DoD Traumatic Brain Injury and Psychological Health, Clinical Trial Award | HT9425 23 S TBIPH1

Opportunity Information: Apply for HT9425 23 S TBIPH1

The DoD Traumatic Brain Injury and Psychological Health, Clinical Trial Award (FY23 TBIPHRP CTA) is designed to move quickly from promising ideas to real-world testing by funding clinical trials that could meaningfully improve outcomes for traumatic brain injury (TBI), psychological health conditions, or the overlap between the two. The core purpose is rapid implementation of clinical trials that lead to practical, usable clinical applications, such as new or improved health care products, technologies, therapies, behavioral interventions, diagnostics, devices, or practice guidelines. Projects can range from small early studies that establish feasibility (like pilot studies, first-in-human work, or phase 0 trials) to larger trials aimed at determining efficacy in patient populations where the results could influence care decisions.

A key point is that this mechanism only funds true clinical trials. In this context, a clinical trial means human participants are prospectively assigned to one or more interventions (which can include placebo or another control) specifically to evaluate effects on biomedical or behavioral health outcomes. Studies that do not measure safety, effectiveness, or efficacy outcomes for an intervention do not qualify. The opportunity is not meant for preclinical work, and applicants whose main objective is comparative effectiveness, implementation science, or health care services research are steered toward a different TBIPHRP funding mechanism (the Health Services Research Award) rather than this one.

The award supports evaluation of a wide range of interventions. This includes drugs or biologics, devices, diagnostics, therapies, clinical guidance, behavioral interventions, and emerging technologies, as well as new uses for products that are already FDA-approved or FDA-cleared. Interventions that are not regulated by the FDA (or an international equivalent) are still allowed, but the applicant must clearly document regulatory status and plans in a required Regulatory Strategy attachment. For studies involving investigational drugs or devices that are not approved for the intended use, the program emphasizes regulatory readiness: an IND (for drugs/biologics) or IDE (for devices), or an applicable international equivalent, may be required. If an IND/IDE is not required, the applicant must provide evidence from the IRB of record or the relevant regulatory agency. If it is required, the application must include proof that the submission has been cleared/authorized and is not on clinical hold. The program also expects the trial to use the specific product or device as described in the regulatory submission, not a modified or derivative version, and international site trials must show host-country regulatory submissions/approvals as part of the regulatory strategy.

Several practical readiness expectations are built into the solicitation. For regulated studies, the clinical trial is expected to start within six months of the award date, so applicants need to be positioned to launch quickly. Preliminary data relevant to the proposed trial are required, reinforcing that the program is looking for interventions with enough support to justify near-term human testing. Applications must also show that an appropriate study population is available and accessible, including a realistic recruitment and accrual plan and an inclusion strategy for women and minorities that matches the study objectives (with limited exemptions for certain de-identified biospecimen or dataset studies that cannot be linked to individual demographics). Applicants must also document that the intervention materials (drug, device, compounds, or other required resources) will be available for the full duration of the trial.

The program strongly emphasizes execution capability and community engagement. Applicants need to show the team has proven clinical trial expertise, including statistics, data management, and familiarity with regulatory processes when applicable. The solicitation calls for a study coordinator role that can shepherd the protocol through local IRB review and other federal regulatory approvals, coordinate multi-site activities if relevant, and support participant recruitment. Institutional commitment matters as well, particularly when the institution will serve as the regulatory sponsor for FDA-regulated studies and must take on sponsor responsibilities under federal regulations (for example, 21 CFR 312 for drugs/biologics). In addition, the application must include Community-Based Participatory Research (CBPR) approaches, meaning community or stakeholder partners are expected to be meaningfully involved in shaping and carrying out the trial, with specific CBPR documentation required in designated attachments.

From a design and analysis standpoint, the DoD encourages thoughtful, efficient trial designs when they fit the question, including innovative models such as Bayesian or adaptive designs, seamless approaches, stepped-wedge designs, basket trials, and other methods intended to improve efficiency while maintaining scientific integrity and ethical safeguards. Precision medicine approaches are also encouraged when appropriate, with the idea of tailoring interventions based on individual characteristics to deliver the right treatment at the right time. Each application must include a clear statistical analysis plan, a power analysis that justifies the sample size needed to answer the main objectives, and a data management plan that protects data integrity. When required by a regulatory agency, the trial database must be compliant with 21 CFR Part 11 and use appropriate data standards.

There are also specific transparency and compliance obligations for funded trials. Awardees must register the study on ClinicalTrials.gov prior to starting the trial, and they must post a copy of the informed consent form on a publicly available federal website in line with federal human subjects requirements. The solicitation also notes that this funding opportunity cannot be used for studies requiring an exception from informed consent (EFIC), which effectively narrows the scope away from emergency research designs that would rely on EFIC provisions.

Funding is structured across three research levels based on trial stage and scale. Research Level 1 supports early, exploratory clinical trials (including proof-of-principle pilot studies and phase 0/small phase 1 work) with up to three years of performance and up to $500,000 in direct costs. Level 1 also includes an Early-Career Investigator Partnering Option that allows two PIs (one early-career) to collaborate under a shared $500,000 direct cost cap, with clear expectations that both investigators contribute meaningfully and bring distinct expertise. Research Level 2 supports phase 1 and more advanced trials for promising interventions, allowing up to four years and up to $2.0 million in direct costs. Research Level 3 supports larger-scale trials intended to demonstrate efficacy in relevant patient populations, also up to four years, with up to $4.0 million in direct costs. The opportunity is offered by the Department of Defense (USAMRAA) as discretionary funding using grants and cooperative agreements, is broadly open to eligible applicant types per the solicitation, and anticipated awards were to be made no later than September 30, 2024.

• The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Traumatic Brain Injury and Psychological Health, Clinical Trial Award" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
• This funding opportunity was created on Apr 27, 2023.
• Applicants must submit their applications by Sep 28, 2023. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 29 candidate(s).
• Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.

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