Oncology Clinical Trials

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Oncology Clinical Trials

SKU# 9780826168726

Successful Design, Conduct, and Analysis

William Kevin Kelly DO
Susan Halabi PhD

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    The second edition of Oncology Clinical Trials has been thoroughly revised and updated and now contains the latest designs and methods of conducting and analyzing cancer clinical trials in the era of precision medicine with biologic agents—including trials investigating the safety and efficacy of targeted therapies, immunotherapies, and combination therapies as well as novel radiation therapy modalities. Now divided into six sections this revamped book provides the necessary background and expert guidance from the principles governing oncology clinical trials to the innovative statistical design methods permeating the field; from conducting trials in a safe and effective manner, analyzing and interpreting the data, to a forward-looking assessment and discussion of regulatory issues impacting domestic, international, and global clinical trials.

    Considered by many as the gold standard reference on oncology clinical trials in the field, the second edition continues to provide examples of real-life flaws and real-world examples for how to successfully design, conduct and analyze quality clinical trials and interpret them. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, this volume provides a comprehensive guide in the design, conduct, monitoring, analysis, and reporting of clinical trials in oncology.


    • Outlines how to design clinical trials with and without biomarker testing—including genomics-based “basket” trials, and adaptive trials for all phases during treatment and quality-of-life trials
    • Includes new chapters on immunotherapy trials, radiation therapy trials, multi-arm trials, meta-analysis and adaptive design, use of genomics, dose modifications and use of ancillary treatments in investigational studies, establishing surrogate endpoints, practical issues with correlative studies, cost-effectiveness analysis, and more
    • Comprehensively covers all regulatory aspects in the pursuit of global oncology trials
    • Digital access to the ebook included

    Product Details

    • Publication Date March 28, 2018
    • Page Count 600
    • Product Form Hardback
    • ISBN 13 9780826168726
    • EISBN

    Table of Contents



    Foreword Clifford A. Hudis, MD and Richard L. Schilsky, MD



    1. The Changing Landscape of Clinical Research and Trials

    Susan Halabi and William Kevin Kelly

    2. Historical Perspectives of Oncology Clinical Trials

    Ada H. Braun and David M. Reese

    3. Ethical Principles Guiding Clinical Research

    Jackson Bruce Smith

    4. Industry Collaboration When Developing Novel Agents in Oncology

    Hong Xie

    5. The Trials and Tribulations of Writing and Conducting an Investigator Initiated Trial

    Jake Vinson, Josh Buddle, Julie Filipenko, Christine Tran, Kristofer Prepelica, and Sarah Wise

    6. Writing a Consent Form

    Christine Grady

    7. Why Do Clinical Trials Fail?

    Laurence Collette, Jan Bogaerts, and Xavier Paoletti


    8. Choice of Endpoints in Cancer Clinical Trials

    Mei-Yin Polley, Wenting Wu, and Daniel J. Sargent

    9. Design, Testing, and Estimation in Clinical Trials

    Barry Kurt Moser

    10. Innovative Phase I Clinical Trials

    Nolan A. Wages

    11. Pharmacokinetics in Clinical Oncology

    Jill M. Kolesar

    12. Dose Finding Using the Continual Reassessment Method

    Mark R. Conaway

    13. Design of Phase II Trials

    Hongkun Wang and Gina R. Petroni

    14. Biomarkers in Confirmatory Clinical Trials

    Thomas Gwise

    15. Bayesian Designs in Clinical Trials

    Gary L. Rosner, B. Nebiyou Bekele, and Yuan Ji

    16. Selection Designs

    Suzanne E. Dahlberg

    17. Phase III Oncology Clinical Trials

    Antje Hoering and John Crowley

    18. Design of Noninferiority Trials in Oncology

    Lei Nie and Zhiwei Zhang

    19. Design of Quality of Life Studies

    Amylou C. Dueck and Katie L. Kunze

    20. Adaptive Designs

    Tze L. Lai, Ying Lu, and Ka Wai Tsang


    21. Randomization

    Susan Groshen

    22. Case Report Form Development

    Susan Barry

    23. Monitoring, Assessing, and Reporting Adverse Events

    Amy Callahan, Elizabeth Ness, and Helen Chen

    24. Dose Modification and Use of Ancillary Treatments in Investigational Studies in Clinical Trials

    Yoshihito David Saito, Pamela Harris, Ming Poi, and Robert Wesolowski

    25. Assessment of Patient-Reported Outcomes in Industry-Sponsored Clinical Trials

    Ari Gnanasakthy and Ethan Basch

    26. Recruitment of Research Participants

    Christopher Gantz

    27. Barriers to Oncology Clinical Trials

    Chethan Ramamurthy and Yu-Ning Wong

    28. The Role of Novel Imaging Techniques in Clinical Trials

    Binsheng Zhao and Lawrence H. Schwartz

    29. Practical Issues With Correlative Studies

    David McConkey and Woonyoung Choi

    30. The Development of Companion Diagnostics in Oncology Clinical Trials

    Zixuan Wang and Stephen C. Peiper


    31. Interim Analysis and Data Monitoring

    Scott R. Evans and William T. Barry

    32. Reporting of Results: Data Analysis and Interpretation

    Donna Niedzwiecki

    33. Statistical Considerations for Developing and Validating Prognostic Models of Clinical Outcomes

    Susan Halabi and Lira Pi

    34. Statistical Evaluation of Surrogate Endpoints in Cancer Clinical Trials

    Marc Buyse, Geert Molenberghs, Xavier Paoletti, Koji Oba, Ariel Alonso, Wim Van der Elst, and Tomasz Burzykowski

    35. Development and Validation of Genomic Signatures

    Stefan Michiels, Nils Ternès, and Federico Rotolo

    36. Competing Risks Analysis in Clinical Trials

    Solange Bassale, Jeong Youn Lim, and Motomi Mori

    37. Systematic Reviews and Meta-Analysis

    Claire Vale, Sarah Burdett, David Fisher, Larysa Rydzewska, and Jayne Tierney

    38. Statistical Methods for Genomics-Driven Clinical Studies

    Richard Simon

    39. Handling Missing Data in Oncology Clinical Trials

    Xiaoyun (Nicole) Li, Cong Chen, and Xiaoyin (Frank) Fan


    40. Health-Related Quality of Life Studies in International Randomized Controlled Oncology Clinical Trials

    Andrew Bottomley, Corneel Coens, Murielle Mauer, Madeline Pe, and Francesca Martinelli

    41. The Economics of Oncology Clinical Trials

    Michaela A. Dinan and Shelby D. Reed

    42. Special Considerations in Immunotherapy Trials

    Claire F. Friedman, Katherine S. Panageas, and Jedd D. Wolchok

    43. Special Considerations in Radiation Therapy Trials

    Amanda J. Walker, Hyun Kim, Paul G. Kluetz, Julia A. Beaver, Gideon Blumenthal, and Richard Pazdur

    44. Clinical Trials in Hematologic Malignancies

    Neil Palmisiano, Bradley M. Haverkos, Sameh Gaballa, Joanne Filicko-O’Hara, Pierluigi Porcu, and Margaret Kasner

    45. Issues in Recruiting Elderly, Underserved, Minority, and Rural Populations (and Solutions)

    Cecilia R. DeGraffinreid, Jill Oliveri, Chasity Washington, Cathy Tatum, and Electra D. Paskett

    46. Telemedicine and Clinical Trials

    Ana Maria Lopez


    47. Cooperative Groups and Global Clinical Trials in the Future

    Cooperative Groups: An American and Canadian Perspective

    Joseph A. Sparano, Judith Manola, and Robert L. Comis

    Cooperative Groups: A Japanese Perspective

    Kenichi Nakamura, Haruhiko Fukuda, and Yasuo Ohashi

    Cooperative Groups: The Australian Perspective

    Prudence A. Francis, Katrin Sjoquist, and Linda Mileshkin

    Cooperative Groups: A Latin American Perspective

    Gustavo Werutsky

    48. The Evolution of the Drug Evaluation Process in Oncology: Regulatory Perspective

    The Evolution of Oncology Drug Evaluation at the FDA

    Steven J. Lemery, Gideon Blumenthal, Paul G. Kluetz, Patricia Keegan, Amy McKee, and Richard Pazdur

    The Evolution of the Drug Evaluation Process in the EU

    Francesco Pignatti, Emmanuelle Kempf, and Pierre Demolis

    The Evolution of the Drug Evaluation Process in Japan

    Hiroyuki Sato, Tomohiro Yamaguchi, Yuki Ando, and Takahiro Nonaka

    49. Clinical Trials in the Year 2025

    Apostolia M. Tsimberidou, Peter Müller, and Richard L. Schilsky