The UAB Department of Surgery recently established a new research unit to design and conduct clinical trials. 

Jan Jansen

Under the leadership of the Division of Acute Care Surgery’s Jan Jansen, MBBS, Ph.D., MBBS, Ph.D., and Shannon Stephens, EMTP, CCEMTP, the new Clinical Trials Unit functions as part of the Department of Surgery’s Research in Surgery and Epidemiology program and the UAB Center for Injury Science.

Jansen is as an associate professor of Acute Care Surgery and associate vice chair for clinical trials for the Department of Surgery, as well as the director of the Center for Injury Science, while Stephens serves as the Center’s executive director.

The CTU aims to address important health questions in an increasingly challenging scientific, legal and regulatory environment. The unit’s leadership boasts nearly two decades of experience in clinical trial operations with particular expertise in operationalizing studies of time-critical and complex interventions, such as emergency procedures and medical devices. These trials present special problems for evaluators, including small eligible populations, patients with incapacity that may require exception from informed consent, and the need to enroll patients at any time of the day or night.

The CTU provides two key services. First, it executes clinical trials, regardless of whether the trial is investigator-initiated or industry-sponsored, and whether it originated at UAB or elsewhere.

Shannon Stephens

A cornerstone of the CTU is its Research Assistant Program, which has been operational for several years and has helped to operationalize more than 50 trials and to enroll more than 22,000 patients. They have received extensive training in data collection, good clinical practices, human subjects protection, HIPAA regulations and how to interact with the hospital's clinical staff. RAs collect, organize and maintain data and are trained in collecting and processing biological samples. They are available 24/7 to screen and enroll patients and can also serve to complement existing research staff by extending the hours that current studies can screen, collect data and gather and process biological samples. This enhancement is available at a fraction of the cost of on-call and overtime pay for existing staff.

In addition to executing clinical trials, the CTU can also help investigators design their clinical trials by providing access to experienced methodologists, regulatory officers, trial managers and biostatisticians. The unit has particular expertise in conducting exception from informed consent studies and clinical trials requiring innovative statistical approaches, such as Bayesian designs.

Learn more about the CTU and the Center for Injury Science here. For more information or to discuss any questions, concerns or ideas, email cis@uab.edu.