UCSD Clinical Trials Center (CTC)

The Center's Director, Dr. Joe Ramsdell, is a nationally recognized leader in pulmonary disease and clinical investigation. The CTC is responsible for an average of 20 new protocols per year and averages 80-90 research subject visits per month. Approximately 60% of the protocols are for obstructive airway diseases. The CTC is available to faculty and fellows to have access to research facilities with trained staff in the FDA Good Clinical Practice Guidelines for conduct of clinical trials.

The CTC facility amenities include two locations (campus and Hillcrest Medical Center) with over 3200 sq. feet of space. Each facility has three subject examination rooms, clinical laboratory for blood drawing, equipment for pulmonary function tests and centralized medical record storage. In addition, the Hillcrest CTC has a complete pulmonary function (described in detail on page 65). Study coordinators have office space, individual personal computers that are networked to the UCSD School of Medicine by electronic mail, Medline searching and world wide web access. Software includes centralized scheduling, word processing, spreadsheets and database for subject recruitment. The CTC local area network with the computerized Study Management System permits the study coordinators to monitor all aspects of a clinical trial including recruitment, scheduling, data collection, data management, data analysis and study close out. Through the UCSD wide area network, the Center has electronic capabilities to access UCSD Medical Center's subject databases for laboratory data. Software is licensed to the CTC and costs are absorbed by the facility. The Center currently employs five study coordinators, two data management/clinical trial assistants, two receptionist/recruiters, a business manager, technical laboratory director and research supervisor. In addition to the full time staff, the CTC draws from a temporary pool of medical assistants, and administrative assistants to assist in variable increases in workload. The Center's Research Associates and Study Coordinators are proficient in all aspects of clinical research, including study design, recruitment and retention, and data collection, as well as various medical procedures and testing required by the study design and data management.

CTC Trials Management System: The CTC maintains a computerized Recruitment Database and Study Management System. The database resides on the network system and allows for record sharing, real time data entry and multiple-user access. The system includes study-specific information and a calendar system. Input of data is through user-friendly menus and may be updated quickly. The study management system is specifically designed to track clinical trials, including procedures by visit, maintain subject demographics, medical history, and medications, as well as detailed unscheduled contact tracking and scheduled phone contact listings. The database is utilized for subject screening and early recruitment activities. Mailing labels for newsletters and appointment reminders may be quickly generated from the database.

The CTC Pulmonary Physiology Laboratory: Directed by Drs. Clausen and Ramsdell with Technical Director, Gerad Duffin, the CTC Pulmonary Physiology Laboratory has an established reputation for state of the art, comprehensive pulmonary physiologic testing. The Laboratory is staffed by NBRC Pulmonary Function credentialed staff with appropriate cardiac life support training. The Laboratory staff participated as a Center in the NHL GBI Registry for Patients with Alpha-1 Antitrypsin Deficiency and the NIH/FORTE study. The Laboratory has the ability to perform from an extensive menu of PFT and excerise tests. The Laboratory currently uses the following equipment to facilitate the required tests:

• Sensormedics V-MAX, V6200 Body Box
• Cardiosoft ECG
• Trackmaster model 425C extended Treadmill
• Ergoline 800S Ergometer
• Nitrous oxide Aerocrine meter