Methoden vergleichen

	Risikoadaptierte Phase-I-Klinikstudie	Adaptive Phase I Clinical Trial
Fachgebiet	Epidemiologie	Epidemiologie
Familie	Process / pipeline	Process / pipeline
Entstehungsjahr	1990s–2000s	1990 (model-based adaptive era); rule-based designs from the 1970s–1980s
Urheber	Evolved from the Continual Reassessment Method (O'Quigley et al., 1990) extended with patient-level risk covariates	O'Quigley, Pepe, and Fisher (CRM); earlier rule-based 3+3 designs pre-date it
Typ	Interventional clinical trial design	Adaptive clinical trial design
Wegweisende Quelle	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.
Aliasnamen	risk-stratified Phase I trial, risk-adaptive dose-escalation study, covariate-adjusted Phase I study, risk-based dose-finding trial	adaptive dose-escalation trial, adaptive dose-finding study, model-based adaptive Phase I design
Verwandt	5	1
Zusammenfassung	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.	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.