手法を比較

	リスク調整型第I相臨床試験	用量反応分析
分野	疫学	疫学
系統	Process / pipeline	Process / pipeline
提唱年	1990s–2000s	Conceptual roots 16th century; modern epidemiological application mid-20th century
提唱者	Evolved from the Continual Reassessment Method (O'Quigley et al., 1990) extended with patient-level risk covariates	Paracelsus (conceptual foundation); formalized by John Snow and later Bradford Hill
種類	Interventional clinical trial design	Quantitative analytical method
原典	Iasonos, A., Wilton, A. S., & Gonen, M. (2008). A review of stochastic dose-finding methods. Statistics in Medicine, 27(25), 5031–5046.	Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641
別名	risk-stratified Phase I trial, risk-adaptive dose-escalation study, covariate-adjusted Phase I study, risk-based dose-finding trial	exposure-response analysis, concentration-response modeling, dose-response modeling, DRA
関連	5	4
概要	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.	Dose-response analysis quantifies the relationship between the magnitude of an exposure (the dose) and the probability or rate of an outcome (the response). It is a core analytical strategy in epidemiology and toxicology, providing evidence that increasing exposure systematically increases — or decreases — the risk of disease. A demonstrated dose-response gradient is one of Bradford Hill's classic criteria supporting causal inference.