Controversies Related to Oncology Clinical Trial Development

Elihu H. Estey,

Elihu H. Estey

University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA

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Elihu H. Estey,

Elihu H. Estey

University of Washington and Fred Hutchinson Cancer Research Center, Seattle, WA, USA

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Book Editor(s):Syed A. Abutalib MD,

Syed A. Abutalib MD

Assistant Director

Hematology and Hematopoietic Cell Transplantation, Midwestern Regional Medical Center; Cancer Treatment Centers of America, Zion, IL, USA

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Maurie Markman MD,

Maurie Markman MD

Senior Vice President of Clinical Affairs

National Director of Medical Oncology, Cancer Treatment Centers of America; Clinical Professor of Medicine, Drexel University College of Medicine, Philadelphia, PA, USA

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First published: 20 June 2014

https://doi.org/10.1002/9781118589199.ch130

Summary

This chapter presents a series of questions and answers on controversies related to oncology clinical trial development. It commences with a discourse on a 3 + 3 design to determine dose for phase II, and ends with the advantages of designs that simultaneously monitor more than one outcome. The chapter also discusses on the Simon phase II design, and the standard phase III design.

References

Cancer Consult: Expertise for Clinical Practice