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Phase II Clinical Trial Design: Methods in Translational Research from the Genitourinary Committee at the Eastern Cooperative Oncology Group

Authors' Affiliations: ¹ Eastern Cooperative Oncology Group, Harvard School of Public Health; ² Dana-Farber Cancer Institute; ³ Beth Israel Deaconess Medical Center, Boston, Massachusetts; ⁴ National Cancer Institute, Cancer Therapy Evaluation Program, Bethesda Maryland; ⁵ Our Lady of Mercy, Bronx, New York; ⁶ Johns Hopkins University, Baltimore, Maryland; ⁷ The University of Medicine and Dentistry of New Jersey, The Cancer Institute of New Jersey, New Brunswick, New Jersey; ⁸ Medical College of Wisconsin, Milwaukee, Wisconsin; ⁹ Indiana University, Bloomington, Indiana; ¹⁰ The University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin; and ¹¹ Cleveland Clinic Foundation, Cleveland, Ohio

Requests for reprints: Robert S. DiPaola, Cancer Institute of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08901. Phone: 732-235-7469; E-mail: dipaolrs{at}umdnj.edu.

Given the increase in novel agents and difficulty with planning and completing many phase III studies, various phase II trial design options should be considered to more effectively guide phase III trial plans. The need for novel phase II trial designs has increased, given the number of novel molecular targeted therapies now available for testing, an abundance of cytostatic agents, and limited resources to conduct phase III studies for all interesting agents or combinations. This review will focus on options for phase II trial designs. We review randomized phase II designs with placebo control, randomized selection designs, and randomized discontinuation designs. As agents become available for testing in the clinic, the strengths and weaknesses of different phase II trial designs should be considered to optimize a trial development plan that guides phase III trial decisions more effectively.

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