quigley, Pepe & Fisher (Continual Reassessment Method)
Тип	Interventional clinical trial design	Adaptive Bayesian dose-finding design
Основоположне джерело	Iasonos, A., Wilton, A. S., & Gonen, M. (2008). A review of stochastic dose-finding methods. Statistics in Medicine, 27(25), 5031–5046.	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.
Інші назви	risk-stratified Phase I trial, risk-adaptive dose-escalation study, covariate-adjusted Phase I study, risk-based dose-finding trial	Bayesian dose-finding trial, CRM trial, continual reassessment method trial, Bayesian dose-escalation study
Пов'язані	5	5
Підсумок	A risk-adjusted Phase I clinical trial is a first-in-human or dose-finding study that explicitly incorporates patient-level risk covariates — such as organ function, prior therapy, or genetic markers — into the dose-escalation model. Rather than treating all enrolled participants as homogeneous, the design accounts for individual differences in tolerance, allowing the recommended dose to vary by risk stratum. This approach is especially common in oncology, where patients with impaired renal function or heavily pre-treated disease may tolerate lower doses than the broader population.	A 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.