Dose-finding methods for phase I clinical trials using pharmacokinetics in small populations

DOI10.1002/BIMJ.201600084MaRDI QIDQ5280197zbMATH OpenOpenAlexWikidataFDO

Authors Moreno Ursino, Sarah Zohar, Frederike Lentz, Corinne Alberti, Tim Friede, Nigel Stallard, Emmanuelle Comets

Publication date 20 July 2017

Published in Biometrical Journal (Search for Journal in Brave)

Copyright license Creative Commons Attribution 4.0 International

Full work available at URL https://doi.org/10.1002/bimj.201600084

zbMATH Keywords

dose-findingphase I clinical trialsmaximum tolerated dosepharmacokineticsdose-toxicity relationship

Mathematics Subject Classification ID

Applications of statistics to biology and medical sciences; meta analysis (62P10)

Recommendations

• Pharmacokinetically guided optimum adaptive dose selection in early phase clinical trials
• Bayesian dose regimen assessment in early phase oncology incorporating pharmacokinetics and pharmacodynamics
• Random-effects meta-analysis of phase I dose-finding studies using stochastic process priors
• Patient-specific dose finding in phase I clinical trials
• Designs for Phase I Clinical Trials with Multiple Courses of Subjects at Different Doses

Cites work

• Combining Multiple Comparisons and Modeling Techniques in Dose‐Response Studies
• Continual Reassessment Method: A Practical Design for Phase 1 Clinical Trials in Cancer
• Easy-to-implement Bayesian methods for dose-escalation studies in healthy volunteers
• Statistical Methods for Dose‐Finding Experiments

Cited in

(8)

• Bayesian dose regimen assessment in early phase oncology incorporating pharmacokinetics and pharmacodynamics
• On inclusion of covariates in model based dose finding clinical trial designs
• Pharmacokinetically guided optimum adaptive dose selection in early phase clinical trials
• Bayesian modeling of a bivariate toxicity outcome for early phase oncology trials evaluating dose regimens
• A Bayesian time-to-event pharmacokinetic model for phase I dose-escalation trials with multiple schedules
• An extended Bayesian semi-mechanistic dose-finding design for phase I oncology trials using pharmacokinetic and pharmacodynamic information
• DEMO: dose exploration, monitoring, and optimization using biological and clinical outcomes
• A Comparative Analysis of Phase I Dose-Finding Designs Incorporating Pharmacokinetics Information

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