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 Regulatory Perspectives - A Review of FDA Draft Guidance.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;group;Adaptive Design;sequential;Sample Size Calculation;designs;Sample Size Re-estimation;Group Sequential Design;interim;Adaptive Design Methods;analysis;Clinical Trial Simulation;sample;Adaptive Group Sequential Design;size;Adaptive Seamless Designs;Noninferiority Margin;hypothesis;test;Expected Sample Size;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
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 Regulatory Perspectives - A Review of FDA Draft Guidance.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.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Interim Analysis;group;Adaptive Design;sequential;Sample Size Calculation;designs;Sample Size Re-estimation;Group Sequential Design;interim;Adaptive Design Methods;analysis;Clinical Trial Simulation;sample;Adaptive Group Sequential Design;size;Adaptive Seamless Designs;Noninferiority Margin;hypothesis;test;Expected Sample Size;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