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For the last several years, we have shifted the focus of the clinical research effort in cancer. The Cancer Center’s central goal is to impact cancer treatment through the translation of basic advances in our understanding of cancer to the clinic.
Participation in cooperative group research certainly allows Tufts Medical Center investigators and their patients to take part in research that may contribute to overall progress in cancer therapy, but it does not provide a uniquely identifiable intellectual outlet for Tufts Medical Center Cancer Center members to impact the provision of cancer care.
To this end, we have begun to re-direct our clinical research effort to create a clinical research apparatus that does two things:
The Neely Center for Clinical Cancer Research (NCCCR) is the core facility of the Cancer Center dedicated to coordinating all aspects of oncology and hematology clinical research in compliance with NIH rules, FDA regulations and “Good Clinical Practice” guidelines.
In operation since January 2003, the center initially coordinated all aspects of cancer clinical research through the division of hematology-oncology. Over the last year, reorganization has integrated other cancer clinical research efforts of the Cancer Center into the NCCCR.
The Cancer Center’s clinical core includes support for protocol design, conduct, and ancillary services as one entity. Biostatistics exists as a more independent aspect of the NCCCR, serving both clinical and basic science design and data analysis.
The Cancer Center's clinical core services include the Biostatistics Core, also known as the Design and Data Resource Center or DDRC; the NCCCR; the Tumor Registry, which is responsible for data collection outside of clinical trials; and the new Tissue Repository, part of the Research Pathology Core.
Our efforts to re-design clinical research positions these core services to support clinical trials in cancer, as well as to enhance translational applications from our basic scientists. These Cancer Center elements function closely with translational infrastructure elements developed as part of the Clinical Translational Science Institute (CTSI). The DDRC and Tumor Repository straddle these two complementary clinical research efforts.
Tufts Medical Center’s clinical trials program has conducted cancer clinical trials for four decades. Until recently the major emphasis has been in providing consolidated protocol management for all clinical trials in adult and pediatric cancer services at Tufts, particularly through cooperative group participation.
Major programs include longstanding cooperative group agreements with the Eastern Cooperative Oncology Group (ECOG), the Gynecologic Oncology Group, and the Children’s Oncology Group. The ECOG program is one of the largest networks in the United States and supports programs throughout New England.
Participants on the Boston Tufts campus in clinical cancer research include Tufts University, Tufts Medical Center, the Clinical Research Center at Tufts Medical Center, and the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University. The University and the Medical Center serve as an important hub for cooperative group trials in New England.
The Neely Center for Clinical Cancer Research (NCCCR) is located on the seventh floor of the South Building, the ambulatory Cancer Center. It is centrally located within the Clinical Care Facility of the Cancer Center, adjacent to the Division of Hematology/Oncology, the Breast Health Center and the Breast Imaging Center.
The Facility includes 10 offices and a centralized audit area/conference region with shared computer resources and access to all hospital information systems. Storage for active protocol files resides within the center. The NCCCR has immediately adjacent conference capacity for meetings of up to 30 individuals. Telemedicine capability exists for joint protocol discussions where desirable with affiliates.
Established in 2002, the NCCCR’s initial priority was to coordinate the activities, credentialing and practices of all principal investigators conducting non-gynecologic and non-pediatric studies. Currently, integration of pediatric cancer protocols conducted at the Tufts Medical Center, gynecologic oncology and Neurologic oncology trials are now complete. Now, all cancer trials at Tufts Medical Center are coordinated and overseen by the Neely Center. The NCCCR serves to keep a registry of all trials, insure institutional credentialing, provide continuing education and training, monitor accrual and data monitoring, and summarize and publicize trials.
The NCCCR’s mandate includes the development and implementation of Tufts MC’s investigator initiated clinical trials, NCI–sponsored cancer clinical trials and support of Tufts MC’s role as a Main Member Institution for ECOG, and support and development of industry–sponsored trials that are programmatically important for the various clinical programs.
Here are the center’s specific functions:
1. The Biostatistics Core (Design and Data Resource Center) provides input into the design of protocols, statistical elements, and database needs for clinical and translational research.
2. The Biostatistics Core also aids in the statistical analysis of basic and clinical data.
3. The NCCCR is the clearinghouse for all cancer clinical trials. That is, it is the mechanism for clinical trial oversight, managing the roster of open studies, closing completed trials, publicizing available studies on the web site and making supporting documents available.
4. The NCCCR, with investigators, submits clinical trials for review, assists in consent form writing and development, and facilitates correspondence with IRB and the hospital contracting group to open clinical studies. This follows the initial review of trials by individual tumor boards in that disease area and their prioritization and approval by each respective tumor board.
5. The NCCCR also provides Clinical Research Coordinators (CRCs) and data management to enroll patients and conduct clinical studies.
6. The NCCCR effects compliance with regulatory agencies.
7. The NCCCR communicates with sponsors and facilitates their oversight of trials.
8. The NCCCR also provides continuing education, credentialing, seminars, and support for all research staff, and monitors institutional credentialing for participants
9. The Neely Center also plays an essential role for the Tufts Medical Center Cancer Center in providing regional access to trials by providing oversight and technical support for trials that can be conducted through the affiliate network.
Clinical Leaders of individual disease programs select protocols based on priority for completion within the disease program, and coordination by the center.
Protocols deemed high priority are placed on fast track for opening either through Tufts Medical Center IRB or through the CIRB processes in place at Tufts Medical Center, with the permission of the local IRB.
The organization allows coordinators and members to work directly with principal investigators for task assignment while reporting directly to administrative support for credentialing, education, procedural matters and personnel reviews. The development of a process of approval and consideration of funding opportunities for continuing education has improved staff training and expertise.
The director oversees strategic initiatives of the research center as determined by the Cancer Center Executive Committee, while the administrative director and her/his assistants oversee programs for cooperative groups, transplant and investigator initiated and industry-sponsored trials. The center has identified transplant studies as a particular subspecialty given the acuity and the complexity of day-to-day data management during the acute treatment.