Opportunity Information: Apply for W81XWH 22 S TBIPH1
The DoD Traumatic Brain Injury and Psychological Health, Clinical Trial Award (FY22 TBIPHRP CTA; Funding Opportunity Number W81XWH-22-S-TBIPH1) is a Department of Defense funding opportunity aimed at speeding up the launch and execution of human clinical trials that could meaningfully improve care for traumatic brain injury (TBI), psychological health conditions, or the overlap between the two. The main emphasis is on practical, clinically usable outcomes, such as healthcare products, devices, therapeutic approaches, technologies, and practice guidance that can realistically move into wider use. The mechanism is designed for studies that are ready to be implemented quickly and that have a clear path toward real-world impact, rather than early discovery or purely observational work.
This award specifically funds clinical trials, meaning studies where human participants are prospectively assigned to an intervention (which can include placebo or other controls) and outcomes are measured to see what effect the intervention has on biomedical or behavioral health endpoints. The scope of allowable interventions is broad and includes drugs and biologics, medical devices, therapies, clinical guidance, behavioral interventions, and emerging technologies, as well as testing new uses for products that are already FDA approved or cleared. Projects can range from small proof-of-concept efforts (such as pilot studies, first-in-human trials, or phase 0 work) up through larger trials intended to determine efficacy in relevant patient populations. At the same time, the opportunity draws a firm boundary around what it will not support: it cannot be used for animal studies, and it is not intended for clinical research that does not include an actual clinical trial. Applications where the primary purpose is comparative effectiveness research, implementation science, or health services research are directed to a different TBIPHRP mechanism (the Patient-Centered Research Award).
Several compliance and readiness expectations are central to this program. Trials are expected to start quickly, with the clinical trial beginning no later than 6 months after the award date, which effectively means applicants need to demonstrate that planning, logistics, staff, materials, and recruitment access are already well developed. Preliminary data relevant to the proposed clinical trial is required, and the trial must be grounded in a sound scientific rationale supported by a critical review of existing literature. Applications are also expected to show that the investigators have access to an appropriate patient population and a credible recruitment plan, including how accrual targets will be met and how standards of care could influence enrollment or outcomes. The program also expects applicants to document access to the intervention materials (drug/device/other), and to show that quality and stability are appropriate for the development stage, aligned with applicable FDA manufacturing and quality requirements (for example GMP or Quality System Regulation where relevant).
Regulatory expectations are a major part of the submission. If the trial tests a drug for an investigational use that is not FDA approved, an Investigational New Drug (IND) application under 21 CFR 312 may be required, and the applicant must include evidence either that an IND is not required (from the IRB or FDA) or that an IND has been submitted or authorized without a clinical hold. Similar requirements apply for devices: if an Investigational Device Exemption (IDE) under 21 CFR 812 is required, the application must include evidence of submission or authorization without clinical hold, or documentation that an IDE is not required or qualifies for an abbreviated IDE. If international sites are involved, the application must include evidence that relevant host-country regulatory submissions/approvals have been made. The announcement also notes that this funding opportunity cannot be used for studies that require an Exception From Informed Consent (EFIC), reinforcing that standard informed consent is expected.
The solicitation places strong emphasis on rigorous trial operations and accountability. Applications should present a clear trial design with well-defined objectives and endpoints, aligned with Good Clinical Practice (GCP). They must include a statistical analysis plan, statistical expertise on the team, and a power analysis that justifies sample size in relation to study objectives. Applicants must also include data management plans and appropriate database infrastructure; if the trial is FDA regulated, the database must be compliant with 21 CFR Part 11 and use appropriate data standards. Safety oversight is also required through a safety management plan (including pharmacovigilance when applicable) and a clinical monitoring plan explaining how the study will be monitored for GCP compliance. The program expects a dedicated study coordinator function to drive regulatory coordination (such as local IRB processes), multi-site coordination, and participant accrual management.
A distinctive requirement of this award is the mandatory use of Community-Based Participatory Research (CBPR) approaches in developing and executing the clinical trial. In practice, that means applicants need to show genuine, structured involvement of relevant communities and stakeholders (often including patients, caregivers, service members, veterans, clinicians, or community organizations, depending on the trial context) in shaping the study and ensuring it is feasible, acceptable, and responsive to real needs. The opportunity explicitly calls for CBPR documentation in specific application attachments, making this more than a general encouragement; it is a required element of the proposal.
The opportunity is structured into three research levels, with different budgets and timelines tied to trial stage and scale. Research Level 1 supports early, exploratory clinical trials such as proof-of-principle pilots, phase 0 or small phase 1 trials, and correlative studies tied to an intervention; it allows up to 3 years of performance and up to $500,000 in direct costs. Research Level 2 supports phase 1 and more advanced trials for promising interventions; it allows up to 4 years and up to $2 million in direct costs. Research Level 3 supports larger-scale trials intended to demonstrate efficacy in relevant patient populations; it also allows up to 4 years and up to $4 million in direct costs. Research Level 1 also offers an Early-Career Investigator Partnering Option that formally supports a two-PI structure (initiating and partnering PI) where one PI must qualify as an early-career investigator, with the combined direct costs still capped at $500,000; the application must make a clear case that the partnership is essential and that each PI brings distinct, necessary expertise.
The program also expects applicants to think beyond the end of the funded study. A required Transition Plan must explain how the intervention or product will move forward after the trial, whether that means progressing to the next clinical trial phase, pursuing regulatory steps, or moving toward commercialization or broader clinical adoption. Relatedly, applications should describe the planned product-label indication when appropriate and outline the product development plan needed to support that indication. Institutional commitment is emphasized as well, including (when applicable) a commitment to serve as the FDA regulatory sponsor and to fulfill sponsor responsibilities under 21 CFR 312 Subpart D.
On the transparency side, funded studies must be registered on ClinicalTrials.gov before the study starts. In addition, funded trials must post the IRB-approved informed consent form used to enroll participants on a publicly available federal website in alignment with 32 CFR 219 requirements. This is presented as a required condition of funding and reflects the broader federal push toward public accountability in human subjects research.
Administratively, this is a DoD opportunity administered by the Department of Defense, Department of the Army, USAMRAA, under CFDA 12.420, and it is listed as open to unrestricted applicant types (subject to any specific eligibility language in the full announcement). The funding instruments noted include cooperative agreements, grants, and procurement contracts, reflecting that the government may use different award structures depending on the specific project and management needs. The original closing date for FY22 submissions was December 8, 2022, with awards anticipated no later than September 30, 2023, and the opportunity projected up to 26 awards.Apply for W81XWH 22 S TBIPH1
- 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 Jul 15, 2022.
- Applicants must submit their applications by Dec 08, 2022. (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 26 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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FAQs: DoD Traumatic Brain Injury and Psychological Health, Clinical Trial Award (FY22 TBIPHRP CTA)
What is this funding opportunity?
The FY22 TBIPHRP Clinical Trial Award (Funding Opportunity Number W81XWH-22-S-TBIPH1) is a Department of Defense program intended to speed the launch and execution of human clinical trials that can meaningfully improve care for traumatic brain injury (TBI), psychological health conditions, or overlapping TBI and psychological health concerns.
What is the main focus of projects funded under this award?
The emphasis is on practical, clinically usable outcomes that can realistically move into broader use, such as healthcare products, devices, therapeutic approaches, technologies, and practice guidance. The mechanism is geared toward trials that are ready to implement quickly and have a clear path to real-world impact.
Does this award fund only clinical trials?
Yes. This award specifically supports clinical trials, defined here as studies in which human participants are prospectively assigned to an intervention (which can include placebo or other controls) and outcomes are measured to evaluate effects on biomedical and/or behavioral health endpoints.
What types of interventions can be tested?
The allowable intervention scope is broad and can include drugs and biologics, medical devices, therapies, clinical guidance, behavioral interventions, emerging technologies, and studies that test new uses for products that are already FDA approved or cleared.
What stages of clinical trials are supported?
Projects may range from small proof-of-concept efforts (such as pilot studies, first-in-human trials, or phase 0 work) through larger trials intended to determine efficacy in relevant patient populations.
What activities are explicitly not supported?
This opportunity cannot be used for animal studies and is not intended for clinical research that does not include an actual clinical trial.
Are comparative effectiveness, implementation science, or health services research projects allowed?
Applications where the primary purpose is comparative effectiveness research, implementation science, or health services research are directed to a different TBIPHRP mechanism (the Patient-Centered Research Award), not this Clinical Trial Award.
How quickly must the clinical trial begin after award?
The clinical trial is expected to begin no later than 6 months after the award date, so applicants are expected to be operationally ready (planning, logistics, staffing, materials, and recruitment access should be well developed).
Is preliminary data required?
Yes. Preliminary data relevant to the proposed clinical trial is required, and the trial must be supported by a sound scientific rationale and a critical review of existing literature.
What does the program expect regarding access to participants and recruitment?
Applicants are expected to demonstrate access to an appropriate patient population and provide a credible recruitment plan, including how accrual targets will be met and how standards of care could affect enrollment or outcomes.
Do applicants need to document access to the intervention materials?
Yes. Applications are expected to document access to the intervention materials (drug, device, or other), and to show that quality and stability are appropriate for the development stage and aligned with applicable FDA manufacturing and quality requirements (for example GMP or Quality System Regulation where relevant).
When is an IND required, and what evidence must be provided?
If the trial tests a drug for an investigational use that is not FDA approved, an Investigational New Drug (IND) application under 21 CFR 312 may be required. The application must include evidence that an IND is not required (from the IRB or FDA) or evidence that an IND has been submitted or authorized without a clinical hold.
When is an IDE required, and what evidence must be provided?
If the trial involves a device that requires an Investigational Device Exemption (IDE) under 21 CFR 812, the application must include evidence of submission or authorization without clinical hold, or documentation that an IDE is not required or qualifies for an abbreviated IDE.
What if the trial includes international sites?
If international sites are involved, the application must include evidence that relevant host-country regulatory submissions and/or approvals have been made.
Are trials that require an Exception From Informed Consent (EFIC) allowed?
No. The announcement states the opportunity cannot be used for studies that require an Exception From Informed Consent (EFIC), indicating standard informed consent is expected.
What trial design and quality standards are expected?
Applications should present a clear trial design with well-defined objectives and endpoints aligned with Good Clinical Practice (GCP). The program emphasizes rigorous trial operations and accountability.
What statistical elements must be included?
Applications must include a statistical analysis plan, statistical expertise on the team, and a power analysis that justifies the sample size relative to the study objectives.
What data management and database requirements apply?
Applicants must include data management plans and appropriate database infrastructure. If the trial is FDA regulated, the database must be compliant with 21 CFR Part 11 and use appropriate data standards.
What safety oversight and monitoring plans are required?
A safety management plan is required (including pharmacovigilance when applicable), along with a clinical monitoring plan describing how the study will be monitored for GCP compliance.
Is a study coordinator required?
The program expects a dedicated study coordinator function to support regulatory coordination (such as local IRB processes), multi-site coordination, and participant accrual management.
Is Community-Based Participatory Research (CBPR) required?
Yes. A distinctive feature of this award is the mandatory use of Community-Based Participatory Research (CBPR) approaches in developing and executing the clinical trial, with required CBPR documentation in specific application attachments.
What does CBPR mean in the context of this award?
CBPR means genuine, structured involvement of relevant communities and stakeholders (which may include patients, caregivers, service members, veterans, clinicians, or community organizations depending on the trial) to help shape the study and improve feasibility, acceptability, and responsiveness to real needs.
What are the research levels and funding limits?
The opportunity includes three research levels tied to trial stage/scale: Level 1 (up to 3 years and up to $500,000 in direct costs), Level 2 (up to 4 years and up to $2 million in direct costs), and Level 3 (up to 4 years and up to $4 million in direct costs).
What kinds of studies fit Research Level 1?
Research Level 1 supports early, exploratory clinical trials such as proof-of-principle pilots, phase 0 or small phase 1 trials, and correlative studies tied to an intervention.
What kinds of studies fit Research Level 2?
Research Level 2 supports phase 1 and more advanced trials for promising interventions, with a larger budget and up to 4 years of performance.
What kinds of studies fit Research Level 3?
Research Level 3 supports larger-scale trials intended to demonstrate efficacy in relevant patient populations, with up to $4 million in direct costs over up to 4 years.
What is the Early-Career Investigator Partnering Option?
At Research Level 1, an Early-Career Investigator Partnering Option allows a formal two-PI structure (initiating and partnering PI) where one PI must qualify as an early-career investigator. The combined direct costs remain capped at $500,000, and the application must explain why the partnership is essential and how each PI provides distinct, necessary expertise.
Is a Transition Plan required?
Yes. A required Transition Plan must explain how the intervention or product will move forward after the trial (for example, progression to the next clinical trial phase, regulatory steps, commercialization, or broader clinical adoption).
Do applicants need to describe a planned product-label indication and product development plan?
Yes, when appropriate. Applications should describe the planned product-label indication and outline the product development plan needed to support that indication.
What is expected regarding institutional commitment and FDA regulatory sponsorship?
Institutional commitment is emphasized, including (when applicable) a commitment to serve as the FDA regulatory sponsor and to fulfill sponsor responsibilities under 21 CFR 312 Subpart D.
Are there public registration and transparency requirements?
Yes. Funded studies must be registered on ClinicalTrials.gov before the study starts.
Are there requirements to post the informed consent form publicly?
Yes. Funded trials must post the IRB-approved informed consent form used to enroll participants on a publicly available federal website, consistent with 32 CFR 219 requirements.
Which agency administers this opportunity?
This is a DoD opportunity administered by the Department of Defense, Department of the Army, USAMRAA, under CFDA 12.420.
Who is eligible to apply?
The opportunity is listed as open to unrestricted applicant types, subject to any specific eligibility language in the full announcement.
What funding instruments might be used?
The funding instruments noted include cooperative agreements, grants, and procurement contracts, indicating the government may use different award structures depending on project needs and management approach.
What was the FY22 submission deadline and anticipated award timing?
The original closing date for FY22 submissions was December 8, 2022. Awards were anticipated no later than September 30, 2023.
How many awards were projected?
The opportunity projected up to 26 awards.
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