Mark Chang, John Balser, Jim Roach, Robin Bliss

Innovative Strategies, Statistical Solutions and Simulations for Modern Clinical Trials (eBook, PDF)

• Format: PDF

Produktbeschreibung

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.

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 376
• Erscheinungstermin: 20. März 2019
• Englisch
• ISBN-13: 9781351214537
• Artikelnr.: 56060301

Autorenporträt

Mark Chang, John Balser, Jim Roach, Robin Bliss

Inhaltsangabe

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.