In 1995, the Clinical Trials Service Unit (CTSU) in the Division of Cardiology was founded by the current CTSU Director, Jeffrey Probstfield, M.D. Dr. Probstfield brought his years of experience in clinical trials training to direct the CTSU to this day. Since its more humble beginnings, the CTSU has grown to occupy 4800 square feet and has 12 offices and 2 large conference areas. In addition, Kelley Branch, MD, MSc joined CTSU in 2012 as the Associate Director.
The focus of activities in the unit has been to identify, support (manage and monitor) clinical centers for large multi-center clinical trials for national and international multi-center clinical trials. Each project or trial is directed by a faculty-level individual and managed and supported by a lead project coordinator. Depending on the trial, the responsibilities of the project coordinators may involve any or all of the following: gathering regulatory documents, developing budgets, site identification and vetting, training, evaluation of site data reports, monitoring of recruitment, adherence to protocol, follow-up of cohort, monitoring visits to clinical sites, primary communication and resource for clinic sites, development of tools, forms and worksheets.
The CTSU also works closely with several coordinating centers in conducting large scale trials such as the recently completed AIM-HIGH, ORIGIN, and the ACCORD trials. Over 20 trials have been supported by CTSU which spans from the RESOLVD trial to the most recently completed ACCORD and AIM-HIGH trials.