Opportunity Information: Apply for W81XWH 10 ARP CTA
Apply for W81XWH 10 ARP CTA
- The 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 Military Medical Research and Development.
- This funding opportunity was created on Feb 17, 2010 and posted on Feb 16, 2010.
- Applicants must submit their applications by Jul 28, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $3,200,000.00 to eligible and selected applicants.
- 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-10-ARP-CTA) is a Department of the Army/USAMRAA grant and cooperative agreement program under CFDA 12.420 (Military Medical Research and Development) designed specifically to fund clinical trials that could meaningfully improve the lives of individuals with Autism Spectrum Disorder (ASD). The central requirement is that the proposed work must be a true clinical trial, meaning it involves the prospective enrollment of human volunteers and tests an intervention, such as a drug, device, behavioral approach, surgical procedure, or other therapeutic strategy, with outcomes that can be measured. This mechanism is aimed at later-stage, patient-facing studies rather than basic research, and the trial is expected to be ready to launch quickly, with a start date no later than 12 months after the award is made.
Applications are expected to show that the research team can realistically recruit and study an appropriate participant population. That means demonstrating access to a suitable pool of individuals with ASD, explaining how enrollment targets will be met, and addressing practical factors that can affect recruitment and interpretation, including how existing standards of care might influence who is eligible or willing to participate. Proposals also need to lay out clear, focused clinical endpoints that match the proposed design and the planned sample size, so that the study is structured to answer a specific, meaningful question rather than collecting broad, unfocused data. Where relevant (especially for drug-based interventions), applicants should include pharmacokinetic and pharmacodynamic measures. A well-developed statistical analysis plan is required, including a power analysis tied to the recruitment projections, showing that the trial is adequately sized to meet its objectives.
Operational readiness and oversight are a major emphasis. Applicants are expected to include a study coordinator with responsibility for driving the protocol through regulatory approvals (including IRB and Human Subjects Research Review Board processes), coordinating activities across participating sites if the trial is multi-site, and managing participant recruitment. The program also expects evidence of institutional support, reflecting that the applicant organization has the infrastructure and commitment to carry out a complex human study. Finally, proposals should make a compelling case for impact, explaining how the results could translate into real benefits for people with ASD, not just incremental knowledge.
If the trial is intended to support an eventual submission to the U.S. Food and Drug Administration, the announcement strongly signals that regulatory groundwork should already be underway: an Investigational New Drug (IND) application or Investigational Device Exemption (IDE) should be submitted before the grant application. After award, the government reserves the right to withdraw funding if an active marketing-approval exemption (IND/IDE as applicable) is not obtained within 6 months of the award date, which underscores that this mechanism is built for projects that are close to being trial-ready.
The opportunity also requires preliminary data relevant to the proposed trial. Importantly, the preliminary evidence can come from outside the ASD field, and it can include unpublished results generated by the PI, the research team, or named collaborators, as long as it supports the rationale for the trial. More broadly, the proposal needs to rest on a strong scientific foundation supported by careful reasoning and a critical review of existing literature, demonstrating why the intervention is promising and why the trial design is appropriate.
Because the work involves human subjects and potentially human biological substances, DoD-specific protections apply. In addition to local Institutional Review Board review, all DoD-funded human subjects research must be reviewed and approved by the USAMRMC Office of Research Protections, Human Research Protection Office (HRPO). Local IRB approval is not required at the time of application submission, but applicants should plan for a lengthy regulatory pathway; the announcement advises allowing at least 6 months for regulatory review and approvals. This reflects the fact that DoD requirements can be more detailed than typical local IRB submissions and may require additional documentation beyond what an institution normally requests.
From a funding and administrative standpoint, the program was posted in February 2010 with a closing date of July 28, 2010, and an archive date of August 27, 2010. It anticipated making about 2 awards with an estimated total funding amount of $3.2 million, with no cost sharing or matching requirement. Eligibility is described as unrestricted, meaning applications could come from a wide range of entity types unless otherwise limited by additional eligibility language in the full announcement. For applicants needing help accessing or submitting materials, the announcement lists contact points through CDMRP and program assistance lines.
FAQs: DoD Autism Clinical Trial Award (W81XWH-10-ARP-CTA)
What is the DoD Autism Clinical Trial Award?
The DoD Autism Clinical Trial Award (Funding Opportunity Number W81XWH-10-ARP-CTA) is a Department of the Army/USAMRAA grant and cooperative agreement program under CFDA 12.420 (Military Medical Research and Development). It is specifically intended to fund clinical trials that could meaningfully improve the lives of individuals with Autism Spectrum Disorder (ASD).
What types of studies does this award fund?
This mechanism funds true clinical trials that prospectively enroll human volunteers and test an intervention with measurable outcomes. Interventions may include a drug, device, behavioral approach, surgical procedure, or other therapeutic strategy.
What does the program mean by a "true clinical trial"?
A true clinical trial, as described in the opportunity, involves prospective enrollment of human participants and evaluates an intervention, with outcomes that can be measured to determine the effect of that intervention.
Is this opportunity meant for basic research or later-stage clinical research?
It is aimed at later-stage, patient-facing studies rather than basic research. The expectation is that the project is close to being ready to run as an actual clinical trial.
How quickly must the trial be ready to start?
The clinical trial is expected to be ready to launch quickly, with a start date no later than 12 months after the award is made.
What are the expectations for participant recruitment?
Applications are expected to show that the research team can realistically recruit and study an appropriate participant population. This includes demonstrating access to a suitable pool of individuals with ASD and explaining how enrollment targets will be met.
What recruitment factors should applicants address?
The opportunity indicates applicants should address practical factors that can affect recruitment and interpretation, including how existing standards of care might influence who is eligible or willing to participate.
What kind of endpoints does the program expect?
Proposals should include clear, focused clinical endpoints that match the proposed design and the planned sample size, so the study answers a specific, meaningful question rather than collecting broad, unfocused data.
Are pharmacokinetic (PK) and pharmacodynamic (PD) measures required?
Where relevant, especially for drug-based interventions, applicants should include pharmacokinetic and pharmacodynamic measures.
Is a statistical analysis plan required?
Yes. The opportunity calls for a well-developed statistical analysis plan, including a power analysis tied to recruitment projections, to show the trial is adequately sized to meet its objectives.
Does the application need to include a study coordinator?
Yes. Applicants are expected to include a study coordinator responsible for driving the protocol through regulatory approvals (including IRB and Human Subjects Research Review Board processes), coordinating across sites for multi-site trials, and managing participant recruitment.
What is meant by "institutional support"?
The program expects evidence of institutional support, reflecting that the applicant organization has the infrastructure and commitment needed to conduct a complex human subjects study.
How important is "impact" in the application?
Applicants are expected to make a compelling case for impact by explaining how results could translate into real benefits for people with ASD, rather than only adding incremental knowledge.
If the trial is intended to support an eventual FDA submission, what does the opportunity expect?
The announcement strongly signals that regulatory groundwork should already be underway. For trials intended to support an eventual U.S. Food and Drug Administration submission, an Investigational New Drug (IND) application or Investigational Device Exemption (IDE) should be submitted before the grant application.
What happens if an IND or IDE is not obtained after award?
After award, the government reserves the right to withdraw funding if an active marketing-approval exemption (IND/IDE, as applicable) is not obtained within 6 months of the award date.
Is preliminary data required?
Yes. The opportunity requires preliminary data relevant to the proposed trial.
Can preliminary data come from outside the ASD field?
Yes. The opportunity states that preliminary evidence can come from outside the ASD field, as long as it supports the rationale for the proposed trial.
Can unpublished data be used as preliminary evidence?
Yes. The preliminary evidence can include unpublished results generated by the PI, the research team, or named collaborators, provided it supports the trial rationale.
What scientific foundation is expected in the proposal?
The proposal is expected to rest on a strong scientific foundation supported by careful reasoning and a critical review of existing literature, demonstrating why the intervention is promising and why the trial design is appropriate.
What human subjects oversight applies to this DoD-funded research?
In addition to local Institutional Review Board (IRB) review, all DoD-funded human subjects research must be reviewed and approved by the USAMRMC Office of Research Protections, Human Research Protection Office (HRPO).
Is local IRB approval required at the time of application submission?
No. The opportunity states that local IRB approval is not required at the time the application is submitted.
How long should applicants plan for regulatory review and approvals?
Applicants should plan for a lengthy regulatory pathway. The announcement advises allowing at least 6 months for regulatory review and approvals, noting that DoD requirements can be more detailed than typical local IRB submissions and may require additional documentation.
When was this funding opportunity posted and when did it close?
The program was posted in February 2010, with a closing date of July 28, 2010, and an archive date of August 27, 2010.
How many awards and how much total funding were anticipated?
The opportunity anticipated making about 2 awards, with an estimated total funding amount of $3.2 million.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
Who is eligible to apply?
Eligibility is described as unrestricted, meaning applications could come from a wide range of entity types unless otherwise limited by additional eligibility language in the full announcement.
Where can applicants get help with accessing or submitting materials?
The announcement lists contact points through CDMRP and program assistance lines for applicants needing help accessing or submitting materials.
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