DoD Traumatic Brain Injury and Psychological Health, Clinical Trial Award | W81XWH 21 S TBIPH1

FY21 DoD TBI and Psychological Health Clinical Trial Award (CTA) - FAQs

1) What is the FY21 DoD Traumatic Brain Injury and Psychological Health Clinical Trial Award (CTA)?

The FY21 DoD TBI and Psychological Health Clinical Trial Award (CTA) is a Department of Defense funding opportunity administered through CDMRP and USAMRDC/USAMRAA to rapidly launch human clinical trials aimed at meaningfully improving care for traumatic brain injury (TBI) and/or psychological health conditions.

2) What is the main goal of this award?

The core goal is impact and speed: support clinical trials that are ready to start quickly and produce results that can drive next-step development, adoption into real-world use, and/or regulatory progress.

3) What types of interventions are in scope?

The CTA is intended to generate evidence to move an intervention toward real-world clinical application. The intervention may be a healthcare product, technology, therapy, drug/biologic, medical device, clinical guidance, an emerging approach, or a new use for something already FDA-approved or FDA-cleared.

4) Does this award fund general clinical research, or only clinical trials?

This mechanism is strictly for clinical trials. Proposals that are clinical research without a clinical trial do not fit the intent and will not be funded under this award.

5) How does this program define a clinical trial?

Under this program, a clinical trial is a study in which human participants are prospectively assigned to one or more interventions (including placebo or control) to evaluate the effects on biomedical or behavioral outcomes.

6) Are observational studies allowed?

No. Observational patient-oriented studies that do not prospectively assign an intervention are described as not fitting the intent of this award.

7) Are comparative effectiveness, implementation science, or health services research allowed?

No. Projects where the main goal is clinical care translation research (including comparative effectiveness research, implementation science, or healthcare services research) are explicitly not allowed under the CTA and are directed to the separate Translational Research Award opportunity.

8) Are animal studies allowed?

No. Animal studies are not allowable because the funding must directly support a human clinical trial.

9) Can the CTA support studies that require an Exception From Informed Consent (EFIC)?

No. This announcement cannot be used for studies that require an Exception From Informed Consent (EFIC).

10) What are the Research Levels, and how do they differ?

The CTA supports three research levels covering a range of trial maturities:

• Research Level 1: Proof-of-principle and exploratory efforts (pilot studies, phase 0 or small phase 1 trials, and correlative studies tied to an intervention).
• Research Level 2: Phase 1 and more advanced trials for promising interventions.
• Research Level 3: Larger-scale trials designed to demonstrate efficacy in relevant patient populations.

11) What is the maximum period of performance and budget for Research Level 1?

Research Level 1 awards run up to 3 years with budgets up to $750,000 in total costs.

12) What is the maximum period of performance and budget for Research Level 2?

Research Level 2 awards run up to 4 years with budgets up to $3 million.

13) What is the maximum period of performance and budget for Research Level 3?

Research Level 3 awards run up to 4 years with budgets up to $6 million.

14) Who chooses the Research Level for an application?

Applicants are responsible for choosing the appropriate level based on what they are proposing and how mature the intervention and evidence base are.

15) What is the Early-Career Investigator Partnering Option?

It is an option intended to encourage team science and help develop the next generation of investigators, structured around two principal investigators (PIs): an Initiating PI and a Partnering PI.

16) Which Research Level(s) can use the Early-Career Investigator Partnering Option?

This option is available only for Research Level 1.

17) In the partnering option, who can be the early-career investigator?

Either PI (the Initiating PI or the Partnering PI) may be the early-career investigator.

18) What does the application need to show to justify the partnering option?

The application must make a convincing case that the partnership is essential, that each PI brings distinct and necessary expertise, and that the joint effort is stronger than two separate projects.

19) If funded under the partnering option, how are the PIs recognized?

Each PI is named on an individual award within the recipient organization.

20) How quickly are trials expected to begin after an award is made?

Trials are expected to begin within 6 months of the award date, or within 9 months for FDA-regulated studies.

21) Is preliminary data required?

Yes. Preliminary data relevant to the proposed trial is required.

22) What kind of scientific rationale is expected?

The trial must be built on a sound scientific rationale grounded in critical evaluation of the literature.

23) What are the expectations regarding patient access and recruitment?

Applications should demonstrate access to an appropriate patient population and provide a realistic accrual plan, including how standards of care might affect recruitment or eligibility.

24) Do applicants need to show access to the intervention materials?

Yes. Applicants are expected to document access to the intervention materials (drug, device, or other required supplies) for the full study duration.

25) Are there expectations related to product quality, manufacturing, and stability?

Yes. Applicants should address product quality and stability consistent with applicable FDA manufacturing expectations (for example, GMP or Quality System Regulation standards), depending on product type and development stage.

26) What IND requirements apply to drug studies?

If the study uses a drug not approved by the FDA for the intended investigational use, an IND under 21 CFR 312 may be required. Applicants must provide evidence from the IRB or FDA if an IND is not required.

27) If an IND is required, what does the program expect by the proposal submission deadline?

The program expects an IND without partial or complete clinical hold status to already be in place by the proposal submission deadline, and the IND must match the specific product and indication being tested.

28) What IDE requirements apply to device studies?

Device studies may require an IDE under 21 CFR 812. If required, an IDE without hold status must be in place by the submission deadline and must align with the device and indication proposed (not a modified or derivative version).

29) What is required for trials conducted at international sites?

The application must include evidence that submissions to the relevant host-country regulatory agencies have been filed by the submission deadline.

30) What clinical trial quality standards are expected?

Applications are expected to reflect Good Clinical Practice (GCP) and include clear objectives, well-justified endpoints and outcome measures, and a detailed statistical analysis plan supported by appropriate statistical expertise.

31) Are power calculations and sample size justification required?

Yes. A power analysis and sample size justification are expected so reviewers can assess whether the study can answer its primary question.

32) What data management expectations are described?

Applicants should include a data management plan and appropriate database selection. For FDA-regulated studies, the program expects a 21 CFR 11-compliant database with suitable data standards.

33) Are safety oversight and monitoring plans required?

Yes. Proposals should include a safety management plan describing pharmacovigilance or other safety monitoring, plus a clinical monitoring plan showing how protocol adherence and GCP compliance will be ensured.

34) Is study coordination capacity expected?

Yes. The program expects dedicated study coordination capacity to manage IRB and regulatory workflows, oversee multi-site coordination, and support participant recruitment and retention.

35) What is a Transition Plan, and is it required?

A Transition Plan is required and should describe how the product or intervention will advance after the award, such as progressing to the next trial phase, moving toward regulatory submission, scaling deployment, pursuing commercialization, or broader implementation.

36) If relevant, what product/label information should be addressed?

When relevant, applicants should describe the planned product label indication and outline a development plan that would support that indication.

37) What does the announcement say about institutional support and FDA sponsor responsibilities?

The announcement emphasizes institutional support, including (when applicable) a commitment to act as the FDA regulatory sponsor and fulfill sponsor responsibilities under the relevant FDA regulations.

38) Are there ClinicalTrials.gov requirements?

Yes. Funded trials must register on ClinicalTrials.gov before starting.

39) Are there requirements to publicly post the informed consent form?

Yes. Funded trials must post a copy of the IRB-approved informed consent form used for enrollment on a publicly available federal website, consistent with requirements under 32 CFR 219.

40) How important is military relevance for this opportunity?

Military relevance is a central evaluation theme. Projects should clearly explain how they address TBI and/or psychological health in ways that matter to Service Members, Veterans, military beneficiaries, and the broader public.

41) What kinds of collaborations are encouraged?

The program encourages partnerships between military/Veteran institutions and civilian organizations, including collaboration with DoD or VA investigators, consultants, programs, or laboratories when relevant.

42) What is the CFDA number and what type of opportunity is this?

This is a discretionary opportunity listed as CFDA 12.420.

43) What award instruments may be used?

Awards may be made as either grants or cooperative agreements, depending on the anticipated level of government involvement during execution.

44) How much total funding was expected for FY21, and how many awards were anticipated?

The FY21 funding pool was expected to be about $58.5 million, supporting roughly 28 awards total, subject to federal funding availability and the quality and merit of applications.

45) How were awards approximately distributed across Research Levels?

The opportunity anticipated approximately 14 awards at Level 1, 12 at Level 2, and 2 at Level 3 (subject to change based on funding availability and application merit).

46) When was this opportunity posted and when did it close?

The opportunity was posted on August 6, 2021, with an original closing date of December 16, 2021.

47) When were awards anticipated?

Awards were anticipated no later than September 30, 2022.

48) How long are FY21 funds expected to remain available for obligation?

Funding is tied to FY21 appropriations and was expected to remain available for obligation within the government's allowable time window, with FY21 funds expiring for use on September 30, 2027.