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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 29, 2018
  • Page Count 600
  • Product Form Hardback
  • ISBN 13 9780826168726
  • EISBN 9780826168733

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