Oncology Clinical Trials (eBook)

Contents

Contributors

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

Preface

PART I. BACKGROUND AND INTRODUCTION TO ONCOLOGY CLINICAL TRIALS

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

PART II. DESIGNING ONCOLOGY CLINICAL TRIALS

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

PART III. CONDUCTING ONCOLOGY CLINICAL TRIALS

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

PART IV. ANALYZING RESULTS OF ONCOLOGY CLINICAL TRIALS

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

PART V. SPECIAL CONSIDERATIONS IN ONCOLOGY CLINICAL TRIALS

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

PART VI. COOPERATIVE GROUPS, REGULATORY AND GOVERNING BODIES

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

Index