edited by Elizabeth A. Eisenhauer, Christopher Twelves, Marc Buyse
Second edition
xi, 356 pages :
illustrations ;
24 cm
Preceded by Phase I cancer clinical trials : a practical guide / Elizabeth A. Eisenhauer, Christopher Twelves, Marc Buyse. 1st ed. 2006
Includes bibliographical references and index
1. Introduction / Elizabeth A. Eisenhauer -- 2. Preclinical data and requirements / Sophie Postel-Vinay, Jean-Charles Soria, Elizabeth A. Eisenhauer -- 3. Phase 0 clinical trials / Shivaani Kummar and James H. Doroshow -- 4. Basics of phase I design : first-in-man studies / Donna M. Graham, Aaron R. Hansen, Elizabeth A. Eisenhauer, and Lillian l. Siu -- 5. Ethical issues in first-in-human phase I cancer trials / Elizabeth A. Eisenhauer -- 6. Phase I trials in special populations and circumstances / Rajiv Kumar, Christopher Twelves, and Udai Banerji -- 7. Phase I trials of immunotherapeutics / Christy Ralph, Emma King, Christopher Twelves, and Christian Ottensmeier -- 8. Statistical designs for first-in-human phase I trials / Xavier Paoletti and Marc Buyse -- 9. Writing the protocol : Penelope A. Bradbury and Elizabeth A. Eisenhauer -- 10. Practical aspects of pharmacokinetics and pharmacodynamics / Christopher Twelves, Maria Jove, and Paul Loadman -- 11. Process, pitfalls, and logistics of phase I trials / Elizabeth A. Eisenhauer, Hayley Isenhauer, and Lesley K. Seymour -- 12. Reporting and interpretating results / Lesleigh S. Abbott, Elizabeth A. Eisenhauer, and Lesley K. Seymour