Clinical Trials Office at Winship

The Clinical Trials Office at Winship Cancer Institute advances progress in cancer care through the support of quality, high-impact clinical research providing patients with access to innovative care options.

The Clinical Trials Office at Winship (CTO) provides comprehensive, centralized infrastructure to support clinical and translational research. The CTO facilitates the conduct of high-quality clinical research involving cancer patients by providing a central comprehensive management service.

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.

Photo of  Edmund K. Waller, MD, PhD, FACP
Edmund K. Waller, MD, PhD, FACP

Edmund K. Waller, MD, PhD, FACP

Interim Associate Director of Clinical Research
Winship Cancer Institute of Emory University

Dr. Waller specializes in bone marrow transplants for acute leukemia, myelodysplastic syndrome, myeloproliferative neoplasms, lymphoma, aplastic anemia, sickle cell disease and in the management of graft-versus-host disease.

Photo of  R. Donald Harvey, PharmD, BCOP, FCCP, FHOPA
R. Donald Harvey, PharmD, BCOP, FCCP, FHOPA

R. Donald Harvey, PharmD, BCOP, FCCP, FHOPA

Director, Phase I Clinical Trials Program
Winship Cancer Institute of Emory University

At Winship Cancer Institute, Dr. Harvey serves as director of the Phase I Clinical Trials Unit, and as medical director of the Clinical Trials Office.

Photo of  Amy M. Overby
Amy M. Overby

Amy M. Overby

Director, Clinical Trials Office
Winship Cancer Institute of Emory University

Ms. Overby is responsible for providing expertise and strategic direction to all aspects of cancer specific clinical research supported by the Winship Clinical Trials Office,

Photo of  Lydia Cox, MS
Lydia Cox, MS

Lydia Cox, MS

Senior Administrator, Protocol Review and Monitoring System
Winship Cancer Institute of Emory University

Ms. Cox is responsible for protocol registration and monitoring system aspects of the Clinical Trials Office at Winship Cancer Institute and its affiliated sites.

Photo of  Lindsay Johnson, MPH, CCRC
Lindsay Johnson, MPH, CCRC

Lindsay Johnson, MPH, CCRC

Interim Senior Administrator, Quality Management, Clinical Trials Office
Winship Cancer Institute of Emory University

Ms. Johnson provides oversite to the Quality Management Department of Winship Cancer Institute Clinical Trial Office.

Photo of  Amanda Lesinski, BS
Amanda Lesinski, BS

Amanda Lesinski, BS

Assistant Director, Regulatory Affairs, Post-Activation, Clinical Trials Office
Winship Cancer Institute of Emory University

Ms. Lesinski is responsible for the oversight of the regulatory post activation for the 15 Treatment Modality Working Groups (TMWG) in the Clinical Trials Office at Winship Cancer Institute.

Photo of  Ashlea Moore, CCRC
Ashlea Moore, CCRC

Ashlea Moore, CCRC

Senior Program Manager, Training Education and Outreach, Clinical Trials Office
Winship Cancer Institute of Emory University

Ms. Moore is responsible for managing and facilitating research related training and education for staff within the Clinical Trials Office at Winship Cancer Institute and its affiliated sites.

Photo of  Pauline Newlands, BS
Pauline Newlands, BS

Pauline Newlands, BS

Assistant Director, Clinical Research Staff, Clifton Campus, Clinical Trials Office
Winship Cancer Institute of Emory University

Ms. Newlands is responsible for supervision of the research staff coordinating the clinical trials at Winship Cancer Institute's Clifton campus.

Photo of  Kim Nguyen, BS
Kim Nguyen, BS

Kim Nguyen, BS

Assistant Director, Regulatory Affairs, Trial Activation Clinical Trials Office
Winship Cancer Institute of Emory University

Ms. Nguyen is responsible for the oversight of the regulatory and compliance for clinical trials study start-up and activation process in the Winship Cancer Institute Clinical Trials Office and affiliate sites.

Photo of  Leann Hassen Schilling, MPH, CCRP
Leann Hassen Schilling, MPH, CCRP

Leann Hassen Schilling, MPH, CCRP

Assistant Director, Clinical Research Staff, Affiliated Sites, Clinical Trials Office
Winship Cancer Institute of Emory University

Ms. Schilling is responsible for supervision of the research staff coordinating the clinical trials at the Winship Cancer Institute (Clifton Campus) and Emory University Hospital Midtown.

At Winship, our patients have access to clinical trials for virtually every cancer type. In 2021, we enrolled more than 900 patients in over 300 clinical trials.

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