Adaptive Design Methods in Clinical Trials

Adaptive Design Methods in Clinical Trials

Chang, Mark; Chow, Shein-Chung

Taylor & Francis Ltd

01/2023

374

Mole

Inglês

9781032477602

15 a 20 dias

690

Descrição não disponível.
Introduction. Protocol Amendment. Adaptive Randomization. Adaptive Hypotheses. Adaptive Dose-Escalation Trials. Adaptive Group Sequential Design. Statistical Tests for Seamless Adaptive Designs. Adaptive Sample Size Adjustment. Two-Stage Adaptive Design. Adaptive Treatment Switching. Bayesian Approach. Biomarker Adaptive Trials. Target Clinical Trials. Sample Size and Power Estimation. Clinical Trial Simulation. Regulatory Perspectives - A Review of FDA Draft Guidance. Case Studies. Bibliography. Subject Index.
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Interim Analysis;Adaptive Design;FDA draft guidance on adaptive clinical trial designs;Sample Size Calculation;adaptive designs in clinical trials;Sample Size Re-estimation;clinical trial simulation;Group Sequential Design;protocol amendments on clinical trial designs;Adaptive Design Methods;adaptive dose-escalation design;two-stage adaptive design;Adaptive Group Sequential Design;biomarker adaptive trials;Adaptive Seamless Designs;adaptive group sequential designs;Noninferiority Margin;genomic-guided clinical trials;Expected Sample Size;Bayesian Optimal Adaptive Designs;Adaptive Trial Designs;Seamless Design;Progressive Disease;RAR;Study Endpoint;Stopping Boundaries;Group Sequential Trial;Target Clinical Trials;Ter;Stopping Boundary;Confirmatory Phase;Target Patient Population;Actual Patient Population;Protocol Amendments