Textbook of Clinical Trials in Oncology

Susan Halabi, Ph.D. is Professor of Biostatistics and Bioinformatics, Duke University, USA. She has extensive experience in the design and analysis of clinical trials in oncology. Dr. Halabi is a fellow of the American Statistical Association, the Society of Clinical Trials, and the American Society of Clinical Oncology. She serves on the Oncologic Drugs Advisory Committee for the Food and Drug Administration. Stefan Michiels, Ph.D. is Head of the Oncostat team of the Center for research in epidemiology and population health (INSERM U1018, University Paris-Saclay, University Paris-Sud) at Gustave Roussy, Villejuif, France. His areas of expertise are clinical trials, meta-analyses and prediction models in oncology. Stefan is the currently the chair of the biostatisticians at Unicancer, a French collaborative cancer clinical trials group. Stefan holds a PhD in Biostatistics from the School of Public Health at the University Paris-Sud and Master Degrees in Statistics and in Applied Mathematics from the University of Leuven. His previous positions include the Université Libre de Bruxelles- Institut Jules Bordet (Belgium), the National Cancer Institute (France) and the University of Leuven (Belgium). He is currently member of the editorial board of the Journal of the National Cancer Institute and Annals of Oncology.

The need for this book. Selection of endpoints. Co-primary Endpoints. Surrogate Endpoints. Innovative Phase I. Phase II. Phase II Biomarker, basket trials. Sample Size for phase III. Multi-Arm trials. Non-inferiority trials. Cure Rate. Design and Analysis of Immunotherapy Trials Data Monitoring Superiorirty and Futility Monitoring. Competing Risks. Missing Data. Multiple Comparison. Biomarker-based clinical trials. Adaptive designs. Trials designs for rare diseases in oncology. Prognostic Models. Validation Approaches. Identification of Predictive Markers. Subgroup Analysis. Statistical Issues in Genomic Studies. Developing and Validation of Signature