This is a practical guide to the design, conduction, analysis and reporting of clinical trials with anticancer drugs. It includes coverage of basic biostatistics for the clinical trialist, and fundamental concepts in clinical pharmacology.
A practical guide to the design, conduction, analysis and reporting of clinical trials with anticancer drugs.
Section 1: Chapter 1: Basic Biostatistics for the Clinical Trialist Authors: Elizabeth G. Hill and Elizabeth Garrett-Mayer Chapter 2: Fundamental Concepts in Clinical Pharmacology Authors: Daniel L. Gustafson and Erica L. Bradshaw-Pierce Chapter 3: Bioanalytical Methods in Clinical Drug Development Authors: Walter J. Loos, Peter de Bruijn, Alex Sparreboom Section 2 Chapter 1: Preclinical Models for Anticancer Drug Development Author: Edward Sausville Section 3 Chapter 1: Phase I Clinical Trials with Anticancer Agents Authors: Stephen Leong, Justin Call, Alex Adjei, Wells Messersmith Chapter 2: Phase II Clinical Trials with Anticancer Agents Authors: Hui Gan, J. Jack Lee, Lillian L. Siu Chapter 3: Phase III Clinical Trials with Anticancer Agents Authors: Wendy Parulekar and Daniel J. Sargent Chapter 4: Pharmacokinetic Studies in Early Anticancer Drug Development Authors: Sharyn D Baker and Alex Sparreboom Chapter 5: Pharmacodynamic Studies in Early Phase Drug Development Authors: D. Ross Camidge, Robert C. Doebele and Antonio Jimeno Chapter 6: Prediction of Antitumor response Authors: Yu Shyr and Fred R. Hirsch Chapter 7: Imaging Studies in Anticancer Drug Development Author: David Mankoff Section 4 Chapter 1: Role of the US Food and Drug Administration in Cancer Drug Development Authors: Ann T. Farrell, Ramzi N. Dagher and Richard Pazdur Section 5 Chapter 1: Early Clinical Trials with Cytotoxic Agents Authors: M.J.A. de Jonge and Jaap Verweij Chapter 2: Challenges and Sucesses in Developing Effective Anti-Angiogenic Agents Authors: Laura QM Chow and S Gail Eckhardt Chapter 3: Targeted Therapeutics in Cancer Treatment Authors: Colin D. Weekes and Manuel Hidalgo Chapter 4: Cancer Chemoprevention Authors: Christopher H. Lieu, William N. William Jr., Scott M. Lippman Chapter 5: Combined Modality Therapy in Cancer Management Authors: David Raben and Kyle Rusthoven Chapter 6: Cancer Vaccines Author: Dan Laheru Chapter 7: Optimizing the Development of Antibodies as Treatment for Cancer Authors: Craig P Carden, Hendrik-Tobias Arkenau and JS de Bono Chapter 8: Oligonucleotide Therapeutics Authors: Cy A Stein, Britta Hoehn, John Rossi Chapter 9: Anticancer Drug Development in Pediatric Patients Authors: Lia Gore and Margaret Macy Chapter 10: Clinical Trials in Special Populations Authors: S. Percy Ivy, MD; Merrill J. Egorin, MD; Chris H. Takimoto, MD, PhD; and Jeannette Y. Wick, RPh Section 6: Chapter 1. NCI Sponsored Clinical Trials Author: Janet E. Dancey and Andriana Papaconstantinou