Textbook of Clinical Trials in Oncology: A Statistical Perspective

ISBN-13: 9781138083776 / Angielski / Twarda / 2019 / 626 str.

Susan Halabi; Stefan Michiels

Opis

This is a textbook on the design and analysis of cancer clinical trials. It opens with a discussion of the choice of endpoints before moving onto discuss various types of trials across all phases of study, including basket trials, non-inferiority trials and multi-arm trials.

Spis treści

The need for this book. Selection of endpoints. Co-primary Endpoints. Surrogate Endpoints. Innovative Phase I. Phase II. Phase II Biomarker, basket trials. Sample Size for phase III. Multi-Arm trials. Non-inferiority trials. Cure Rate. Design and Analysis of Immunotherapy Trials Data Monitoring Superiorirty and Futility Monitoring. Competing Risks. Missing Data. Multiple Comparison. Biomarker-based clinical trials. Adaptive designs. Trials designs for rare diseases in oncology. Prognostic Models. Validation Approaches. Identification of Predictive Markers. Subgroup Analysis. Statistical Issues in Genomic Studies. Developing and Validation of Signature