Department of Biostatistics Seminar/Workshop Series

Applications of Statistics to Medicine: Drug Synergy, Clinical Trials and Biomarker Evaluation

Ming T. Tan, PhD

Professor and Head, Division of Biostatistics and Bioinformatics, Department of Epidemiology and Public Health & University of Maryland Greenebaum Cancer Center, University of Maryland School of Medicine

Thursday, May 5, 11:00am-12:00pm, 898-J PRB

This presentation covers statistical issues in the design and analysis of translational, clinical and epidemiological studies. I will first present statistical approaches for evaluating drug interactions and utilization of the preclinical data to guide early phase clinical trial design. The implications of the approach in developing SAHA and cytotoxic drug combinations will be discussed. Then I will discuss stochastic curtailing approaches and the adaptive sequential approach for the design and interim analysis of clinical trials. The issue is how to evaluate emerging evidence for efficacy or the lack of it thereof. The approach is built on the concept of discordance probability, defined as the probability that the decision to reject or accept the null hypothesis based on interim data would be reversed should the trial continue to its planned end and be analyzed with a non-sequential test. I will discuss the implications of using the method in several cardiovascular and cancer clinical trials and some unresolved problems. Finally, I will present work on high dimensional biomarker evaluation where procedures that favors predictive power are important in reducing over-fitting.
Topic revision: r2 - 26 Apr 2013, JohnBock

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