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| Risikoadaptierte Phase-I-Klinikstudie× | Randomisierte klinische Studie (RCT)× | |
|---|---|---|
| Fachgebiet | Epidemiologie | Epidemiologie |
| Familie | Process / pipeline | Process / pipeline |
| Entstehungsjahr≠ | 1990s–2000s | 1948 (first rigorously conducted RCT — MRC streptomycin trial) |
| Urheber≠ | Evolved from the Continual Reassessment Method (O'Quigley et al., 1990) extended with patient-level risk covariates | Austin Bradford Hill; MRC Streptomycin Trial team |
| Typ≠ | Interventional clinical trial design | Interventional experimental study |
| Wegweisende Quelle≠ | Iasonos, A., Wilton, A. S., & Gonen, M. (2008). A review of stochastic dose-finding methods. Statistics in Medicine, 27(25), 5031–5046. link ↗ | Friedman, L. M., Furberg, C. D., DeMets, D. L., Reboussin, D. M., & Granger, C. B. (2015). Fundamentals of Clinical Trials (5th ed.). Springer. ISBN: 978-3319185385 |
| Aliasnamen | risk-stratified Phase I trial, risk-adaptive dose-escalation study, covariate-adjusted Phase I study, risk-based dose-finding trial | RCT, randomized controlled trial, randomised controlled trial, clinical randomized trial |
| Verwandt≠ | 5 | 6 |
| 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. | A randomized clinical trial (RCT) is an experimental study design in which participants are randomly assigned to an intervention group or a control group, then followed prospectively to compare outcomes. Random allocation is the defining feature: it distributes known and unknown confounders across groups by chance, making the RCT the strongest individual study design for establishing causal efficacy of a treatment or intervention under controlled conditions. |
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