NCI National Clinical Trials Network – Network Lead Academic Participating Site

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Wayne State University (WSU)/ Karmanos Cancer Institute (KCI) has been an active institutional member of the cooperative group system since 1972, an NCI designated Comprehensive Cancer Center since 1978, and a parent institution Phase I (U01) since 1993. We have an active membership in the NCTN and have been an active LAPS since its inception in 2013 enrolling patients in network trials through the CTSU and using the CIRB for activation. We have enrolled over 5,500 patients onto NCTN clinical trials over the past forty years and over 250 patients have been enrolled onto interventional trials since 2014, meeting and exceeding accrual goals in a consistent manner. Since April 2014, we have opened 52 NCTN trials, including 8 Alliance, 13 ECOG-ACRIN, 17 NRG and 14 SWOG. All adult NCTN qualifying Phase II and III protocols have been submitted through the CIRB for activation since 2009. Over the years, our faculty members have played an important role in both the administrative and scientific functions of the NCTN. Since 2014, eight faculty members have held nineteen leadership positions in SWOG and ECOG-ACRIN as well as serving on NCI organ site Task Forces and Steering Committees. Since 2014, 13 faculty members have been authors or co-authors of 41 NCTN abstracts or manuscripts, and 7 faculty members have been PI or Co-PIs of 11 NCTN clinical trials. Our Cancer Center is a unique urban based center of research, patient care and education which is reflected in our recruitment of minorities (24%) and women (44%) onto intervention trials. Since our inception, the cancer programs of WSU/KCI have been organized as multidisciplinary disease programs built on the premise that multidisciplinary clinical research and care provides the best treatment option for patients with cancer. Accordingly, the translation of ideas into Network Group proposals and studies and the incorporation of NCI designated high-priority trials into the WSU/KCI treatment priorities have been easily facilitated. NCI funded trials have the highest priority for activation within our institution. Dr. Lawrence Flaherty, a SWOG member since 1988, the SWOG U-10 PI since 1996 and LAPS PI since 2013 will serve as the PI of this submission. He was the SWOG Melanoma Vice Chair from 1990 until 2011 and has been Chair of the SWOG Data Safety and Monitoring Committee since 2011. Anthony Shields, M.D., PhD. is the Project Director/Principal Investigator of the WSU/KCI LAPS serves on the NCI Colon Cancer Task Force, the ECOG-ACRIN Principal Investigator Committee, the Scientific Planning Committee, and the Nomination Committee. He is the co-chair of the Experimental Imaging Sciences Committee and the Biomarker Steering Committee.