Phase I Cancer Clinical Trials: A Practical Guide
Author:   Elizabeth A. Eisenhauer (Head, Department of Oncology; Medical Director, Oncology Program, Queen's University, Kingston General Hospital, Cancer Centre of Southeastern Ontario) ,  Christopher Twelves (Professor of Clinical Pharmacology and Oncology; Head, Section of Clinical Cancer Research Groups, Leeds Institute of Molecular Medicine, St. James's Institute of Oncology) ,  Marc Buyse (Founder and Chairman; Associate Professor of Biostatistics, International Drug Development Institute; Universiteit Hasselt)
Publisher:   Oxford University Press Inc
Edition:   2nd Revised edition
ISBN:  

9780199359011


Pages:   368
Publication Date:   01 June 2014
Format:   Paperback
Availability:   To order   Availability explained
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Phase I Cancer Clinical Trials: A Practical Guide


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Author:   Elizabeth A. Eisenhauer (Head, Department of Oncology; Medical Director, Oncology Program, Queen's University, Kingston General Hospital, Cancer Centre of Southeastern Ontario) ,  Christopher Twelves (Professor of Clinical Pharmacology and Oncology; Head, Section of Clinical Cancer Research Groups, Leeds Institute of Molecular Medicine, St. James's Institute of Oncology) ,  Marc Buyse (Founder and Chairman; Associate Professor of Biostatistics, International Drug Development Institute; Universiteit Hasselt)
Publisher:   Oxford University Press Inc
Imprint:   Oxford University Press Inc
Edition:   2nd Revised edition
Dimensions:   Width: 15.60cm , Height: 1.70cm , Length: 23.40cm
Weight:   0.522kg
ISBN:  

9780199359011


ISBN 10:   0199359016
Pages:   368
Publication Date:   01 June 2014
Audience:   Professional and scholarly ,  Professional & Vocational
Format:   Paperback
Publisher's Status:   Active
Availability:   To order   Availability explained
Stock availability from the supplier is unknown. We will order it for you and ship this item to you once it is received by us.

Table of Contents

1. Introduction ; 2. Preclinical Data and Requirements ; 3. Phase 0 Clinical Trials ; 4. Basics of Phase I Design: First-in-man Studies ; 5. Ethical Issues in First-in-human Phase I Cancer Trials ; 6. Phase I Trials in Special Populations and Circumstances ; 7. Phase I Trials of Immunotherapeutics ; 8. Statistical Designs for First-in-human Phase I Trials ; 9. Writing the Protocol ; 10. Practical Aspects of Pharmacokinetics and Pharmacodynamics ; 11. Process, Pitfalls, and Logistics of Phase I Trials ; 12. Reporting and Interpreting Results ; Appendix: Useful Web Resources

Reviews

Phase I Cancer Clinical Trials: A Practical Guide, 2nd Edition is an indispensable guide for the specialized world of Phase I cancer studies. -- Journal of Clinical Research Best Practices


This is a well-written, well-structured book that comprehensively covers the unique aspects of phase I clinical trials in cancer patients. This may be the only book of its kind and will be appropriate for a wide audience. Karen L. Reckamp, MD, MS; Doodys Reviews


Author Information

EAE: Head, Department of Oncology, Queen's University, Medical Director, Oncology Program, Kingston General Hospital, Cancer Centre of Southeastern Ontario, Kingston, Canada; CT: Professor of Clinical Pharmacology and Oncology, Head, Section of Clinical Cancer Research Groups, Leeds Institute of Cancer Studies and Pathology, St. James's Institute of Oncology Leeds, UK; MB: Founder and Chairman, International Drug Development Institute, Louvain-la-Neuve, Belgium, Associate Professor of Biostatistics, Universiteit Hasselt Diepenbeek, Belgium

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