| Department
of Anesthesiology Clinical Trials Program
Since July 1, 2001, the Department of Anesthesiology has maintained its own industry-sponsored Clinical Trials Program (CTP) with University of Pittsburgh’s Vice Chair of Clinical Research, Jacques E. Chelly, MD, PhD, MBA, as the Program Director and Rose Lanzo, BS, CRC, CRTT as Clinical Trials Manager. This growing and self-contained program has been designed to provide the department with all of the services necessary for faculty members, as both principal investigators and sub-investigators, to start and follow through with clinical trials. This includes contract and budget negotiations, clinical research coordinator (CRC) support, UPMC Clinical Trials Office (CTO) compliance, and accredited Institutional Review Board (IRB) compliance. The CTP is also committed to developing new study opportunities by promoting departmental resources to the pharmaceutical industry as a whole.
To ensure satisfaction of all legal and ethical requirements, program staff prepares research protocols and patient consent forms, verifies compliance with federal regulations and Good Clinical Practices, and submits IRB materials. The program also works very closely with the UPMC Clinical Trials Office in order to manage all the legal and fiscal aspects of the industry sponsored clinical trials by developing and negotiating contracts and budgets. The Department of Anesthesiology’s Clinical Trials Program staff then oversees the trial itself by training and supervising seven full-time clinical research coordinators, coordinating trial initiation, facilitating and monitoring patient enrollment and study progress, and sustaining quality control of data collection and record keeping.
During the 2007 Academic year we are extremely pleased to report that CTP was involved in approximately 23 clinical trials involving over 30 faculty members at 6 UPMC sites with the sponsorship of the following companies: Bayer, Johnson & Johnson, Organon, Pfizer, Hospira, Wyeth, Ortho-Biotek, Progenics, Merck, and many more. Fiscal Year 2006-07 contracted grants totaled approximately $3,000,000.00
If you would like additional information on the Clinical Trials Program here at the University of Pittsburgh, Department of Anesthesiology, please contact Rose Lanzo, BS, CRC, CRTT.
Contact Information:
Rose Lanzo, BS, CRC, CRTT
Clinical Trials Manager
Department of Anesthesiology
UPMC Shadyside, Suite M140
5230 Centre Avenue
Pittsburgh, PA 15232
412.623.2706 (telephone)
412.623.4188 (facsimile)
E-mail: albrrx@anes.upmc.edu |