A Parallel Phase I/II Clinical Trial Design for Combination Therapies

DOI10.1111/J.1541-0420.2006.00685.XMaRDI QIDQ5459586zbMATH OpenOpenAlexWikidataFDO

Authors Xuelin Huang, Swati Biswas, Yasuhiro Oki, Jean-Pierre Issa, Donald A. Berry

Publication date 29 April 2008

Published in Biometrics (Search for Journal in Brave)

Full work available at URL https://doi.org/10.1111/j.1541-0420.2006.00685.x

zbMATH Keywords

logistic regressionefficacysynergytoxicitydose selection

Mathematics Subject Classification ID

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

Recommendations

• A three-stage Bayesian adaptive phase I/II design and simulation studies
• A Bayesian seamless phase I–II trial design with two stages for cancer clinical trials with drug combinations
• Bayesian phase I/II adaptively randomized oncology trials with combined drugs
• Bayesian designs for phase I--II clinical trials
• A Bayesian adaptive design for addressing correlated late-onset outcomes in phase I/II randomized trials of drug combinations in oncology

Cites work

• Bayesian statistics and the efficiency and ethics of clinical trials
• Design and Analysis of Phase I Clinical Trials
• Designs for Single- or Multiple-Agent Phase I Trials
• Dose-finding with two agents in phase I oncology trials
• Seamlessly expanding a randomized phase II trial to phase III
• The Randomized Play-the-Winner Rule in Medical Trials
• Two‐Dimensional Dose Finding in Discrete Dose Space

Cited in

(11)

• A multi‐source adaptive platform design for testing sequential combinatorial therapeutic strategies
• A Bayesian phase I/II trial design for immunotherapy
• Making Efficient Use of Patients in Designing Phase III Trials Investigating Simultaneously a Set of Targeted Therapies with Different Targets
• A three-stage Bayesian adaptive phase I/II design and simulation studies
• Continual reassessment method for partial ordering
• A Latent Contingency Table Approach to Dose Finding for Combinations of Two Agents
• A prospective combination of phase II and phase III in drug development
• Phase 2 and 3 Combination Designs to Accelerate Drug Development
• Semiparametric Dose Finding Methods for Partially Ordered Drug Combinations
• Bayesian phase I/II adaptively randomized oncology trials with combined drugs
• Dual-agent dose-finding in phase I clinical trial -- an extension of rapid enrollment design

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