part Part I: Phase I Trials -- chapter 1 Overview of Phase I Trials / chapter 2 Phase I and Phase I/II Dose Finding Algorithms Using Continual Reassessment Method / chapter 3 Choosing a Phase I Design / chapter 4 Pharmacokinetics in Clinical Oncology: Statistical Issues / chapter 5 Practical Implementation of the Continual Reassessment Method / part Part II: Phase II Trials -- chapter 6 Overview of Phase II Clinical Trials / chapter 7 Designs Based on Toxicity and Response / chapter 8 Phase II Trials Using Time-to-Event Endpoints / chapter 9 Phase II Selection Designs / part Part III: Phase III Trials -- chapter 10 On Use of Covariates in Randomization and Analysis of Clinical Trials / chapter 11 Factorial Designs with Time to Event Endpoints / chapter 12 Noninferiority Trials / chapter 13 Power and Sample Size for Phase III Clinical Trials of Survival / chapter 14 Early Stopping of Cancer Clinical Trials / chapter 15 Design and Analysis of Quality of Life Data / chapter 16 Economic Analyses Alongside Cancer Clinical Trials / part Part IV: Exploratory Analyses and Prognostic Factors -- chapter 17 Prognostic Factor Studies / chapter 18 Statistical Methods to Identify Predictive Factors / chapter 19 Explained Variation in Proportional Hazards Regression -- chapter 20 Constructing Prognostic Groups by Tree-Based Partitioning and Peeling Methods / chapter 21 Clinical Monitoring Based on Joint Models for Longitudinal Biomarkers and Event Times / part Part V: High-Throughput Data and Bioinformatics -- chapter 22 Some Practical Considerations for Analysis of Spotted Microarray Data / chapter 23 Statistical Applications Using DNA Microarrays for Cancer Diagnosis and Prognosis / chapter 24 Profiling High-Dimensional Protein Expression Using MALDI-TOF: Mass Spectrometry for Biomarker Discovery / chapter 25 Statistical Approaches for High Dimensional Data Derived from High Throughput Assays: A Case Study of Protein Expression Levels in Lung Cancer / chapter 26 Spatial Modeling of Multilocus Data / chapter 27 Software for Genomic Data -- part Part VI: Interpreting Clinical Trials -- chapter 28 Bayesian Sensitivity Analyses of Confounded Treatment Effects / chapter 29 Interpreting Longitudinal Studies of QOL with Nonignorable Dropout / chapter 30 Estimation of Cumulative Incidence in the Presence of Competing Risks / chapter 31 Pitfalls in the Design, Conduct and Analysis of Randomized Clinical Trials / chapter 32 Dose-Intensity Analysis / chapter 33 Sequential Randomization