The Stony Brook program provides a rich opportunity for resident involvement in clinical trials because of residency faculty involvement in leadership roles within such investigations. The Residency Program Director, Dr. Dorothy S. Lane, is also the Principal Investigator for the Stony Brook Women’s Health Initiative (WHI) Clinical Center, one of 40 participating in this landmark NIH clinical trial of preventive interventions for postmenopausal women. The Co-PI and Project Director for the Stony Brook WHI is the Residency Program Associate Director, Dr. Iris A. Granek. She is a completer of our residency program, participated in the writing of the contract as a resident, and now has the major responsibility for its implementation and current operation. Dr. Granek supervises residents spending time within the clinical center and residents can participate in all aspects of visit examination and data collection, dealing with adherence and retention, gaining experience in promoting long-term dietary changes through the group intervention, and preparing for quality assurance visits. The residents also have the opportunity to analyze our center’s data on close to 4,000 elderly women. Residents can also assist with the annual IRB review. The magnitude and quality of this nationwide study enables WHI to serve as an excellent model for learning clinical trial methodology. WHI ancillary studies in the hormone clinical trials (HT) include the Women's Health Initiative Memory Study, the Women's Health Initiative Study of Cognitive Aging, and the Women's Health Initiative Sight Exam Study. “Fat Reduction, HRT Use, Calcium and Vitamin D Use, and Benign Breast Disease Risk” is another ancillary study of the WHI clinical trials that is studying the effect of the interventions on the risk of benign breast disease. The residents can work on all aspects of these ancillary studies.

Dr. Granek is PI for the NCI-supported Stony Brook SELECT study and provides resident supervision at the SELECT Center. Dr. Lane is Co-PI for the study and integrates this experience with other training. Stony Brook is one of the over 400 sites participating in this twelve-year prostate cancer prevention clinical trial coordinated by the Southwest Oncology Group. Participant recruitment began in 2001, the interventions are selenium and vitamin E, and the primary outcome is prostate cancer and secondary outcomes include other cancers. The residents can be involved in all aspects of this trial which provides them with experience in research coordinated through one of the largest cancer trial cooperative groups and which makes effective use of web based technology.

Other clinical trials within the Department available for resident participation are testing health education interventions. The Early Detection Guidelines Education (EDGE) 2 project funded by the NCI is testing the effectiveness of tailored telephone counseling, either with or without physician continuing education, on regular use of colorectal cancer screening, compared to no intervention. The PI for this project, Dr. Lane, involves interested residents in various aspects of the trial. A related NCI-supported grant, titled “Colorectal Cancer Screening in Community Health Centers,” focuses on shared decision-making among minority/disadvantaged community health center patients and provides additional resident opportunities.

The Department of Preventive Medicine also has considerable experience in NIH-supported epidemiologic research in eye disease. This includes serving as the data center for an international clinical trial of early treatment of glaucoma. The department’s funded eye research projects have recently expanded to include genetic studies that have already resulted in publications relating to the inheritance of open-angle glaucoma. The Barbados National Cancer Study is a comprehensive study of environmental and genetic risk factors for prostate and breast cancer. Linkage analyses will be performed to identify genes potentially associated with prostate and breast cancer and a full genome-wide scan will be conducted for each cancer. This research is of particular interest, because 93% of the Barbados population is black with origins primarily from regions in West Africa.