Principles of Anticancer Drug Development

A practical guide to the design, conduction, analysis and reporting of clinical trials with anticancer drugs.

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.

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 ChemopreventionAuthors: 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