The Clinical Trials Program was developed to coordinate and enhance clinical trial activities within the Department of Internal Medicine and to interact with other departments, institutions and industry sponsors seeking sites to conduct clinical trials.

Nelson Watts, MD, is an experienced clinical researcher who serves as the Medical Director of Clinical Trials and as the Department of Internal Medicine representative to the University's Executive Clinical Trials Committee which provides guidance to the University of Cincinnati Medical Center's (UCMC) Central Office of Clinical Trials.

Steve Salerno serves as the Clinical Trials Program Director. He coordinates the daily clinical trial activities of the Department including distribution of information regarding upcoming trials, regulatory affairs, contracting issues, investigator education and marketing efforts.

The Internal Medicine Clinical Trials Committee, with representation from each Division, meets regularly to discuss problems and solutions related to the clinical trials process in the Department of Internal Medicine.

Previous accomplishments of the Clinical Trials Program include:

• Provided assistance with university-wide Good Clinical Practice courses, Hot Topics in Research seminars and training for investigators and coordinators
• Organized the Clinical Research Skills Workshop for Investigators, which was jointly sponsored by UCP, UC COM and Pfizer
• Served on UCP HIPAA Task Force, which focused on the research component of HIPAA regulations
• Expanded the clinical trials database and increased the integration of this database with the departmental web site for listing of clinical trials on the Internet
• Utilized the department's contract specialist to review and negotiate confidentiality disclosure and clinical trial agreements
• Collaborated with the Department of Surgery, Department of Neurology and the College of Pharmacy to increase clinical trial activity, increase subject recruitment and improve efficiency of the clinical trial process
• Referred multiple trials to appropriate investigators within the Department of Internal Medicine
• Developed educational curricula for residents engaged in clinical research in association with the Residency Director, including course development for the design, conduct and regulation of clinical trials
• Continued bimonthly meetings of the Clinical Research Coordinators Group to encourage networking, problem-solving and continuing education for clinical trial-related issues
• Provided links between Divisions to share coordinators and maximize the use of skilled personnel
• Continued ongoing discussions regarding availability of research beds and other issues regarding clinical trial space
• Conducted educational workshops for investigators and administrative staff to provide an overview of the clinical trial process and to assist with contract negotiations, budget development and IRB submissions
• Assisted faculty at Raymond Walters College in the Clinical Research Certificate Program

Clinical Trials Program Committee Members

Nelson Watts, MD, Chairman- Endocrinology
Phone: (513) 475-7400
Email: Nelson.Watts@uc.edu

Steve Salerno, Program Director- Business Office
Phone: (513) 245-3415
E-mail: Steve.Salerno@uc.edu

Lynne Wagoner, MD - Cardiology
Andres Gelrud, MD - Digestive Diseases
Mark Eckman, MD, MS - General Medicine
Abdul-Rahman Jazieh, MD, MPH - Hematology/Oncology
Jonathan Bernstein, MD - Immunology
Dinesh Khanna, MD - Immunology
Judith Feinberg, MD - Infectious Diseases
Rita Alloway, PharmD - Nephrology & Hypertension
Ralph Panos, MD - Pulmonary
Kathy Qualls, MBA - Director, Budget/Finance