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| Wieloośrodkowe badanie kliniczne fazy I× | Bayesowska faza I badania klinicznego× | |
|---|---|---|
| Dziedzina | Epidemiologia | Epidemiologia |
| Rodzina | Process / pipeline | Process / pipeline |
| Rok powstania≠ | 1970s–1980s (formalized in FDA Phase I guidance 1977; ICH E6 GCP 1996) | 1990 |
| Twórca≠ | Established through FDA regulatory guidance and ICH harmonization frameworks | O'Quigley, Pepe & Fisher (Continual Reassessment Method) |
| Typ≠ | Interventional clinical study design | Adaptive Bayesian dose-finding design |
| Źródło pierwotne≠ | International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (2016). ICH Harmonised Guideline: Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). ICH. link ↗ | 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 ↗ |
| Inne nazwy | multisite Phase I trial, multi-institutional Phase I study, Phase I dose-escalation multicenter study, first-in-human multicenter trial | Bayesian dose-finding trial, CRM trial, continual reassessment method trial, Bayesian dose-escalation study |
| Pokrewne≠ | 6 | 5 |
| Podsumowanie≠ | A multicenter Phase I clinical trial is the first systematic administration of an investigational agent to humans, conducted simultaneously across two or more clinical sites. Its primary objectives are to characterize the safety and tolerability profile of the intervention, determine the maximum tolerated dose (MTD), and describe pharmacokinetic and pharmacodynamic behavior. Distributing enrollment across sites increases participant accrual speed and enhances the generalizability of early-phase safety data. | 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. |
| ScholarGateZbiór danych ↗ |
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