A review of phase 2-3 clinical trial designs

DOI10.1007/S10985-007-9049-XMaRDI QIDQ1029784zbMATH OpenOpenAlexWikidataFDO

Authors Peter F. Thall

Publication date 13 July 2009

Published in Lifetime Data Analysis (Search for Journal in Brave)

Full work available at URL https://doi.org/10.1007/s10985-007-9049-x

zbMATH Keywords

selectionadaptive designsphase II clinical trialsphase III clinical trials

Mathematics Subject Classification ID

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

Recommendations

• Seamlessly expanding a randomized phase II trial to phase III
• A comparison of methods for constructing confidence intervals after phase II/III clinical trials
• Confirmatory seamless phase II/III clinical trials with hypotheses selection at interim: opportunities and limitations
• Adaptive designs for binary treatment responses in phase III clinical trials: controversies and progress
• A three-stage Bayesian adaptive phase I/II design and simulation studies

Cites work

• scientific article; zbMATH DE number 1348603 (Why is no real title available?)
• scientific article; zbMATH DE number 1984442 (Why is no real title available?)
• A Two-Stage Design for Choosing among Several Experimental Treatments and a Control in Clinical Trials
• Designs for Group Sequential Phase II Clinical Trials
• Dose-Finding Based on Efficacy-Toxicity Trade-Offs
• Incorporating Toxicity Considerations Into the Design of Two-Stage Phase II Clinical Trials
• One-Sample Multiple Testing Procedure for Phase II Clinical Trials
• Optimal Designs for a Grouped Sequential Binomial Trial
• Optimal Dynamic Treatment Regimes
• Phase 2 and 3 Combination Designs to Accelerate Drug Development
• Practical Bayesian Guidelines for Phase IIB Clinical Trials
• Seamlessly expanding a randomized phase II trial to phase III
• Selecting Therapeutic Strategies Based on Efficacy and Death in Multicourse Clinical Trials
• Two-stage selection and testing designs for comparative clinical trials

Cited in

(9)

• Impacts on type I error rate with inappropriate use of learn and confirm in confirmatory adaptive design trials
• Discussion on “A Hybrid Selection and Testing Procedure with Curtailment for Comparative Clinical Trials” by Elena M. Buzaianu and Pinyuen Chen
• Hybrid design evaluating new biomarkers when there is an existing screening test
• Methodology and application of adaptive and sequential approaches in contemporary clinical trials
• Phase 2 and 3 Combination Designs to Accelerate Drug Development
• Multiple targeted therapies: is there a place for Vach type-3 or type-4 design trials
• Group-sequential response-adaptive designs for multi-armed trials
• A hybrid geometric phase II/III clinical trial design based on treatment failure time and toxicity
• Interphase Clinical Trials: Phase III/Phase IV

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