Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials
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Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials
Roach, Jim; Balser, John; Bliss, Robin; Chang, Mark
Taylor & Francis Inc
03/2019
376
Dura
Inglês
9780815379447
15 a 20 dias
816
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Overview of Drug Development. Introduction to Clinical Trials. Basics of Therapeutic Areas. Strategical Clinical Development Plan. Practical Multiple Testing Procedures. Two-Sample Fisher and Barnard Exact Test Methods. Guidance for Survival Analysis. Survival Analysis Method with Delayed Treatment Effect. Multistage Survival Models for Treatment Switching. Two-Stage Group Sequential Design. Two-Stage Sample-Size Re-Estimation Design. Two-Stage Pick-the-Winner Design (Seamless Design). Two-Stage Biomarker-Enrichment Design. Rerandomization Design at Progressive Disease for Cancer Trials-Sequential Parallel Comparison Design. Predicting Treatment Effects using Blinded Interim Result. Two-Stage Adaptive Design with Multiple Endpoints. Optimal Phase-II and Phase-III Trial Strategy. Regulatory Guidance on Adaptive Design. Trial Design with Mixture Paired and Unpaired Data. Trial Design with Competing Risks. Ranked Composite Endpoint and Coprimary Endpoints. Noninferiority Trial Design using Simulation. Dose Escalation Design with Binomial and Trinomial Models. Special Issues in Single-Arm Trial Design. Subgroup Analysis and Multiple Regional Studies. Adaptive Trial Interim Analysis and Adaptation. Practical Approach to Handling of Missing Data. Confidence Interval Calculations. Controversies and Challenges in Pharmaceutical Statistics. Analysis of Adverse Event Burden. Hidden Confounders.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Sample Size Re-estimation;Sample Size Reestimation;Adaptive Designs;CDP Modeling;Multiple Testing;SAS Macro;Sample Size;Interim Analysis;Dose Finding;ADAS Cog;Pharmaceutical Statistics;Drop Loser Design;Drug Development;Adaptive Signature Design;clinical trial simulations;Co-primary Endpoints;Coprimary Endpoints;innovative approach;Biomarker Positive Patients;statistical methods;Adaptive Design;Weighted LogRank Test;PD;DMC Member;Missing Data;Phase Transition Probabilities;Stopping Boundaries;Barnard's Test;Proc Print Data;Biomarker Negative Patients;Error Spending Function;DMC Charter;Clinical Development Program;Smart
Overview of Drug Development. Introduction to Clinical Trials. Basics of Therapeutic Areas. Strategical Clinical Development Plan. Practical Multiple Testing Procedures. Two-Sample Fisher and Barnard Exact Test Methods. Guidance for Survival Analysis. Survival Analysis Method with Delayed Treatment Effect. Multistage Survival Models for Treatment Switching. Two-Stage Group Sequential Design. Two-Stage Sample-Size Re-Estimation Design. Two-Stage Pick-the-Winner Design (Seamless Design). Two-Stage Biomarker-Enrichment Design. Rerandomization Design at Progressive Disease for Cancer Trials-Sequential Parallel Comparison Design. Predicting Treatment Effects using Blinded Interim Result. Two-Stage Adaptive Design with Multiple Endpoints. Optimal Phase-II and Phase-III Trial Strategy. Regulatory Guidance on Adaptive Design. Trial Design with Mixture Paired and Unpaired Data. Trial Design with Competing Risks. Ranked Composite Endpoint and Coprimary Endpoints. Noninferiority Trial Design using Simulation. Dose Escalation Design with Binomial and Trinomial Models. Special Issues in Single-Arm Trial Design. Subgroup Analysis and Multiple Regional Studies. Adaptive Trial Interim Analysis and Adaptation. Practical Approach to Handling of Missing Data. Confidence Interval Calculations. Controversies and Challenges in Pharmaceutical Statistics. Analysis of Adverse Event Burden. Hidden Confounders.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
Sample Size Re-estimation;Sample Size Reestimation;Adaptive Designs;CDP Modeling;Multiple Testing;SAS Macro;Sample Size;Interim Analysis;Dose Finding;ADAS Cog;Pharmaceutical Statistics;Drop Loser Design;Drug Development;Adaptive Signature Design;clinical trial simulations;Co-primary Endpoints;Coprimary Endpoints;innovative approach;Biomarker Positive Patients;statistical methods;Adaptive Design;Weighted LogRank Test;PD;DMC Member;Missing Data;Phase Transition Probabilities;Stopping Boundaries;Barnard's Test;Proc Print Data;Biomarker Negative Patients;Error Spending Function;DMC Charter;Clinical Development Program;Smart
