Clinical Trials Office at Winship

Staffed by highly trained professional research personnel specializing in areas of clinical coordination, clinical data management, quality management, regulatory affairs, and specimen processing. The CTO supports the development, conduct, monitoring, and data management of all clinical research conducted at Winship. The CTO provides a supportive environment to conduct clinical trials in a cost-effective and efficient manner while ensuring compliance with Winship clinical trials standard operating procedures, Good Clinical Practice (GCP), Emory University Institutional Review Board (IRB), US Food and Drug Administration (FDA), other regulatory agencies and external sponsors. The CTO supports clinical research conducted across nine Winship facilities, satellite sites and affiliates.

Goals and Objectives

The long-term goal of the CTO is to advance progress in cancer care through the support of high-quality, high-impact clinical research by Winship Cancer Institute members. The focus of the CTO is to help develop and support institutional clinical research studies, particularly phase I and institutional studies. In 2009, the Phase I Clinical Trials Unit opened and is dedicated to advancing cancer research through a singular focus on caring for patients enrolled in phase I clinical trials.

The CTO supports clinical research at other Emory University Hospital sites, including Emory University Hospital Midtown, Emory Saint Joseph's Hospital, Emory Johns Creek Hospital, and Emory Proton Therapy Center. Additionally, support is provided at other area facilities where Emory investigators conduct clinical trials, including Atlanta VA Medical Center and Grady Memorial Hospital. Investigators represent the Emory University School of Medicine Departments of Hematology & Medical Oncology, Medicine, Pediatrics, Surgery, Radiation Oncology, Urology, and Pathology; the Departments of Behavioral Science & Health Education in the School of Nursing; and the Departments of Epidemiology and Biostatistics in the School of Public Health. The CTO has supported clinical research from Emory University that has led to numerous publications since 2002.

The CTO manages the overall process of subject screening, consent, registration, data entry and regulatory document submission and management for clinical research studies involving cancer patients. To achieve the goals, the CTO pursues the following specific objectives:

1. To support safe and ethical conduct of innovative and transformative clinical research.
2. To increasing awareness and trial access for patients in the catchment area, emphasizing underrepresented population.
3. To provide infrastructure support for the development and implementation of human clinical research protocols relevant to cancer.
4. 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.
5. To provide disease management teams with regulatory support to ensure compliance with GCP, IRB, FDA, and other regulatory agencies.
6. To monitor overall accrual of participants 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.
7. To support the Protocol Review and Monitoring Committee (PRMC) in executing the functions of the Protocol Review and Monitoring System (PRMS).
8. To support the Data and Safety Monitoring Committee (DSMC) in executing the Data and Safety Monitoring Plan (DSMP).
9. To provide education and training for staff and faculty involved in clinical research.
10. To disseminate information on active clinical trials involving cancer patients to the Emory community and patients and referring physicians in Georgia and bordering states.

Authority and Purview

The CTO is the central clearinghouse for the initiation and registration of clinical protocols involving cancer patients. It is authorized by the executive director of the Winship Cancer Institute to:

• support the disease management teams that include clinical investigators focused on specific cancer types
• monitor overall accrual and accrual to each of the protocols open at Winship
• serve as a liaison with Emory School of Medicine Clinical Trials Office that negotiates budgets for clinical trials and ensure billing compliance
• serve as a liaison with the Office of Sponsored Projects that negotiates contracts with external sponsors of clinical trials at Emory.

The CTO has developed policies and procedures to facilitate centralized management of cancer clinical studies across all departments in which subjects may be enrolled on cancer clinical trials. The CTO provides disease management teams with regulatory support to ensure compliance with GCP, the IRB, FDA, and other regulatory agencies. The CTO staff monitors study procedures to ensure regulatory compliance and provides regular instruction to new and current staff in these areas. Training of clinical research staff across all Winship is assisted and supervised by the Director and their leadership staff. The creation of these teams has stimulated greater interaction, communication and teamwork among the faculty and research staff facilitating clinical trials. Additionally, this structure has increased efficiency and streamlined processes.