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Winship Cancer Institute Clinical Trials |
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Director: Edmund K. Waller, M.D., Ph.D., FACP, Medical Director of the Winship Cancer Institute Clinical Trials Office (WCI CTO) is Professor of Hematology & Medical Oncology and Director of the Bone Marrow and Stem Cell Transplant Center of Emory University. Dr. Waller is the primary liaison with clinical faculty conducting clinical research at the WCI. He serves as a member of two key oversite committees - the Clinical and Translational Research Committee for WCI, and the Conflict of Interest Committee for Emory Healthcare.
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Description
The Winship Cancer Institute Clinical Trials Office (WCI CTO) is a Shared Resource of the Cancer Institute. It supports clinical research by providing scientific review, prioritization, and monitoring of clinical trials involving cancer patients.
The WCI CTO is led by an executive team consisting of Edmund Waller, MD, PhD, Medical Director; Don Harvey, PharmD, Director of Phase I Research; and Rebecca Pentz, PhD, Research Ethicist, and Tom Olson, Chairman of the CTRC.
The long-term goal of the WCI CTO is to advance progress in cancer care through the support of high-quality, high-impact clinical research by Cancer Institute members. The focus of the WCI CTO is to help develop and support Institutional clinical research studies, particularly phase 1 and institutional studies
The Clinical and Translational Research Committee (CTRC) maintains the scientific integrity of clinical research conducted through the WCI CTO by ensuring that the scientific question being addressed is significant, that the study will yield new information relevant to the cancer problem, and that the conduct of the study, including accrual rates, is sufficient to answer the scientific question that it is addressing.
The WCI CTO supports clinical research activities of 101 investigators in:
Investigators represent the School of Medicine Departments of Hematology & Medical Oncology, Medicine, Pediatrics, Surgery, Radiation Oncology, Urology, and Pathology; the Departments of Behavioral Science & Health Ed in the School of Nursing; and the Departments of Epidemiology and Biostatistics in the School of Public Health. The WCI CTO has collaborations with the Imaging and the Bio-repository Cores. The WCI CTO has supported clinical research from Emory University that has lead to 56 publications since 2002.
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Objectives
The WCI CTO manages the overall process of subject screening, consent, registration, data entry and regulatory document submission for clinical research studies involving cancer patients. To achieve the goals of the WCI CTO pursues the following specific objectives
- To provide infrastructure support for the development and implementation of human clinical research protocols relevant to cancer.
- To provide the disease management teams with administrative support to facilitate subject screening, consent, registration, study-specific tests and treatments, response and toxicity assessment, and data entry.
- To provide with disease management teams with regulatory support to ensure compliance with Good Clinical Practice, the IRB, FDA and other regulatory agencies.
- To monitor overall accrual of subjects on therapeutic and non-therapeutic cancer-related clinical trials and provide support for the Cancer Institute Director and leaders of the Scientific Programs in monitoring accrual to specific protocols.
- To support the Clinical Translational Research Committee in executing the functions of Protocol Monitoring and Review System.
- To support the Monitoring Committee in executing the Data Safety Monitoring Plan.
- To provide education and training for staff and faculty involved in clinical research.
- To disseminate information on active clinical trials involving cancer patients to the Emory community and patients and referring physicians in Georgia.
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Phase I Research Program
Phase I leader Donald Harvey, PharmD along with Medical Directors Sagar Lonial, MD and John Kauh, MD lead WCI efforts to expand and refine clinical trials using pharmacokinetic, pharmacodynamic and pharmacogenomic endpoints. The phase I unit will operates out of the WCI infusion center, staffed with a dedicated team of nurses and medical assistants to ensure the efficient and complete conduct of phase I patient care and data collection.
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WCI CTO Authority and Purview
The WCI CTO is the central clearing house for the initiation, registration of clinical protocols involving cancer patients. It is authorized by the Cancer Institute Director to 1) support the disease management teams that include clinical investigators focused on specific cancer types; 2) support the CTRC; 3) to support the Monitoring Committee and ensure execution of the Data Safety Monitoring Plan; 4) Monitor overall accrual and accrual to each of the protocols open at the WCI; 5) serve as a liaison with the Emory School of Medicine Clinical Trials Office that negotiates budgets for clinical trials and ensure billing compliance; 6) serve as a liaison with the Office of Sponsored Research that negotiates contracts with external sponsors of clinical trials at Emory.
All clinical research involving cancer patients at Emory, including therapeutic interventional trials, cancer prevention trials, cancer epidemiology trials, and laboratory studies involving samples from cancer patients must be submitted to the CTRC for entry into an electronic database (Oncore) prior to being submitted to the IRB.
The WCI CTO has evolved to become a less centralized system. Disease sites are categorized as either Medical Oncology or Hematology, with three disease teams within each group. The creation of these teams has stimulated greater interaction, communication and teamwork among the faculty and research staff facilitating clinical trials. These changes are enabling us to increase efficiency and streamline our processes as we continue to pursue our commitment to patient care.
The CTO has begun working closely with the WCI referral office to improve the efficiency in which patients are identified as potential candidates for clinical trials. The referral will identify patients through a questionnaire administered to patients scheduling into the clinic. This questionnaire will be available as a research protocol, with data collected after giving verbal consent. Information collected through the referral office will be reviewed during disease team meetings on a weekly basis, identifying potentially qualifying subjects prior to their office visit.
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Capabilities/Services
Regulatory Affairs; Data Management; Database Support; Scientific Protocol Review; Data and Safety Monitoring; Compliance; Budget and Contracting; Research Specimen Collection; and Data Management Training and Education.
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