print   Bookmark and Share  |  RSS  |  A  A  A

Clinical Trials Office

Search for open clinical trials

Director: Kathleen Rodger, RN, BSN, MS
Medical Director: Bassel El-Rayes, MD

Description

The Winship Cancer Institute Clinical Trials Office (Winship CTO) is a Shared Resource of the Cancer Institute. It supports clinical research by providing central coordinating resource for the initiation, conduct, oversight, and tracking of clinical research involving cancer patients supported by clinical research staff and regulatory management to ensure compliance with the IRB, FDA and external sponsors. 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 Winship Clinical Trials Office is led by an executive team consisting of Kathleen Rodger, RN, BSN, MS and Bassel El-Rayes, MD, Medical Director.
 
Ms. Rodger has more than 25 years of work in the field of oncology and extensive experience managing clinical research operation.  She is responsible for the overall supervision and administration of the CTO.  Ms. Rodger directly manages three assistant directors.  Faye Safavi, MSHA, is the Assistant Director of Clinical Operations and directly supervises the clinical research coordinators and clinical research nurses.   Dixil Francis, BS, MPH, is the Assistant Director of Regulatory Affairs and directly supervises the regulatory specialists in the Winship CTO.  The Assistant Director of the Oncology Reporting Office is Ellen Wojcik, MBA.  She is the administrator of the clinical trials management system database and directly supervises the database specialists and registration specialist.  Dr. El-Rayes, MD, is a medical oncologist and is an experienced clinical trialist.  He is an associate professor of Hematology and Medical Oncology in the Emory University School of Medicine and also serves as director of the GI Oncology Translational Research Program of Winship.  He works closely with Ms. Rodger and the leadership team of the Winship CTO to ensure compliant study conduction, standardization of operations of oncology clinical trials throughout Winship.
 
The long-term goal of the Winship 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 Winship CTO is to help develop and support Institutional clinical research studies, particularly phase I and institutional studies.
 
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 Education in the School of Nursing; and the Departments of Epidemiology and Biostatistics in the School of Public Health. The Winship CTO has collaborations with the Imaging and the Bio-repository Cores. The Winship CTO has supported clinical research from Emory University that has lead to numerous publications since 2002.

Objectives

The Winship 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 Winship CTO pursues the following specific objectives:
  1. To provide infrastructure support for the development and implementation of human clinical research protocols relevant to cancer.
  2. 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.
  3. To provide disease management teams with regulatory support to ensure compliance with Good Clinical Practice, the IRB, FDA and other regulatory agencies.
  4. 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.
  5. To support the Clinical Translational Research Committee in executing the functions of the Protocol Monitoring and Review System.
  6. To support the Monitoring Committee in executing the Data Safety Monitoring Plan.
  7. To provide education and training for staff and faculty involved in clinical research. 
  8. To disseminate information on active clinical trials involving cancer patients to the Emory community and patients and referring physicians in Georgia.

 
Winship Clinical Trials Office (CTO) Authority and Purview
The Winship Clinical Trials Office 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. monitor overall accrual and accrual to each of the protocols  open at Winship;
  3. serve as a liaison with the Emory School of Medicine Clinical Trials Office that negotiates budgets for clinical trials and ensure billing compliance;
  4. serve as a liaison with the Office of Sponsored Research that negotiates contracts with external sponsors of clinical trials at Emory.
The Winship 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 Winship 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 coordinators across all of Winship is assisted and supervised by the Director and her 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.
 
The CTO has begun working closely with the Winship 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.
 
  
Capabilities/Services
Regulatory Affairs; Data Management; Database Support; Compliance; Budget and Contracting; Research Specimen Collection; and Data Management Training and Education.

Please acknowledge the Core Facility in all publications as follows:
Research reported in this publication was supported in part by the Clinical Trials Office Shared Resource of Winship Cancer Institute of Emory University and NIH/NCI under award number P30CA138292. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.