CANCER AND LEUKEMIA GROUP B

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This application represents the first competitive renewal of the CALGB institutional grant submission from the University of North Carolina at Chapel Hill (UNC-CH) and its affiliates. UNC-CH has been a member of CALGB since 1986 and currently ranks at least in the top third of Group institutions as judged by any yardstick, but only received NCI institutional support through out-of-cycle review and Type 5 redistribution this past year. Previous reviews have praised the excellent science and leadership represented by the UNC-CH membership as well as our data management and quality assurance. We have continued our rapid accrual expansion to nearly 200 cases in 1991. Moreover, our institution now has broad leadership participation in the Group in virtually every committee and is the research base for a Minority CCOP. We have increased accrual to Phase I, II, III and companion studies to a level that is well above the average of other outstanding institutions in the Group. Secondly, we have added major affiliates that have achieved 50% of our 1991 accrual while maintaining excellent data quality control and have established rigorous internal audit and quality assurance procedures. In 1992, we will add several new affiliates with the future capacity to accrue between 50-100 additional cases (including a high proportion of minority cases) to our current baseline of 200. Third, our leadership efforts in the Group have also continued to expand. We now enjoy the distinction of having two committee chairs, three committee vice-chairs, sixteen committee core members, two Executive Committee members, more than 20 protocol principal investigators or co- investigators and three members of the Board of Directors. In addition, the efforts of UNC-CH through CALGB were instrumental in leading to the Minority CCOP award to Chris Desch of our affiliate, MCV and funding of his Minority CCOP Program in Southern Virginia, which uses UNC-CH as its research base. Our overall minority accrual to all CALGB studies remains at five times the national average at 25% and our accrual of women is 58% compared to the Group average of 53%. We plan to continue direct service to the Group by first of all maintaining an active reference laboratory in molecular epidemiology involving leukemia, myelodysplasia, breast and colorectal studies. We have further broadened Group science by the addition of companion studies in myelodysplasia, AML and breast cancer designed by Edison Liu, Dale Sandler, Robert Sandler and Paul Godley, some with independent funding. Previous and new members of our institution have continued to expand our contribution to Group scientific and administrative committees and studies (H. Ozer, Executive Committee, Leukemia Core, Lymphoma core, PET Core, Biotherapy vice-Chair, Industrial Relations Core; K. Rao, Cytogenetics Core; J. Tepper, Radiation Oncology Core, Executive Committee, GI Vice-Chair; Gavigan, Data Audit Core, Oncology Nursing Chair; D. Sandler, Epidemiology Chair, Correlative Science Core; E. Liu, Correlative Science core; T. Shea, Transplant core; J. Rosenman, Radiation Oncology core; R. Sandler, Epidemiology; P. Godley, Minority Consortia). Additional faculty at UNC-CH will expand our commitment and Group leadership in the Breast and Surgery committees (J. Huth, W. Cance, M. Graham, J. Mohler); Radiation Therapy (S. Sailer), Epidemiology (P. Godley), Cancer Prevention and Control Sciences (R. Sandler) and GU (P. Godley). We therefore believe that this application reflects the growing and crucial contribution that UNC-CH investigators provide to the Group in leadership, science and service and confirms our energetic efforts to increase accrual through the addition of major affiliates with rigorous control of quality data submission.