Randomized Clinical Trials - Whole Genome Studies Coordinating Center

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DESCRIPTION (provided by applicant): The Department of Biostatistics at the University of Washington proposes to establish a Coordinating Center for a series of genome-wide association studies of treatment response in randomized clinical trials. The Coordinating Center will be administered within the Center for Biomedical Statistics of the Department of Biostatistics and it will take advantage of the experience gained by departmental activities as Coordinating Center for the Geneva project. Geneva is a series of 14 genome-wide association studies within the Gene-Environment Initiative. The new RTC-WGA Coordinating Center will be co-directed by Bruce Weir, Chair of the Department of Biostatistics and PI of the Geneva Coordinating Center, and by Patrick Heagerty, Director of the Center for Biomedical Statistics. They will be joined by Biostatistics faculty Scott Emerson, Ken Rice, Lianne Sheppard, Jon Wakefield, Epidemiology faculty member Annette Fitzpatrick and by Medicine faculty member Bruce Psaty. These faculty have substantial experience in the conduct of both clinical trials and genetic studies, as well as in studying the effects of environmental exposures. They will be able to seek advice from a distinguished advisory panel of Lon Cardon, Tom Fleming, Dick Kronmal and Ross Prentice. The Coordinating Center will provide administration and coordination of all activities for the set of whole-genome analyses of data from participants in clinical trials at study sites. The Center will facilitate harmonization and sharing of phenotypic and genetic data across study sites, the genotyping centers and dbGaP. The Center will assure the integrity of data by implementing appropriate data management procedures and quality control activities. The Coordinating Center will provide statistical support for modeling and selecting options for replication and follow-up studies, and, as appropriate, for selecting targets for sequencing and functional studies as well as analytic support for issues inherent to randomized clinical trials. The Coordinating Center will serve as a resource to facilitate and support all NHGRI whole-genome association studies, including the training of researchers in appropriate statistical methodology and the provision of computer software for statistical analyses. Public Health Relevance: People may respond to treatments for disease in a way that depends on their genetic constitution. There would be many benefits if the possibility that they will have adverse reactions could be predicted on the basis of a simple blood test. The best way to determine the relationship between genetic constitution and response to treatment is with a randomized clinical trial. The coordinating center will manage the data from these trials.