ABSTRACT
Many new challenges have arisen in the area of oncology clinical trials. New cancer therapies are often based on cytostatic or targeted agents, which pose new challenges in the design and analysis of all phases of trials. The literature on adaptive trial designs and early stopping has been exploding. Inclusion of high-dimensional data and imaging t
Choosing a Phase I Design. Dose Finding Designs Based on the Continual Reassessment Method. Pharmacokinetics in Clinical Oncology: Statistical Issues. Statistics of Phase 0 Trials. CRM Trials for Assessing Toxicity and Efficacy. Seamless Phase I/II Trial Design for Assessing Toxicity and Efficacy for Targeted Agents. Overview of Phase II Clinical Trials. Designs Based on Toxicity and Response. Designs Using Time to Event Endpoints/Single Arm versus Randomized Phase II. Phase II Selection Designs. Phase II with Multiple Subgroups: Designs Incorporating Disease Subtype or Genetic Heterogeneity. Phase II/III Designs. On Use of Covariates in Randomization and Analysis of Clinical Trials. Factorial Designs with Time to Event Endpoints. Early Stopping of Clinical Trials. Noninferiority Trials. Phase III Trials for Targeted Agents. Adaptive Trial Designs. Design of a Clinical Trial for Testing the Ability of a Continuous Marker to Predict Therapy Benefit. Software for Design and Analysis of Clinical Trials. Cure-Rate Survival Models in Clinical Trials. Design and Analysis of Quality of Life Data. Economic Analyses alongside Cancer Clinical Trials. Structural and Molecular Imaging in Cancer Therapy Clinical Trials. Prognostic Factor Studies. Predictive Modeling of Gene Expression Data. Explained Variation and Explained Randomness for Proportional Hazards Models. Prognostic Groups by Tree-Based Partitioning and Data Refinement Methods. Risk Calculators. Developing a Score Based upon Gene Expression Profiling and Validation. Analysis of DNA Microarrays. Methods for SNP Regression Analysis in Clinical Studies: Selection, Shrinkage, and Logic. Forensic Bioinformatics. Index.
