The Clinical Trials Units of the UAB Center for Injury Science designs, leads, coordinates, and conducts clinical trials and other prospective clinical research across UAB and beyond. Led by Dr. Jan Jansen and Mr. Shannon Stephens, the program has particular expertise in large, multicenter trials; studies of time-critical and complex interventions; emergency research; and trials conducted under Exception from Informed Consent (EFIC).
Although injury remains at the core of our mission, our clinical trials infrastructure extends well beyond trauma. We support investigators and research programs across a broad range of clinical specialties and work with academic investigators, federal agencies, research networks, and industry partners.
Our work spans the entire clinical trial lifecycle, from development of the research question and study design through protocol development, regulatory approvals, trial implementation, site management, data collection, and dissemination of results. We can support individual investigators developing a new study, serve as the coordinating center for multicenter research, provide specialized regulatory and EFIC expertise, or augment an existing study team with 24/7 research operations.
Complex and Time-Critical Clinical Trials
Clinical trials involving critically ill patients, complex interventions, or time-sensitive treatments present challenges that differ substantially from those encountered in conventional clinical research. Patients may be critically ill, treatment decisions may need to be made within minutes, eligible populations can be difficult to identify prospectively, and interventions may need to be delivered before informed consent can reasonably be obtained.
Clinical Trials Unit has extensive experience addressing these challenges. Areas of expertise include:
- Multicenter randomized clinical trials
- Pragmatic and large simple trials
- Trials of drugs, biologics, blood products, medical devices, and complex clinical interventions
- Prehospital and early in-hospital research
- Exception from Informed Consent (EFIC)
- Bayesian and adaptive trial designs
- Central trial coordination and site management
- Community consultation and public disclosure
- 24/7 screening, enrollment, and protocol implementation
- Biological sample collection, processing, and translational research support
Leading Multicenter Clinical Trials
The Center for Injury Science has developed substantial expertise in the design, leadership, and coordination of large multicenter clinical trials. Our investigators lead major national and international research collaborations, supported by an experienced team providing centralized trial management, site coordination, regulatory oversight, and operational support.
Recent examples include the international Trauma and Prothrombin Complex Concentrate (TAP) Trial, a randomized, double-blind trial conducted across 90 trauma centers in the United States, United Kingdom, and Australia, and the NHLBI-funded Trauma Resuscitation with Group O Whole Blood or Products (TROOP) Trial, a multicenter randomized trial comparing low-titer group O whole blood with blood-component therapy for life-threatening traumatic hemorrhage.
Our experience also extends to the coordination of multicenter device studies, including MOBI, which evaluated non-invasive technology for monitoring traumatic intracranial hemorrhage. Across these studies, CIS provides the scientific leadership and operational infrastructure needed to coordinate complex research across multiple institutions, ensure consistent protocol implementation, and maintain high standards of trial conduct and data quality.
Participating in Multicenter Clinical Trials
In addition to leading and coordinating multicenter studies, the Center for Injury Science serves as a participating site for clinical trials led by other investigators, institutions, and national research networks, including the Linking Investigations in Trauma and Emergency Services (LITES) Network. Our experienced clinical research teams provide the infrastructure necessary to implement complex study protocols, support timely patient identification and enrollment, and ensure high-quality data collection and regulatory compliance.
Our portfolio includes TOWAR, investigating resuscitation strategies for traumatic hemorrhage; REVIVE, evaluating an investigational device for temporary control of life-threatening intra-abdominal hemorrhage; FIT-BRAIN, evaluating early fresh frozen plasma administration for moderate-to-severe traumatic brain injury; VIBRANT, investigating valproic acid as a treatment for traumatic brain injury; and PREEVEnT, examining early plasma resuscitation following severe thermal injury. Other studies include AURORA, focused on acute kidney injury, and investigations of emerging wound technologies, including WounDx and studies of friction-injury management.
Together, these collaborations demonstrate CIS's ability to contribute as a reliable, high-quality research site across a broad range of studies involving pharmaceuticals, blood products, biologics, medical devices, and diagnostics, from prehospital and emergency care through intensive care and recovery.
Beyond Trauma
Although the Center for Injury Science has particular expertise in trauma, emergency care, burns, and critical illness, Clinical Trials & Research Operations serves investigators well beyond the field of injury research.
Our infrastructure has supported clinical studies in areas including transplantation, nephrology, cardiac surgery, emergency medicine, anesthesiology, neurology, pathology, and microbiology.
Current examples illustrate this broader role. The program supports a Vantive-sponsored Phase 3 study evaluating Prismocitrate 18 and the PrisMax System in patients receiving continuous renal replacement therapy. The program is also supporting FREXERA, a Sanofi-sponsored Phase 2/3 study evaluating frexalimab versus tacrolimus in adults undergoing kidney transplantation. These studies demonstrate that the research infrastructure developed within the Center for Injury Science can be deployed effectively in other highly specialized areas of clinical research.
Our approach is deliberately flexible. We can support an entire study or complement an investigator's existing research team. Support can range from around-the-clock screening and enrollment to regulatory support, biological sample collection and processing, protocol-specific procedures, data collection, and longitudinal follow-up.
National Expertise in Emergency Care Research and EFIC
The Center for Injury Science has particular expertise in research conducted under the federal regulations governing Exception from Informed Consent (EFIC). These regulations make important emergency research possible when patients face life-threatening conditions, available treatments are unproven or unsatisfactory, and prospective informed consent cannot feasibly be obtained.
A critical component of EFIC research is community consultation and public disclosure (CC/PD). CIS has developed scalable approaches to CC/PD that combine traditional community engagement with innovative digital methods capable of reaching large and diverse populations. An important focus of our work is the systematic evaluation and improvement of CC/PD methods, including research into how best to engage communities, assess their perspectives, and ensure that consultation is meaningful, representative, and effective. We work closely with Institutional Review Boards (IRBs), research ethicists, and other stakeholders to address the ethical, regulatory, and practical challenges of conducting emergency research.
Increasingly, CIS provides this expertise as a centralized service to major multicenter emergency-care trials across the United States. We have led or supported CC/PD activities for studies including KESETT, WINDSURFER, Pedi-PART, and MATIC-2, in addition to EFIC trials conducted directly through UAB.
These studies span a wide range of emergency conditions. KESETT evaluates treatments for established status epilepticus; WINDSURFER investigates non-invasive respiratory support in acute respiratory failure; Pedi-PART compares approaches to prehospital airway management in critically ill children; and MATIC-2 examines transfusion strategies for children with life-threatening traumatic bleeding.
By combining practical experience in multicenter EFIC implementation with methodological research and close collaboration with IRBs and ethicists, CIS aims not only to support the efficient and rigorous conduct of emergency research, but also to advance best practices in community consultation and public disclosure while keeping participating communities central to the process.