Opportunity Information: Apply for W81XWH 19 ARP CTRA

The Department of Defense Autism Research Program (ARP) Clinical Translational Research Award (CTRA) is a funding opportunity designed to move promising autism spectrum disorder (ASD) interventions closer to real-world clinical impact. It specifically targets early-phase, proof-of-principle translational research that is hypothesis-driven and tests innovative interventions with the potential to address current clinical deficits in ASD. The intent is not to fund large, definitive clinical trials at this stage, but rather to generate credible early human evidence that an intervention is feasible, biologically or clinically meaningful, and worthy of larger efficacy-based trials later on. In other words, the program is aiming to build the scientific rationale and early data foundation that can justify subsequent, more expensive and more conclusive clinical testing that could ultimately change standard clinical care for individuals with ASD.

Applicants are strongly encouraged to align proposed projects with the program's stated Areas of Interest for the relevant fiscal year (FY19). If a proposal does not fit within those listed priority topics, it is still potentially eligible, but the application is expected to make a clear case for why the work addresses a critical unmet need for the ASD community. This emphasis signals that relevance and potential impact on pressing clinical challenges are central review considerations, alongside scientific quality and innovation. The award is positioned to support translational efforts that connect mechanistic or conceptual advances to tangible intervention strategies, with an expectation that funded projects will produce actionable results rather than purely exploratory findings.

A defining feature of this award is that projects are required to involve human subjects. The supported research must be early-phase and proof-of-principle in nature, and it may include interventional designs such as Phase 0 clinical trials or single-group intervention studies. Limited retrospective analysis can be included when it meaningfully supports the translational objectives, but proposals that are purely retrospective or focused only on database mining are not allowed. Likewise, projects that are strictly animal research, or that focus on developing/refining new technology in animals, are not permissible under this funding opportunity. The announcement also excludes research aimed at establishing the efficacy or effectiveness of diagnostic agents, indicating the program is focused on interventions and clinical deficits rather than diagnostic product validation.

Administratively, the opportunity was issued by the Department of Defense, Department of the Army, through the U.S. Army Medical Research Acquisition Activity (USAMRAA). It was offered under Funding Opportunity Number W81XWH-19-ARP-CTRA, categorized as a discretionary science and technology/research and development program (CFDA 12.420). The funding instrument could be either a grant or a cooperative agreement, meaning awards may range from more investigator-driven projects (grants) to projects with more substantial government involvement or coordination (cooperative agreements), depending on the needs of the selected work. Eligibility was listed as unrestricted, open to any applicant type as permitted by any additional eligibility notes in the full announcement. The opportunity anticipated making a small number of awards (expected awards: 2). The posting date was March 18, 2019, with an original closing date of August 8, 2019. The award ceiling was listed as 0 in the summarized data, which typically indicates that the maximum funding level was not captured in that specific listing and would need to be confirmed in the full program announcement or associated budget guidance.

Overall, this grant opportunity is best understood as a targeted push to accelerate credible, early human testing of innovative ASD interventions that can address meaningful clinical problems. The program draws a clear boundary around what it will and will not support: it prioritizes translational intervention studies in humans, discourages purely retrospective/database work, and excludes animal-only research and diagnostic agent efficacy testing. The expected end product is early clinical evidence that can justify and shape later-stage, larger clinical trials aimed at improving outcomes and transforming ASD clinical care.

  • 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 Autism Clinical Translational Research 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 Mar 18, 2019.
  • Applicants must submit their applications by Aug 08, 2019. (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 2 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.
Apply for W81XWH 19 ARP CTRA

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FAQs: DoD Autism Research Program (ARP) Clinical Translational Research Award (CTRA)

What is the ARP Clinical Translational Research Award (CTRA)?

The Department of Defense Autism Research Program (ARP) Clinical Translational Research Award (CTRA) is a funding opportunity intended to move promising autism spectrum disorder (ASD) interventions closer to real-world clinical impact by supporting early-phase, proof-of-principle translational research in humans.

What is the main goal of this award?

The goal is to generate credible early human evidence that an innovative ASD intervention is feasible, biologically or clinically meaningful, and strong enough to justify larger, later-stage efficacy-based trials that could eventually influence standard clinical care.

Is this award meant to fund large, definitive clinical trials?

No. The intent is explicitly not to fund large, definitive clinical trials at this stage. Instead, it supports earlier translational steps that build the scientific rationale and data foundation needed to support later, more expensive and conclusive trials.

What kind of research is considered a good fit (in general)?

A strong fit is hypothesis-driven, early-phase translational research that tests innovative interventions intended to address current clinical deficits in ASD, with an emphasis on producing actionable results rather than purely exploratory findings.

Are human subjects required?

Yes. Projects funded under this opportunity are required to involve human subjects.

What types of study designs are allowed?

The opportunity allows early-phase, proof-of-principle interventional designs, including examples such as Phase 0 clinical trials or single-group intervention studies.

Can retrospective analysis be included?

Limited retrospective analysis may be included only when it meaningfully supports the translational objectives of the proposed work.

Are purely retrospective or database-mining projects allowed?

No. Proposals that are purely retrospective or focused only on database mining are not permitted under this funding opportunity.

Is animal-only research eligible?

No. Projects that are strictly animal research are not permissible under this award.

Can applicants propose developing or refining new technology in animals?

No. Research focused on developing or refining new technology in animals is excluded under this funding opportunity.

Does the award support research focused on diagnostic agents?

The announcement excludes research aimed at establishing the efficacy or effectiveness of diagnostic agents, indicating the program is focused on interventions and clinical deficits rather than diagnostic product validation.

Does the program require alignment with specific Areas of Interest?

Applicants are strongly encouraged to align projects with the program's stated Areas of Interest for the relevant fiscal year (FY19).

What if a proposal does not fit the FY19 Areas of Interest?

A proposal may still be potentially eligible, but the application is expected to clearly explain why the work addresses a critical unmet need for the ASD community.

What does the program emphasize in addition to scientific quality?

Based on the description provided, relevance to pressing clinical challenges for the ASD community and potential for meaningful clinical impact are central considerations alongside scientific quality and innovation.

Who issued this funding opportunity?

The opportunity was issued by the Department of Defense, Department of the Army, through the U.S. Army Medical Research Acquisition Activity (USAMRAA).

What is the Funding Opportunity Number (FON)?

The Funding Opportunity Number is W81XWH-19-ARP-CTRA.

What CFDA number is associated with this program?

The opportunity is categorized under CFDA 12.420.

What type of funding instrument is used?

The funding instrument could be either a grant or a cooperative agreement.

What is the difference between a grant and a cooperative agreement for this opportunity?

As described, a grant generally indicates a more investigator-driven project, while a cooperative agreement may involve more substantial government involvement or coordination, depending on the needs of the selected work.

Who is eligible to apply?

Eligibility was listed as unrestricted, meaning it was open to any applicant type as permitted by any additional eligibility notes in the full announcement.

How many awards were expected to be made?

The opportunity anticipated making a small number of awards, with expected awards listed as 2.

When was the opportunity posted?

The posting date was March 18, 2019.

What was the closing date for applications?

The original closing date was August 8, 2019.

What is the maximum award amount (ceiling)?

The award ceiling was listed as 0 in the summarized data. This typically indicates the maximum funding level was not captured in that specific listing and would need to be confirmed in the full program announcement or related budget guidance.

What is the overall focus of the CTRA within autism research?

Overall, it is a targeted effort to accelerate credible, early human testing of innovative ASD interventions that address meaningful clinical problems, with the expected outcome being early clinical evidence that can shape and justify later-stage larger clinical trials.

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