CLINICAL TRIALS- SHARED RESOURCES

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The Winship Cancer Institute's Clinical Trials Shared Resource, referred to as the Clinical Trials Office (WCI CTO), is part of the overall support for clinical trials research in the WCI and its activities are coordinated with the Protocol Review and Monitoring System (PRMS) and Data Safety Monitoring Plan (DSMP). The overall goal of the WCI CTO is to advance progress in cancer care through the support of highquality, high-impact clinical research by Cancer Institute members. In our organizational mode diseasefocused physician investigators work directly with research nurses, coordinators and regulatory specialists organized into nine disease or site-based management teams called Working Groups. The staff in the Working Group assist clinical investigators in enrolling subjects on therapeutic clinical research protocols and are responsible for high-quality data collection and submission. The Working Groups encompass all clinical investigators and clinical trial activities conducted at Emory University and its clinical affiliates. These activities are supported and coordinated by a central administrative core that provides oversight of clinical trial prioritization; budget and finances; staff training; development and implementation of policies and procedures for clinical trials activation, accrual, management, and operations; quality assurance and auditing functions; and regulatory affairs. The WCI CTO also provides support for designing investigator-initiated institutional trials in coordination with the Biostatistics Shared Core Resource. The WCI CTO works closely with the School of Medicine's clinical trials office as related to regulatory compliance and budgets and with the University's Office of Sponsored Programs for contracting issues. The WCI CTO supports therapeutic, prevention, ancillary, correlative, and non-interventional studies for investigators representing all four WCI scientific program areas. Under the direction of the Medical Director, Edmund Waller, MD, PhD, and the Associate Directors, Stephanie McMillan, RN, and Carol Hill, RN (Clinical Affairs), and Leah Holloway (Regulatory Affairs), the WCI CTO maintains a centralized database for both adult and pediatric trials and oversees all the services and functions of the CTO and its staff. In 2007, 442 unique cancer patients were accrued to therapeutic clinical trials representing 12% of the number of reportable cancer patients newly seen in that year. The number of patients enrolled on therapeutic clinical trails and has tripled over the past 6 years, with the fastest growth rates in the past 3 years seen in therapeutic institutional studies. Expanded access to clinical research and continued accrual of cancer patients onto therapeutic institutional studies are central to achieving the mission of the Winship Cancer Institute.