Affiliate Professor, Biostatistics
Fred Hutchinson Cancer Research Center
Methods For Multicenter Studies Of Women's Health.
The objective of the Women's Health Initiative is to study the prevention of and risk factors for the major causes of morbidity and mortality in post-menopausal women. This project presents a challenging combination of study design, monitoring and analysis issues. The clinical trial component is a partial factorial design with three interventions: Hormone Replacement Therapy; Dietary Modification; and Calcium and Vitamin D supplements. Approximately 67,000 women from 40 clinical centers around the country will be participating in the clinical trial. Multiple disease endpoints are ascertained with particular emphasis on breast and colorectal cancer, coronary heart disease, and osteoporotic fractures. An additional 100,000 women will be enrolled and followed in a parallel observational study. Data from these women provide a rich resource for conducting case-control studies of many diseases.
The coordinating center for WHI works to identify and address both scientific and operational issues. As a statistician and Co-PI of the WHI Coordinating Center, I am interested in bringing the best principles of experimental design and methods to the conduct of this study. There are a wide array of statistical design and analysis issues that arise including measurement error problems, subsampling designs, missing data, and trial monitoring for early stopping with multiple endpoints. Decisions regarding experimental design must be informed by operational and cost constraints. My day-to-day tasks often involve trying to balance the desire for the highest scientific integrity with the realities of operational constraints.
Analysis of study data is the most rewarding aspect of coordinating center work. In WHI, most analyses are multidisciplinary collaborative efforts with study investigators from the coordinating center and other sites. Coordinating center scientists play a key role in developing and testing hypotheses, in determining the strength of the WHI database to address questions of interest, and in interpreting the results.
I have recently begun to pursue my interest in ovarian cancer in collaboration with Nicole Urban and others through the Marsh Rivkin Center for Ovarian Cancer. My efforts are directed at developing methods for early detection using on serum biomarkers.
PhD Mathematical Sciences, University of Washington, 1989
MA Mathematical Sciences, State Univ of New York (Binghamton), 1983
BS Mathematics, Northwest Nazarene College , 1981