Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials

ISBN-13: 9781032093505 / Angielski / Miękka / 2021 / 376 str.

John Balser; Jim Roach; Robin Bliss

Opis

Clinical trials require strategic thinking and innovative methods since some traditional methods are not adequate for the 21st century.To solve these problems requires good methodological skills, but also an in-depth knowledge of the practical problems we are dealing with and a strategic vision of the pig picture.

Spis treści

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.

O autorze

Mark Chang, John Balser, Jim Roach, Robin Bliss