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 TrialistAuthors: Elizabeth G. Hill and Elizabeth Garrett-MayerChapter 2: Fundamental Concepts in Clinical PharmacologyAuthors: Daniel L. Gustafson and Erica L. Bradshaw-PierceChapter 3: Bioanalytical Methods in Clinical Drug DevelopmentAuthors: Walter J. Loos, Peter de Bruijn, Alex SparreboomSection 2Chapter 1: Preclinical Models for Anticancer Drug DevelopmentAuthor: Edward SausvilleSection 3Chapter 1: Phase I Clinical Trials with Anticancer AgentsAuthors: Stephen Leong, Justin Call, Alex Adjei, Wells MessersmithChapter 2: Phase II Clinical Trials with Anticancer AgentsAuthors: Hui Gan, J. Jack Lee, Lillian L. SiuChapter 3: Phase III Clinical Trials with Anticancer AgentsAuthors: Wendy Parulekar and Daniel J. SargentChapter 4: Pharmacokinetic Studies in Early Anticancer Drug DevelopmentAuthors: Sharyn D Baker and Alex SparreboomChapter 5: Pharmacodynamic Studies in Early Phase Drug DevelopmentAuthors: D. Ross Camidge, Robert C. Doebele and Antonio JimenoChapter 6: Prediction of Antitumor responseAuthors: Yu Shyr and Fred R. HirschChapter 7: Imaging Studies in Anticancer Drug DevelopmentAuthor: David MankoffSection 4Chapter 1: Role of the US Food and Drug Administration in Cancer Drug DevelopmentAuthors: Ann T. Farrell, Ramzi N. Dagher and Richard PazdurSection 5Chapter 1: Early Clinical Trials with Cytotoxic AgentsAuthors: M.J.A. de Jonge and Jaap VerweijChapter 2: Challenges and Sucesses in Developing Effective Anti-Angiogenic AgentsAuthors: Laura QM Chow and S Gail EckhardtChapter 3: Targeted Therapeutics in Cancer TreatmentAuthors: Colin D. Weekes and Manuel HidalgoChapter 4: Cancer Chemoprevention Authors: Christopher H. Lieu, William N. William Jr., Scott M. LippmanChapter 5: Combined Modality Therapy in Cancer ManagementAuthors: David Raben and Kyle RusthovenChapter 6: Cancer VaccinesAuthor: Dan LaheruChapter 7: Optimizing the Development of Antibodies as Treatment for CancerAuthors: Craig P Carden, Hendrik-Tobias Arkenau and JS de BonoChapter 8: Oligonucleotide TherapeuticsAuthors: Cy A Stein, Britta Hoehn, John RossiChapter 9: Anticancer Drug Development in Pediatric PatientsAuthors: Lia Gore and Margaret MacyChapter 10: Clinical Trials in Special PopulationsAuthors: S. Percy Ivy, MD; Merrill J. Egorin, MD; Chris H. Takimoto, MD, PhD; and Jeannette Y. Wick, RPhSection 6:Chapter 1. NCI Sponsored Clinical TrialsAuthor: Janet E. Dancey and Andriana Papaconstantinou