CRC HDBK STATS CLINICAL ONCOL PDF

Preface

The second edition expands the first as a compendium of current statistical approaches to problems facing cancer researchers. During the five years since the first edition of the book appeared, there has been an explosion in the technological capabilities of genomic and proteomic research, which is now firmly implanted in cancer research. This has necessitated the addition of a new section devoted to analysis of high throughput data and bioinformatics. Previous sections of the first edition have been revised to reflect the current state of the art. As in the first edition, the intended audience is primarily statisticians working in cancer and more generally in any discipline of medicine. But it is hoped that oncologists too would find the material accessible and benefit from a rudimentary understanding of the fundamental concepts laid forth in each chapter.

The second edition contains six sections:

1. Phase I Trials. Updated recommendations regarding the standard 3-cohort and continual reassessment approaches along with a new chapter on the design and analysis of pharmacokinetic studies are provided.

2. Phase II Trials. Current experience in designs based on toxicity and response, time to events, selection of therapies for phase III, and innovative ways to combine single-arm phase II experiments are discussed.

3. Phase III Trials. A comprehensive treatment is provided of sample size, factorial designs, and noninferiority studies along with analyses of outcomes and economic endpoints.

4. Prognostic Factors and Exploratory Analysis. Essential guidelines and caveats for inferring effects and accounting for covariates for survival analysis are illustrated through a wealth of examples.

5. Bioinformatics and High-Throughput Data. Analyses of genomic microarray, proteomic, single nucleotide polymorphisms, haplotypes, and general features of high-dimensional data are provided, along with a valuable guide to free software.

6. Interpreting Clinical Trials. This section continues to emphasize the lessons and pitfalls on what can and cannot be concluded from single or multiple clinical trials.