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Last Updated: 04/25/2012

Contributed by Dr. Sally Hunsberger

Dr. Sally Hunsberger has collaborated with Drs. Simon and Zhao on the development of an integrated phase 2/3 design for randomized clinical trials. The design uses a phase 2 intermediate endpoint for the interim analysis and a phase 3 endpoint for the final analysis. Randomized phase 2 designs require larger sample sizes than traditional single arm phase 2 designs, and an advantage of the seamless design is that data for the “phase 2 patients” can be used in the phase 3 evaluation if the trial is not stopped for futility at the interim analysis. This approach is attracting considerable attention and Dr. Zhao has developed a web-based planning tool for the design of integrated phase 2/3 designs. The tool is available on the BRB website

Dr. Hunsberger has collaborated with Drs. Rubinstein and Lorusso, analyzing phase I studies of biologic agents and has collaborated with Dr. Lucas Minig in evaluating the length of hospital stays for patients with gynecologic cancers. Dr. Hunsberger has been working with Dr. JoAnne Zujewski on the best way to evaluate new agents to treat metastatic triple negative breast cancer in the phase 2 setting.

Ballard-Barbash R, Hunsberger S, Alciati MH, et al. Physical activity, weight control, and breast cancer risk and survival: Clinical trial rationale and design considerations. J Nat Cancer Inst 2009:101;630-643.

Hunsberger S, Zhao YD, Simon R. A comparison of phase II study strategies. Clin Cancer Res 2009:15;5950-55.

Hunsberger S, Albert PS and London WB. A finite mixture survival model to characterize risk groups of neuroblastoma. Stat Med 2009:28;1301-1314.

Hunsberger S, Albert PS, Dodd L. Analysis of progression free survival data using a discrete time survival model that incorporates measurements with and without diagnostic error. Clin Trials 2010:7; 634-642.

McShane LM, Hunsberger S, Adjei AA. Effective incorporation of biomarkers into phase II trials. Clin Cancer Res 2009:15;1898-1905.

Smith M, Wheatley K, Devidas, M, Lock R, Hunsberger, S. Strategies for new agent development and clinical trial considerations. In: Childhood Leukemias. Reaman, GH, Smith FO, eds. New York, NY:Springer-Verlag;2011.

About the
Associate Director

Richard Simon Richard Simon, D.Sc., leads the Biometric Research Program and is chief of the Computational & Systems Biology Branch. Dr. Simon holds a doctoral degree in Applied Mathematics & Computer Science from Washington University in St. Louis, MO. More…

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