Oncology Clinical Trials (eBook, ePUB)

Successful Design, Conduct, and Analysis
Redaktion: Kelly, William Kevin; Halabi, Susan

• Format: ePub

Produktbeschreibung

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.

NEW TO THIS EDITION:

• 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

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Produktdetails

• Verlag: Springer Publishing Company
• Seitenzahl: 600
• Erscheinungstermin: 28. März 2018
• Englisch
• ISBN-13: 9780826168733
• Artikelnr.: 52062698

Inhaltsangabe

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 Con
rmatory 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 Modi
cation 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. DeGraf
nreid, 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