Duke Medical Center is currently completing its second five year grant cycle as a member of Cancer and Leukemia Group B (CALGB). Throughout Duke's involvement with CALGB, this institution has consistently been one of the top institutions in overall patient accrual and specifically has been one of the leading institutions in patient accrual from a main member institution. Over the period of the last grant cycle, Duke has developed an affiliate program through the Duke Oncology Consortia (DOC) which involves cancer centers and hospitals throughout the Southeast United States. This affiliate membership is still growing in number of sites and level of participation in clinical trials. In addition, the Duke Oncology OutReach Services (DOORS) network provides onsite cancer care at small hospitals and clinics in neighboring counties. Both intramural and extramural clinical trial participation are coordinated through centralized clinical trials offices at Duke. This includes personnel support for core administrative functions, clinical trial coordination provided by disease and modality specific clinical research nurses, and data management and follow-up by dedicated CALGB data managers. This organizational structure is further strengthened by close interaction with the CALGB biostatistics and data management center under the direction of Dr. Stephen George who is also director of biostatistics for the Duke Cancer Center, Scientifically, Duke has active cadre members in all the disease and modality related CALGB committees. Duke investigators serve as study chairs on Phase III trials in AML, stage IV breast cancer, the national high priority trial of bone marrow transplant in the adjuvant treatment of breast cancer patients (9082), as well as numerous Phase II studies. Duke is also a center for Phase I studies for pharmacology/experimental therapeutics. This has been further strengthened by the recruitment of Dr. Michael Colvin to become Director of the Cancer Center. Furthermore, Dr. Harvey J. Cohen, Director of the Aging Center has become an active member of CALGB and was instrumental in the formation and leadership of a working group evaluating cancer and aging. The recruitment of Dr. David Harpole in Thoracic Surgery, led to Duke becoming a major site for participation in CALGB surgical trials. Multimodality support has also been provided by active participation from other members of surgical oncology as well as radiation oncology, pathology, and correlative sciences. Areas of expansion by Duke investigators within CALGB over the next grant cycle will be particularly targeted to multimodality trials, Phase I studies, bone marrow transplant trials, and the continued participation in ongoing phase II and III trials. In addition, our participation in community trials addressing minority issues, gero-oncology, and cancer control will expand with the participation of Dr. Barbara Rimer and Dr. Colleen McBride. As a leading institution in CALGB activities over the last decade, Duke is looking forward to funding support appropriate to our current and anticipated level of patient accrual and scientific involvement in CALGB trials during the next grant cycle.
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