The American College of Surgeons Oncology Group (ACOSOG or Group) was established in 1998 with the mission to conduct clinical studies that were designed primarily to evaluate the surgical management of patients with malignant solid tumors. Initially, the Group was funded for two years and charged to develop an administrative and statistical infrastructure to support the performance of clinical trials. During this period ACOSOG was located in Chicago at the headquarters of the American College of Surgeons (ACoS). The Group was structured with an Administrative Coordinating Center (ACC) and a Statistics and Data Coordinating Center (SDCC). Dr. Samuel A. Wells was the Group Chair and Dr. Brent Blumenstein was the Group Statistician. Additional personnel were recruited to manage operations such as: grants administration, information services and technology, communications and publications, membership, study development, data management, quality assurance and regulatory affairs, education and auditing. A second site visit was held in the fall of 1999 and the Group was funded for five additional years. ? ? Shortly after the competitive renewal in 2000 it became apparent to the Executive Committee of ACOSOG and to the Board of Regents of the ACoS that ACOSOG would benefit by being closer to an academic environment, which could provide the resources and personnel necessary to operate a robust clinical research program. The ACOSOG formed a search committee, which visited several academic centers, including: the Pritzker School of Medicine at the University of Chicago, the Feinberg School of Medicine at Northwestern University, the Stritch School of Medicine at Loyola University, the Washington University School of Medicine, the University of Wisconsin School of Medicine and the Duke University School of Medicine (DUSM). The Search Committee unanimously recommended that ACOSOG move to Duke and this relocation took place in January 2001. ? ? The decision to move to Duke was influenced by the presence of three important academic units: ? ? a. The Duke Clinical Research Institute (DCRI), an 800-member academic research organization based within the DUSM, which is primarily concerned with the conduct of clinical trials (mostly supported by the private sector) in a broad range of disciplines, excepting oncology. ? ? b. The National Cancer Institute (NCI) funded Duke Comprehensive Cancer Center (DCCC). ? ? c. The Statistical Center for the Cancer and Leukemia Group B (CALGB). ? ? Only four of the administrative staff relocated to Duke, including: the Group Chair, the Group Statistician, the Data Manager and the Program Director. Following the move, over 50 additional staff members were recruited, including a Group Administrator, a Director of Operations, an Audit Manager, a Director of Information Technology, a Safety Surveillance Coordinator and a vice-chair of Study Development. ? ? The ACOSOG Executive Committee felt that the move to the DUSM was essential to the viability of the Group, but recognized that the move would be difficult, primarily for two reasons: ? ? a. The ACOSOG needed to recruit a large support staff, almost all of who would be unfamiliar with the policies and procedures of the NCI-funded Cooperative Group program supported by the Cancer Therapy Evaluation Program (CTEP) of the NCI. This steep learning curve for recruited personnel would be complicated by the ongoing necessity to manage the essential affairs and operations of the Group, including protocol development, data management (including quality assurance), membership recruitment and education. ? ? b. Early in the course of ACOSOG studies it became evident that most of the participating surgeons were not experienced in the theory and practice of cooperative group clinical trials. It was necessary to develop broad based educational programs for the surgeons, clinical research associates (CRAs), nurses and data managers at participating sites, to assure that they possessed the requisite knowledge and skills to function in an efficient and responsible manner. ? ? In 2003 the Group Statistician (Dr. Brent Blumenstein) and the Data Manager (Ms. Ma. Theresa Rallonza) left ACOSOG to pursue other interests. Dr. James Herndon, a statistician with CALGB, was recruited to replace Dr. Blumenstein and Ms. Shirley Ellis, a Clinical Data Specialist within ACOSOG, was recruited to replace Ms. Rallonza. ? ? In November 2003 Dr. Richard Kaplan of CTEP informed the ACOSOG administration that the grants, which supported the ACC and the SDCC, would be reduced by fifty percent. The funding cycle of the grants would be changed to a December start date. The last year of the grant was truncated by five months. The reduction was effective May 2004. The reasons given for this action were: a) the lack of a suitable number of Phase III trials; b) the lower than expected accrual to active clinical trials; and c) perceived insufficient support from the ACoS. ? ? After a thorough review of the Group's intramural and extramural operations and personnel the ACOSOG ACC and SDCC presented a restructuring plan and budget to the Executive Committee at the ACOSOG semiannual meeting in January 2004. The primary components of the plan called for significant reduction in the ACOSOG staff and a prioritization of the number of clinical studies that would be developed by the Group. The positions of fourteen staff members, including: the Director of Medical Affairs, a Medical Officer, the Audit Manager, the Regulatory Affairs Consultant, the Protocol Development Manager and a Ph.D. Statistician, were eliminated. Realizing that additional funds would be necessary for the Group to function adequately, Dr. Wells, the Group Chair, met with the Board of Regents of the ACoS and requested additional support for the Group's effort. The Regents agreed to provide the requested amount ($576,000) to support ACOSOG operations until the time of the Site Visit for the competitive renewal in October 2004. The support from the ACoS was essential to the Group's continued function. ? ?
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