(PDF) Textbook of Clinical Trials in Oncology by Susan Halabi

This is the PDF eBook version for Textbook of Clinical Trials in Oncology – A Statistical Perspective by Susan Halabi, Stefan Michiels

Table of Contents

Section I Introduction

Introduction to Clinical Trials – Susan Halabi, Stefan Michiels

Section II General Issues

Selection of Endpoints – Katherine S Panageas and Andrea Knezevic

Section III Early Development

Innovative Phase I Trials – Cody Chiuzan and Nathaniel O’Connell

Section IV Middle Development

Current Issues in Phase II Cancer Clinical Trials – Sin-Ho Jung

Design and Analysis of Immunotherapy Clinical Trials – Megan Othus

Adaptive Designs – William T. Barry

Section V Late Phase Clinical Trials

Sample Size Calculations for Phase III Trials in Oncology – Koji Oba, Aye Kuchiba

Non-inferiority Trial – Keyue Ding, Chris O’Callaghan

Design of Multi-arm, Multi-stage Trials in Oncology – James Wason

Multiple Comparisons, Multiple Primary Endpoints and Subpopulation Analysis – Ekkehard Glimm, Dong Xi, Paul Gallo

Cluster Randomized Trials – Catherine M. Crespi

Statistical Monitoring of Safety and Efficacy – Jay Herson, Chen Hu

Section VI Personalized Medicine

Biomarker-Based Phase II and III Clinical Trials in Oncology – Shigeyuki Matsui, Masataka Igeta, Kiichiro Toyoizumi

Genomic Biomarker Clinical Trial Designs – Richard Simon

Trial designs for rare diseases and small samples in oncology – Robert A. Beckman, Cong Chen, Martin Posch and Sarah Zohar

Statistical Methods for Biomarker and Subgroup Evaluation in Oncology Trials – Ilya Lipkovich, Alex Dmitrienko, Bohdana Ratitch

Developing and Validating Prognostic Models of Clinical Outcomes – Susan Halabi, Lira Pi, and Chen-Yen Lin

High-Dimensional Penalized Regression Models in Time-to-Event Clinical Trials – Federico Rotolo, Nils Ternes, Stefan Michiels

Sequential Multiple Assignment Randomized Trials – Kelly Speth, Kelley M. Kidwell

Section VII Advanced Topics

Assessing the value of surrogate endpoints – Xavier Paoletti, Federico Rotolo, Stefan Michiels

Competing Risks – Aurelien Latouche, Gang Li, Qing Yang

Cure models in cancer clinical trials – Catherine Legrand, Aurelie Bertrand

Interval Censoring – Yuan Wu

Methods for analysis of trials with changes from randomised treatment – Nicholas R. Latimer and Ian R. White

The analysis of adverse events in randomized clinical trials – Jan Beyersmann, Claudia Schmoor

Analysis of quality of life outcomes in oncology trials – Stephen Walters

Missing Data – Stephanie Pugh, James J. Dignam, Juned Siddique