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

DOI10.1002/BIMJ.201600084zbMATH Open1369.62307OpenAlexW2599040148WikidataQ40283645 ScholiaQ40283645MaRDI QIDQ5280197FDOQ5280197

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)

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

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

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)

Cites Work

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

Cited In (5)

• Bayesian dose regimen assessment in early phase oncology incorporating pharmacokinetics and pharmacodynamics
• 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

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