DoD Traumatic Brain Injury and Psychological Health, Clinical Research Development Award | W81XWH 21 TBIPHRP CRDA

Opportunity Information: Apply for W81XWH 21 TBIPHRP CRDA

The FY21 DoD Traumatic Brain Injury and Psychological Health (TBIPHRP) Clinical Research Development Award (CRDA) is a planning-focused funding opportunity designed to help teams get fully prepared to launch a future clinical study that could meaningfully improve care or outcomes related to traumatic brain injury (TBI) and/or psychological health. The central idea is that the CRDA pays for the practical, nuts-and-bolts work needed to start a high-impact clinical research project or clinical trial later, rather than paying for the clinical study itself during the CRDA performance period. By the end of the award, recipients are expected to have a well-developed, actionable plan that positions them to apply for a larger, later-stage TBIPHRP award in the next program cycle (noting that future opportunities depend on appropriations and competition, and this award does not guarantee follow-on funding).

A key rule is that the CRDA period cannot be used to conduct prospectively enrolled human subjects clinical research or clinical trials. The announcement is explicit that applications proposing clinical research or a clinical trial during the CRDA period of performance risk administrative withdrawal. In this context, a clinical trial means a prospective assignment of human subjects to one or more interventions (including placebo or controls) to evaluate effects on biomedical or behavioral health outcomes. The opportunity also clarifies what counts as clinical research under the CDMRP definition, including patient-oriented research involving direct interaction with prospectively enrolled human subjects, epidemiologic and behavioral studies, outcomes research, and health services research. It also draws an important boundary: studies that qualify for IRB Exemption 4 (for example, research using existing, de-identified specimens or publicly available de-identified data) are not considered CDMRP-defined clinical research, which matters for determining whether a proposed activity is allowable during the planning award.

Although the award is not meant to fund preclinical or clinical studies whose main purpose is to generate preliminary data or proof-of-principle, preliminary data are still required as part of the application. In other words, applicants need to come in with a foundation that justifies the planned future clinical study. There is one notable exception where limited preclinical work may be supported: if the FDA requires specific preclinical data as a condition to begin a future clinical study, the CRDA can support generating that FDA-requested preclinical data. If an applicant proposes that type of work, they are expected to include evidence of communication with the FDA in the supporting documentation. The announcement allows the use of animals and human anatomical substances or data, but maintains the prohibition on prospectively enrolling human subjects for clinical research/trials during the CRDA timeframe.

The CRDA is flexible in the types of planning and development tasks it will support, and the announcement provides a concrete menu of examples. These include preparing for regulatory approvals (such as IRB submissions and FDA submissions like IND or IDE applications), assembling the research team and initiating collaborations (including partnerships with community-based organizations and lived-experience consultants), developing the research plan and statistical approach, drafting the clinical protocol, ensuring access to appropriate patient populations or other resources, creating training procedures, anticipating intellectual property or materials issues, and building a transition plan to move efficiently into the next phase of research (including engaging industry partners when appropriate). The opportunity also emphasizes data stewardship and interoperability by encouraging applicants to cross-map data elements to TBI and/or psychological health common data elements (CDEs), and it suggests applicants review the FY21 TBIPHRP Clinical Trial Award requirements so that the CRDA planning period is tightly aligned with what will be needed for a later clinical trial submission.

The announcement also explicitly welcomes planning work tied to implementation research, framing it as the scientific study of strategies to adopt and integrate evidence-based interventions into clinical and community settings to improve outcomes and population health. This includes planning efforts that identify barriers to adoption, adaptation, integration, scale-up, and sustainability of evidence-based tools, policies, or guidelines. It also highlights the value of "de-implementation" planning, meaning efforts to understand when and how to reduce or stop the use of interventions that are ineffective, unproven, low-value, or harmful. Methodological advances in dissemination and implementation research are encouraged as well, as long as the work remains within the planning-and-development scope required by this mechanism.

Military health relevance is treated as a core feature rather than an optional add-on. Applicants are expected to explain how the planned future study addresses TBI and/or psychological health in ways that matter for Service Members, Veterans, military beneficiaries, and, by extension, the American public. Examples of strong relevance include a clear link to health and readiness needs, a dual-use rationale showing how the outputs could benefit both military and civilian settings, appropriate use of military or Veteran populations/samples/datasets, and collaboration with Department of Defense or Department of Veterans Affairs investigators or consultants. The program encourages teams to align with or integrate into DoD and/or VA research programs and labs, and points applicants to resources (via an appendix) for finding potential collaboration opportunities.

From an administrative and funding standpoint, awards are made as assistance agreements, meaning they take the form of either a grant or a cooperative agreement depending on how much substantial involvement the DoD anticipates having during project performance. If the agency does not expect substantial involvement, the award is typically a grant; if substantial involvement is expected (for example, collaboration, participation, or intervention in the work), it is structured as a cooperative agreement, with the specific involvement outlined in the award terms. The total budget for the entire period of performance is capped at $300,000 in total costs. Programmatically, the DoD anticipated allocating roughly $3 million to fund about 10 awards under this announcement, with actual funding dependent on appropriations, the number and quality of applications, and program priorities. The opportunity was created on August 6, 2021, had an original closing date of September 30, 2021, and anticipated making awards no later than September 30, 2022. Eligible applicants are listed as unrestricted (open to any entity type, subject to any specific eligibility clarifications in the full announcement). The administering agency is the Department of Defense, Department of the Army, USAMRAA, and the CFDA listing is 12.420.

Finally, the announcement points applicants to other TBIPHRP mechanisms when the proposed work does not fit a planning-only development award. Teams that want to run a clinical trial during the award period are directed instead to the FY21 TBIPHRP Clinical Trial Award (W81XWH-21-S-TBIPH1). Applicants pursuing other research directions may be better suited to the Idea Development Award, Investigator-Initiated Research Award, or Translational Research Award mechanisms listed in the opportunity. The CRDA is best understood as a structured on-ramp: it funds the preparatory work needed to responsibly and competitively launch a future clinical study that could move the needle on TBI and psychological health, especially in military and Veteran-relevant contexts.

• 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 Research Development 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 Aug 06, 2021.
• Applicants must submit their applications by Sep 30, 2021. (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 10 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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