Posttraumatic stress disorder (PTSD) and traumatic brain injury (TBI) are two common, serious problems faced by military service members deployed to the conflicts in Iraq (Operation Iraqi Freedom [OIF]) and Afghanistan (Operation Enduring Freedom [OEF]). Although prevalent and, in many cases, associated with substantial functional impairment, PTSD and TBI are also two of the less well understood neuropsychiatric disorders in many aspects ranging from epidemiology to natural history to prevention to treatment.
To address multiple PTSD and TBI research gaps, a Clinical Consortium will be established, consisting of 10 Clinical Study Sites to conduct relevant, meritorious research in this area. The Clinical Consortium-Coordinating Center (CCCC), located at the University of California San Diego (UCSD) and led by Principal Investigator Murray B. Stein MD, MPH, will take responsibility for coordinating the efforts of the Clinical Study Sites by providing the requisite scientific and strategic leadership, combined with administrative, regulatory, and logistical support to fulfill the Consortium¿s overarching aims. A key role of the CCCC will be to facilitate the rapid selection, design, execution, and analysis of clinical studies within the Consortium. It will provide the informatics (including data security and storage), statistical, and oversight functions necessary to initiate, coordinate, and monitor Consortium studies at the Clinical Study Sites.
Our vision of the CC is that its priority will be the design and conduct of well-powered clinical trials aimed at improving detection, diagnosis and treatment delivery, enhancing quality of life and reintegration into society and, where feasible, testing preventive strategies. The primary foci of research will be PTSD and related mental health problems, mild TBI, and ¿ whenever possible ¿ all of these in the same studies. Although it will also have the capacity to lead and coordinate Consortium efforts in studies focused on epidemiology, or on more mechanistic studies, the structure of the CCCC has been optimized for the design and execution of multi-site clinical trials among military-relevant populations. These may include trials in civilian samples where acute assessment and longitudinal evaluation is possible (e.g., persons seen in the Emergency Department following mild TBI), in military veterans where chronicity is already present and the aim is to reduce morbidity and improve functioning, and, if feasible, in acute military settings.
Aims of the CCCC
The overarching goal of establishing the PTSD/TBI Clinical Consortium is to combine the efforts of the nation¿s leading investigators to bring to use novel treatments or interventions that will ultimately decrease the impact of military-relevant PTSD and TBI and improve the function, wellness, and overall quality of life for Service members as well as their families, caregivers, and the American public.
In keeping with these overarching aims of the Clinical Consortium, our proposed Clinical Consortium-Coordinating Center (CCCC) has the following aims:
1. To coordinate the efforts of the Clinical Study Sites by providing scientific, strategic, and administrative (including budgetary and regulatory) leadership and support to fulfill the Consortium¿s overarching aims (i.e., clinical studies addressing military-relevant PTSD and TBI research gap areas). This will include liaising and integrating activity with USAMRMC personnel and with DoD PTSD and TBI Centers of Excellence. The Administrative Core of the CCCC will lead the efforts necessary to achieve these aims.
2. To propose and, with input from the Clinical Study Sites and DoD, adopt a Uniform Dataset. This Uniform Dataset will consist of key variables (e.g., demographic, injury parameters, neurocognitive function, psychiatric symptoms, functioning, health-related quality of life) that will be collected on all subjects across all studies. The Uniform Dataset will be supplemented with study-specific measures as indicated. Establishment of a Uniform Dataset will provide heretofore unimagined opportunities for research integration across PTSD, TBI, and combined PTSD-TBI.
3. To facilitate the rapid selection, design, and execution of clinical studies within the Consortium. To meet this aim, the CCCC, through its Data Core (led by Ronald G. Thomas, PhD) will provide training to Clinical Study Site personnel in study-specific procedures, and will coordinate and provide all informatics (including data transmission and storage) and biostatistics support necessary to carry out and integrate multi-site clinical trials. Included will be electronic (remote, through eCRF capabilities) and on-site data and quality monitoring. Security of data will be a paramount focus. The Data Core of the CCCC will lead the efforts necessary to achieve these aims and will be enabling a means to request data via the Consortium webpage (http://intrust.ucsd.edu/).
In summary, the PTSD-TBI Clinical Consortium will embark on 5 years of funded research to improve our understanding of the longitudinal course, etiology, pathophysiology and, especially, the treatment of PTSD, TBI (principally mild TBI), and their interface.