Opportunity Information: Apply for HT9425 23 ARP CTA
The Department of Defense Autism Research Program (ARP) Clinical Trial Award is a discretionary funding opportunity run through the U.S. Army Medical Research Acquisition Activity (USAMRAA) that is meant to move autism spectrum disorder (ASD) research quickly into real-world testing. The purpose is straightforward: fund the rapid launch and execution of clinical trials that have a strong chance of making a meaningful difference in how ASD is treated or managed. In practice, this means the program is not looking for early laboratory or animal work, but for studies that are ready to be tested in people and that could change clinical or community-based care if the results are positive.
A central feature of the opportunity is its emphasis on alignment with the fiscal year 2023 ARP Clinical Trial Award Areas of Interest. Applicants are strongly encouraged to design their proposed clinical trial around one of these priority topics. If a proposal does not clearly fit an Area of Interest, the application must make a convincing case that the study still tackles an important and significant problem affecting individuals with ASD. This requirement signals that the program is prioritizing focus and relevance, and it expects applicants to show why their trial matters now and how it could improve outcomes for autistic individuals or address unmet needs in care.
The award supports a wide range of clinical trial types, as long as they are genuinely clinical trials and are aimed at treatment or management. Trials can test promising new products, pharmacologic agents such as drugs or biologics, behavioral interventions, medical or assistive devices, clinical guidance approaches, and emerging methods or technologies that could shift practice. The underlying theme is impact: the program is oriented toward interventions or strategies that could be implemented and that would matter for patients, families, clinicians, and systems of care. At the same time, the funding is not meant for preclinical research, so projects that are primarily exploratory, mechanistic, or limited to lab development without a human trial component would not fit this mechanism.
Administratively, the opportunity is listed under Funding Opportunity Number HT9425 23 ARP CTA and falls within the Science and Technology and other Research and Development activity category (CFDA 12.420). The funding can be made through either a grant or a cooperative agreement, indicating that some projects may involve more active involvement or coordination with the funding agency depending on award structure. Eligibility is described as unrestricted, meaning the competition is broadly open to many entity types, though applicants are still expected to review any clarifications in the full opportunity text. The posting date is March 3, 2023, with an original closing date of July 20, 2023. The notice indicates an expectation of about two awards, and the award ceiling is listed as 0, which typically means the ceiling was not specified in the summary field rather than that no funding is available.
Overall, this opportunity is best viewed as a targeted clinical trials program for ASD that is designed to accelerate the testing of interventions with practical potential. It rewards readiness to run a clinical trial, clear alignment with program priorities (or a well-justified alternative), and a credible pathway to improving treatment or management for people with ASD, while explicitly excluding preclinical work from being supported under this award mechanism.Apply for HT9425 23 ARP CTA
- 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 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 Mar 03, 2023.
- Applicants must submit their applications by Jul 20, 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 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.
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FAQs: DoD Autism Research Program (ARP) Clinical Trial Award
What is this funding opportunity?
This is the Department of Defense Autism Research Program (ARP) Clinical Trial Award, a discretionary funding opportunity administered through the U.S. Army Medical Research Acquisition Activity (USAMRAA). It is designed to support the rapid launch and execution of clinical trials in autism spectrum disorder (ASD).
What is the main purpose of the ARP Clinical Trial Award?
The purpose is to move ASD research quickly into real-world testing by funding clinical trials that are ready to be conducted in people and that have a strong chance of meaningfully improving how ASD is treated or managed if results are positive.
What kinds of studies is the program trying to accelerate?
The program emphasizes studies that can be implemented in clinical or community-based settings and that could change practice. The focus is on readiness and impact rather than early-stage discovery.
Does this award support preclinical research (lab studies or animal studies)?
No. The opportunity is explicitly oriented toward human clinical trials and is not intended for preclinical research. Projects that are primarily exploratory, mechanistic, or limited to laboratory development without a human trial component would not fit this mechanism.
What types of clinical trials are supported?
A wide range of genuine clinical trial types are supported as long as they focus on treatment or management of ASD. The opportunity highlights trials that can test interventions or strategies with practical potential to improve outcomes or address unmet needs in care.
What kinds of interventions can be tested under this award?
The award supports clinical trials evaluating, for example:
- Promising new products
- Pharmacologic agents (such as drugs or biologics)
- Behavioral interventions
- Medical or assistive devices
- Clinical guidance approaches
- Emerging methods or technologies that could shift practice
Is the program only interested in certain topics?
Yes. A central feature is alignment with the fiscal year 2023 ARP Clinical Trial Award Areas of Interest. Applicants are strongly encouraged to design their clinical trial around one of these priority topics.
What if my proposed clinical trial does not clearly align with an Area of Interest?
If a proposal does not clearly fit an Area of Interest, the application must make a convincing case that the study still addresses an important and significant problem affecting individuals with ASD. The expectation is that applicants explain why the trial matters now and how it could improve outcomes or address unmet needs.
What does "rapid launch and execution" mean in this context?
Based on the description, it means the program is prioritizing clinical trials that are ready to move into real-world human testing without needing extensive preclinical development first, with an emphasis on timely initiation and completion of the trial work.
Is this opportunity focused on treatment only, or also management of ASD?
It covers both treatment and management. The supported clinical trials must be aimed at improving treatment approaches and/or how ASD is managed in clinical or community-based care.
Who runs the award program?
The opportunity is run through USAMRAA under the Department of Defense Autism Research Program (ARP).
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is HT9425 23 ARP CTA.
What is the CFDA number and program category?
The listing is in the Science and Technology and other Research and Development category and includes CFDA 12.420.
What type of funding instrument is used?
The funding may be made through either a grant or a cooperative agreement. This suggests that, depending on the award structure, some projects may involve more active involvement or coordination with the funding agency.
Who is eligible to apply?
Eligibility is described as unrestricted, meaning it is broadly open to many entity types. Applicants are still expected to check the full opportunity text for any clarifications or details.
When was this opportunity posted?
The posting date is March 3, 2023.
What was the original closing date?
The original closing date listed is July 20, 2023.
How many awards are expected?
The notice indicates an expectation of about two awards.
Is there an award ceiling (maximum funding amount)?
The award ceiling is listed as 0 in the summary field. As described, this typically indicates that the ceiling was not specified in the summary field rather than indicating that no funding is available.
What makes an application competitive based on the summary?
Based on the information provided, the opportunity rewards: readiness to run a real clinical trial in people, clear alignment with the FY2023 Areas of Interest (or a strong justification if not aligned), and a credible pathway to improving treatment or management outcomes for individuals with ASD.
What types of projects are least likely to fit this mechanism?
Projects that are primarily preclinical, exploratory, mechanistic, or focused on laboratory development without a human clinical trial component are described as not fitting this award.
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