Handbook of Statistics in Clinical Oncology PDF

Preface

This third edition expands on the first and second editions as a compilation of statistical topics relevant to cancer research in general, and to oncology clinical trials and translational research in particular. Since the last edition, published in 2006, many new challenges have arisen in this area. New cancer therapies are often based on cytostatic or targeted agents, which pose new challenges in the design and analysis of all phases of oncology clinical trials. New chapters specifically addressing trial design issues pertaining to targeted agents have been added. The literature on adaptive trial designs and early stopping has been exploding, and new chapters on these topics have been added. Inclusion of high-dimensional data and imaging techniques have become common practice in oncology clinical trials, and statistical methods on how to analyze such data have been refined in this area. Many tools have become available to help statisticians design clinical trials, and a chapter has been added to review these tools and to provide a reference on where to find them. In addition, previous sections of the second edition have been revised to reflect the current state of the art. As in the first two editions, the intended audience is primarily statisticians and other researchers involved in designing and analyzing cancer clinical trials. Experts in the field have contributed individual chapters making this an invaluable reference.

This third edition is divided into four parts:

1. Phase I Trials. Updated recommendations regarding the standard 3 + 3 and continual reassessment approaches along with new chapters on phase 0 trials and on phase I trial design for targeted agents are provided.

2. Phase II Trials. Current experience in single-arm and randomized phase II trial designs has been updated. New chapters added to this part include phase II designs with multiple strata and phase II/III designs.

3. Phase III Trials. Many new chapters have been added to this part, including interim analyses and early stopping considerations, phase III trial designs for targeted agents and for testing the ability of markers, adaptive trial designs, cure-rate survival models, statistical methods of imaging, as well as a thorough review of software for the design and analysis of clinical trials.

4. Exploratory and High-Dimensional Data Analyses. All chapters in this part have been thoroughly updated since the last edition. New chapters have been added to address methods for analyzing SNP data and for developing a score based on gene expression data. In addition, chapters on risk calculators and forensic bioinformatics have been added to this part.