Warfighter Brain Health (WBH): Late and Long-Term Consequences of Head Impact Exposure and Concussion/Mild Traumatic Brain Injury (mTBI) on Brain Health

Purpose

This solicitation, issued by MTEC, represents a Request for Project Proposals (RPP) for MTEC support of the U.S. Army Medical Research and Development Command (USAMRDC) Combat Casualty Care Research Program (CCCRP). Strategic oversight for the award(s) supported by this RPP will be provided by USAMRDC. Project management will be conducted by the Congressionally Directed Medical Research Program (CDMRP). Portfolio management will be conducted by CCCRP.

This program aims to focus on determining the relationship between concussion/mild traumatic brain injury (mTBI) and brain health (BH) outcomes through a longitudinal human subject study assessment.

Scope of Work

The overall objective of the Warfighter Brain Health (WBH) program is to advance both knowledge and technology prototypes (e.g., training, tools, and practice guidelines for assessment, metrics, and interventions) that will reduce or eliminate acute to late and longterm effects from single and repetitive concussion/mTBI.

The U.S. Department of Defense (DoD) is seeking Solution Briefs for utilization of an already established and experienced Clinical Research Consortium (CRC) that will follow human subjects who have sustained a single or repeated concussion/mTBI to determine the relationship between concussion/mTBI, head impact exposures, and brain health outcomes. The CRC will be expected to interact with a Government Steering Committee with involvement from the USAMRDC and other stakeholders.

Solution Briefs submitted in response to this RPP are required to propose an already established and experienced CRC with a proven capability to recruit and maintain study individuals with TBI. Existing study data within the established network with the ability to follow this existing cohort is a requirement. The CRC must include an established network of experts from research, clinical, data management, policy guidance, etc. to meet the intent of this RPP.

In addition, desirable capabilities (not listed in order of importance) of the existing CRC infrastructure are that it currently has (at the time of submission of the Solution Brief):

• The capability to recruit, enroll, and follow a large population of control and TBI patients who have sustained a single or repeated concussion/mTBI (preferably upwards of 15,000 human subjects, if feasible);
• Access to study populations and data already collected from human subjects that supports the goals of this program and the ability to maintain and interpret these data;
• Ongoing relationships with both non-Government and DoD organizations that comprise the CRC network;
• Experience with sports- and military-related concussion;
• Access to military patients with brain trauma including repetitive concussion and/or head impact exposure;
• Access to human patients with concussion that are part of the National Collegiate Athletic Association (NCAA) to compare with military patients to build the capability of predictive models and strategies for clinical interventions; and
• The focus to be metric-driven with requirements for prototype development toward clinical interventions, endpoints, policy, and processes for mitigation and management of concussion, including the correlation of single and repetitive head impact exposure to Warfighter performance.

The end goal of the program is to deliver translatable processes, knowledge, and technology (i.e., training and practice guidelines for assessment and interventions) to better understand, optimize care for, and treat the immediate, longterm, and late effects of repetitive head impact exposure (i.e., jump zones, training activities, shipboard, etc.) and single and repetitive concussions/mTBI in order to maximize WBH. It is expected that outcomes will be transitioned to inform practice guidelines, training, and clinical trial endpoints.

Additional Points of Consideration

• Comprehensive and Integrated CRC with a Centralized Point of Contact (POC): It is required that Solution Briefs include an already established and experienced clinical research network with a proven capability to recruit and maintain study individuals with TBI. This program is NOT intended to develop a new research network. In other words, MTEC/DoD resources shall not be used to stand up clinical research sites; rather, the DoD expects to leverage capabilities already existing in the TBI research and development landscape. Agreements among TBI CRC members shall be handled by the CRC to the greatest extent possible. A centralized POC for the WBH CRC shall be named and will be ultimately responsible for official communication and deliverables. Offerors are expected to propose a WBH CRC comprising necessary qualified personnel, facilities, equipment, supplies, services, subcontractors, and related administrative and information technology support to accomplish the objectives.
• TBI Patient Population: It is expected that Offerors will have access to resources that can help overcome the challenges of TBI clinical research and trials. Difficulties in conducting studies in TBI patients include the significant variability in the nature and repetitiveness of TBIs and the overall health status of patients. TBI patient stratification, comparison to imaging, bio-samples, interim analysis, and population enrichment shall be integral parts of research protocols and trial design, and Offerors shall demonstrate expertise in these areas.
• Federal Interagency Traumatic Brain Injury Research (FITBIR) Data Sharing: See Section 5.3 of this RPP for details.
• Cost Share: The Government funds provided for this initiative are not anticipated to be the sole funding resource for the efforts. It is anticipated that the Government funds would provide incentive for non-DoD funding to join the project. While not a requirement, Offerors are strongly encouraged to include Cost Share as appropriate.
• Military Impact: This award must be relevant to the health care needs of the DoD. Offerors shall address the military need to better understand the impact of military-relevant, single and repeated mTBIs on brain health.
• Award Governance Structure: The successful Offeror(s) under this RPP will be managed by an appointed DoD program manager (PM). The successful Offeror(s) shall be prepared to communicate with the DoD PM on a routine basis for meetings in-person or virtually through video conferences or teleconferences to ensure continuing synchronization and integration of Awardee efforts and make recommendations for funding allocations based on progress of award Milestones and Deliverables. If other funding partners participate in cost sharing or co-funding, the DoD PM will make the final determination on the utilization of the DoD resources provided through this RPP.

Points of Contact

For inquiries, please direct your correspondence to Biomedical Research Associate Chuck Hutti, Ph.D. at Chuck.Hutti@ati.org.