Opportunity Information: Apply for W81XWH 21 ARP CTA
The Department of Defense Autism Research Program (ARP) Clinical Trial Award (Funding Opportunity Number W81XWH 21 ARP CTA) is a discretionary research and development funding opportunity administered through the U.S. Army Medical Research Acquisition Activity (USAMRAA). Its purpose is to speed up the launch and execution of clinical trials that could meaningfully improve the treatment or day-to-day management of autism spectrum disorder (ASD). The emphasis is on getting high-potential interventions into well-designed clinical testing quickly, with an expectation that the results could have major practical impact for individuals with ASD and their families.
This award mechanism is specifically intended to fund clinical trials, not early-stage or exploratory laboratory work. In other words, the proposed project must be a true clinical trial, and the funds cannot be used for preclinical studies. The program is open to trials that evaluate a wide range of approaches, including promising new products, pharmacologic agents such as drugs or biologics, behavioral interventions, medical devices, clinical guidance approaches, and emerging technologies. The common thread is that the intervention or approach should be ready for clinical testing and structured in a way that can generate meaningful evidence about effectiveness, safety, feasibility, or other clinically relevant outcomes.
Applicants are strongly encouraged to align their proposals with one of the FY21 ARP Clinical Trial Award Areas of Interest. If a proposal does not directly fit within an identified Area of Interest, it must include a clear explanation of why the study still addresses an important and relevant problem for people with ASD. This signals that the program is prioritizing targeted impact areas while still leaving room for compelling trials that can justify their relevance and importance even if they fall outside the predefined topics.
From an administrative standpoint, the opportunity allows for funding through either a cooperative agreement or a grant, and it falls under CFDA number 12.420 (Science and Technology and other Research and Development). Eligibility is described as unrestricted, meaning it is broadly open to many entity types, although applicants are expected to follow any additional eligibility clarifications included in the full opportunity text. The opportunity was created on March 19, 2021, with an original closing date of August 5, 2021, and it anticipated making about two awards. The listed award ceiling is shown as 0, which typically indicates that the maximum funding level is not specified in the summary field and would need to be confirmed in the full announcement or associated program guidance.
Overall, this funding opportunity is aimed at supporting near-term, clinically focused research that can translate into real-world benefits for ASD, with funding reserved for projects that are ready to be tested in human participants using a formal clinical trial design rather than earlier-stage preclinical development.Apply for W81XWH 21 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 Research Program, 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 19, 2021.
- Applicants must submit their applications by Aug 05, 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 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 (W81XWH 21 ARP CTA)
What is the Autism Research Program (ARP) Clinical Trial Award?
The ARP Clinical Trial Award is a Department of Defense (DoD) research funding opportunity intended to speed up the launch and execution of clinical trials that could meaningfully improve the treatment or day-to-day management of autism spectrum disorder (ASD).
What is the main goal of this funding opportunity?
The main goal is to move high-potential ASD interventions into well-designed clinical testing quickly, with an expectation that trial results could have major practical impact for individuals with ASD and their families.
Who administers this award?
This opportunity is administered through the U.S. Army Medical Research Acquisition Activity (USAMRAA).
What is the Funding Opportunity Number (FON) for this award?
The Funding Opportunity Number is W81XWH 21 ARP CTA.
Is this a grant or a cooperative agreement?
The opportunity allows for funding through either a cooperative agreement or a grant.
What type of projects does this award fund?
This mechanism is specifically intended to fund clinical trials in ASD, focused on interventions or approaches that are ready for clinical testing in human participants and can generate meaningful evidence related to effectiveness, safety, feasibility, or other clinically relevant outcomes.
Does the project have to be a true clinical trial?
Yes. The proposed project must be a true clinical trial. The award is designed for clinical testing rather than exploratory or early-stage research.
Can funds be used for preclinical studies or lab-based exploratory work?
No. Funds cannot be used for preclinical studies, and the mechanism is not intended for early-stage or exploratory laboratory work.
What kinds of interventions or approaches are eligible to be tested?
The program is open to clinical trials evaluating a wide range of approaches, including new products, pharmacologic agents (such as drugs or biologics), behavioral interventions, medical devices, clinical guidance approaches, and emerging technologies, as long as they are ready for clinical testing.
What does "ready for clinical testing" mean in the context of this opportunity?
Based on the program description, "ready for clinical testing" means the intervention or approach is sufficiently developed to be evaluated in human participants using a formal clinical trial design, rather than requiring additional preclinical development first.
Is the opportunity focused more on launching trials quickly or on early discovery?
It is focused on launching and executing clinical trials quickly. The intent is near-term, clinically focused research that can translate into real-world benefits, not early discovery or preclinical development.
Do applicants need to align their proposal with specific Areas of Interest?
Applicants are strongly encouraged to align their proposals with one of the FY21 ARP Clinical Trial Award Areas of Interest.
What if a proposed trial does not fit an identified Area of Interest?
If a proposal does not directly fit within an identified Area of Interest, it must include a clear explanation of why the study still addresses an important and relevant problem for people with ASD.
What is the CFDA number associated with this opportunity?
The opportunity falls under CFDA number 12.420 (Science and Technology and other Research and Development).
Who is eligible to apply?
Eligibility is described as unrestricted, meaning it is broadly open to many entity types. Applicants should still follow any additional eligibility clarifications included in the full opportunity text.
How many awards were anticipated?
The opportunity anticipated making about two awards.
When was this funding opportunity created?
The opportunity was created on March 19, 2021.
What was the original closing date?
The original closing date listed was August 5, 2021.
What is the maximum award amount (award ceiling)?
The listed award ceiling is shown as 0 in the summary, which typically indicates that the maximum funding level is not specified in that summary field. The maximum would need to be confirmed in the full announcement or associated program guidance.
What outcomes does the program expect trials to address?
The program emphasizes clinically relevant outcomes and supports trials structured to generate meaningful evidence about effectiveness, safety, feasibility, or other outcomes that matter for treatment or day-to-day management of ASD.
What is the overall emphasis of the ARP Clinical Trial Award?
The overall emphasis is on supporting near-term, clinically focused research with the potential to translate into real-world benefits for individuals with ASD, funding only those projects that are ready to be tested in human participants using a formal clinical trial design.
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