General Information, Clinical Trials Unit
Site Personnel and Infrastructure
The Georgetown University Hospital Division of Infectious Diseases Clinical Trials Unit (GUH-ID CTU) is located on the fourth floor of the Main Building, and is under the direction of Dr. Princy Kumar. Our Clinical Trials Unit is unique, as it is the only site in the Washington D.C. Metropolitan area that offers access to federal government, as well as pharmaceutical industry sponsored clinical trials. The Unit has extensive experience in the drug development of new anti-infective and antiretroviral agents, as well as epidemiological studies. Washington D.C. has one of the highest per capita HIV/AIDS populations, and the clinical trials unit has been actively involved in HIV/AIDS clinical research for the past fifteen years. The CTU receives federal funding from the National Institute of Allergy and Infectious Diseases (N.I.A.I.D.) as a member of the Adult AIDS Clinical Trials Group (AACTG) network and as a major site for the Women’s Intra-Agency HIV Study (WIHS).
Princy Kumar, MD
Dr. Princy Kumar, Professor of Medicine and Microbiology, and the Chief of the Division of Infectious Diseases, has been the site Principal Investigator (PI) for the ACTG CRS (Clinical Research Site) since the initiation of the collaboration between GUH and the Pittsburgh AIDS Clinical Trials Unit in 2001. She serves as the local site leader, and is the supervisor of all personnel within the Unit.
Dr. Kumar directs all of the research activities of the GUH-ID CTU and is responsible for selecting and implementing appropriate clinical trials, coordinating nursing personnel and the assignment of specific protocol related tasks. Dr. Kumar is also responsible for overseeing all protocol based patient care related issues in conjunction with the nursing personnel and the other site investigators. She works closely with the Regulatory Affairs Administrator to ensure the timely submission of protocols to the local Georgetown University IRB, and addresses any regulatory issues from the IRB or sponsor.
Joseph G. Timpone Jr., MD
Dr. Joseph Timpone, Associate Professor of Medicine in the Division of Infectious Diseases, is a site co-PI, and is a key personnel of the GUH-ID CTU. He develops the scientific agenda and coordinates the research activities of the Division of Infectious Diseases at GUH. He assists Dr. Kumar with the scientific leadership and is chairman of the Research committee, which is responsible for reviewing all protocols which will be performed at the Unit. The Research Committee meets on a monthly basis, and reviews all protocol-related issues including patient accrual, patient safety and adverse events, and selection of new protocols. He works closely with Dr. Kumar and the nursing personnel to address protocol based patient care related issues, as well as regulatory/IRB issues. He assists the study coordinator and research personnel with the educational aspects of the Community Advisory Board (CAB).
Mary Young, MD
Dr. Mary Young, Professor of Medicine in the Division of Infectious Diseases is the site PI of the N.I.H. funded Women’s Intra-Agency HIV Study (WIHS), which is a longitudinal study of HIV-infected women. (Refer to WIHS link). She is also one of the Chairpersons of the GUH Institutional Review Board (IRB). She provides advice and direction on IRB protocol submissions for the Unit and helps reinforce compliance with local IRB requirements. She also works closely to ensure appropriate representation of women in all trials performed at the Unit. She has contributed to and has been co-author for WIHS related presentations and publications.
Gayle Balba, MD, Jessica Rosen, MD (IRB), and Laura Coster, MD, are clinical faculty members in the Division of Infectious Diseases who will play an active role in the Unit’s research activities.
The other key personnel of the Unit include:
1) A Research Manager
2) Two Research Coordinators
3) Data Assistant
4) Regulatory Affairs Administrator and
5) Financial Administrator.
Clinical Research Nurses: Karyn Hawkins, RN, and Susan Vajda, RN
Research Manager: Maximiliano Menna
Data Assistant: Sujana Lalagari
Regulatory Affairs Administrator: Tessa Chaney Lamb
Financial Administrator: Mary Joseph