Opportunity Information: Apply for W81XWH 16 ARP CTA
Apply for W81XWH 16 ARP CTA
- The DOD-AMRAA 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 Apr 28, 2016 and posted on Apr 28, 2016.
- Applicants must submit their applications by Sep 29, 2016. (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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Opportunity Summary:
The DoD Autism Clinical Trial Award (funding opportunity number W81XWH-16-ARP-CTA) is a U.S. Department of Defense Autism Research Program (ARP) funding opportunity focused specifically on clinical trials aimed at improving the treatment or management of autism spectrum disorder (ASD). The central purpose of the award is to support research that could make a major, real-world difference for people with ASD by testing an intervention directly in human participants and measuring outcomes related to safety and/or how well the intervention works. Unlike broader research mechanisms that may support early-stage discovery, this award is narrowly oriented toward studies that are ready to be evaluated in a clinical trial setting.
A key requirement is that the proposed work must be a clinical trial, and funds cannot be used for preclinical studies. In this announcement, a clinical trial is defined as a prospective study where human subjects are enrolled in advance and then receive an intervention that is being tested. The intervention can take many forms, including a device, drug, biologic, surgical procedure, rehabilitative approach, behavioral intervention, or other type of treatment strategy. The trial must assess measurable outcomes tied to safety, effectiveness, and/or efficacy, and those outcomes must reflect a direct effect on the human subject as a result of the intervention or the interaction with the study protocol. The announcement also clarifies that "human subjects" refers to individuals who will be recruited for or participate in the clinical trial.
For applicants whose projects are not yet at the stage of human testing, the opportunity explicitly points them elsewhere: investigators pursuing preclinical research are directed to consider the ARP Idea Development Award (W81XWH-16-ARP-IDA) instead. This distinction signals that the Clinical Trial Award is intended for proposals that have sufficient rationale and readiness to move into human subject research and can credibly execute a trial design with clear endpoints.
Administratively, the opportunity was posted on April 28, 2016, created the same day, and carried a closing date of September 29, 2016 (both the original and current closing dates match, indicating no extension was listed in the source information). It falls under the category of discretionary funding and supports science and technology and other research and development activities. Awards could be made either as grants or cooperative agreements, and the responsible agency listed is DOD-AMRAA. Eligibility is described as unrestricted, meaning it is open to any type of entity, subject to any additional eligibility clarifications that may appear in the full announcement text. The listing includes a CFDA number of 12.420 and indicates an expectation of two awards, while the award ceiling amount is not provided in the source data.
FAQs: DoD Autism Clinical Trial Award (W81XWH-16-ARP-CTA)
1) What is the DoD Autism Clinical Trial Award?
The DoD Autism Clinical Trial Award is a U.S. Department of Defense (DoD) Autism Research Program (ARP) funding opportunity focused specifically on clinical trials intended to improve the treatment or management of autism spectrum disorder (ASD). The intent is to support research that can make a major, real-world difference for people with ASD by directly testing an intervention in human participants and measuring outcomes related to safety and/or how well the intervention works.
2) What is the funding opportunity number for this award?
The funding opportunity number is W81XWH-16-ARP-CTA.
3) What is the main purpose of this award?
The central purpose is to fund studies that are ready to be evaluated in a clinical trial setting and that test an intervention in human subjects, with measurable outcomes that address safety, effectiveness, and/or efficacy.
4) Is a clinical trial required to apply?
Yes. A key requirement is that the proposed work must be a clinical trial as defined in the announcement. This award is narrowly oriented toward clinical trials rather than early-stage discovery or preclinical work.
5) Are preclinical studies allowed under this award?
No. Funds cannot be used for preclinical studies under this opportunity.
6) How does this announcement define a "clinical trial"?
In this announcement, a clinical trial is defined as a prospective study in which human subjects are enrolled in advance and then receive an intervention that is being tested.
7) What types of interventions can be tested in the clinical trial?
The intervention can take many forms, including a device, drug, biologic, surgical procedure, rehabilitative approach, behavioral intervention, or another type of treatment strategy.
8) What outcomes must the clinical trial measure?
The trial must assess measurable outcomes tied to safety, effectiveness, and/or efficacy. Those outcomes must reflect a direct effect on the human subject as a result of receiving the intervention or interacting with the study protocol.
9) Who counts as a "human subject" for this opportunity?
"Human subjects" refers to individuals who will be recruited for or participate in the clinical trial.
10) What should investigators do if their project is not ready for human testing?
If the work is not yet at the stage of human testing (for example, it is preclinical), investigators are directed to consider the ARP Idea Development Award (W81XWH-16-ARP-IDA) instead.
11) What does this award focus on compared with broader research mechanisms?
Unlike broader mechanisms that may support early-stage discovery, this award is specifically intended for proposals with sufficient rationale and readiness to move into human subject research and that can credibly execute a clinical trial design with clear endpoints.
12) Which agency is responsible for this opportunity?
The responsible agency listed is DOD-AMRAA.
13) What kind of funding category does this opportunity fall under?
It is listed as discretionary funding.
14) What activities does the funding support?
The opportunity supports science and technology and other research and development activities, specifically in the form of autism-related clinical trials.
15) What types of awards may be issued?
Awards could be made either as grants or as cooperative agreements.
16) Who is eligible to apply?
Eligibility is described as unrestricted, meaning it is open to any type of entity, subject to any additional eligibility clarifications that may appear in the full announcement text.
17) What is the CFDA number associated with this opportunity?
The CFDA number listed is 12.420.
18) When was the opportunity posted and created?
The opportunity was posted on April 28, 2016, and it was created the same day.
19) What was the closing date for applications?
The closing date listed is September 29, 2016. The original and current closing dates match in the source information, indicating no extension was listed there.
20) How many awards were expected?
The listing indicates an expectation of two awards.
21) What is the maximum award amount (award ceiling)?
The award ceiling amount is not provided in the source data.
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