A Statistical Framework for Quantile Equivalence Clinical Trials with Application to Pharmacokinetic Studies that Bridge from HIV‐Infected Adults to Children

DOI10.1111/J.1541-0420.2007.00982.XMaRDI QIDQ3549403zbMATH OpenOpenAlexWikidataFDO

Authors Li-Xia Pei, Michael D. Hughes

Publication date 22 December 2008

Published in Biometrics (Search for Journal in Brave)

Full work available at URL https://doi.org/10.1111/j.1541-0420.2007.00982.x

zbMATH Keywords

bridging clinical trialsclinical trial design

Mathematics Subject Classification ID

Bayesian inference (62F15) Applications of statistics to biology and medical sciences; meta analysis (62P10) Medical applications (general) (92C50)

Recommendations

• Efficiency of bridging between related dose finding studies
• Dynamic calibration of pharmacokinetic parameters in dose-finding studies
• Sample size requirements for evaluation of bridging evidence
• Design and analysis of bridging studies with prior probabilities on the null and alternative hypotheses
• A Group Sequential Approach to Evaluation of Bridging Studies

Cites work

• Continual Reassessment Method: A Practical Design for Phase 1 Clinical Trials in Cancer
• scientific article; zbMATH DE number 1945302 (Why is no real title available?)
• Parameterization and Bayesian Modeling

Cited in

(3)

• Dynamic calibration of pharmacokinetic parameters in dose-finding studies
• Asymmetric inner wedge group sequential tests with applications to verifying whether effective drug concentrations are similar in adults and children
• Sequential monitoring of phase I dose expansion cohorts

Describes a project that uses

Uses Software

• WinBUGS

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