Opportunity Information: Apply for W81XWH 12 DMRDP CTA RPS
Apply for W81XWH 12 DMRDP CTA RPS
- The Dept. of the Army USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "Defense Medical Research and Development Program Clinical Trial Award Regenerative Medicine, Pain, Sensory System" 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 Apr 20, 2011 and posted on Apr 19, 2011.
- Applicants must submit their applications by Aug 25, 2011. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $15,300,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 5 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 Defense Medical Research and Development Program (DMRDP) Clinical Trial Award for Regenerative Medicine, Pain, and Sensory System (CTA RPS) is a U.S. Army-managed funding opportunity aimed at pushing promising medical advances into early clinical testing for problems that commonly arise from combat-related trauma. The program is specifically focused on clinical trials that could significantly improve care for military service members and veterans, especially in three connected areas: regenerative medicine technologies, treatment of pain, and restoration of sensory systems such as balance, hearing, and vision. While the studies must clearly explain why the work matters to military health needs, the clinical trial does not have to enroll military participants as long as the relevance is explicit and well justified.
This award is designed for early phase human studies that evaluate the safety and efficacy of new therapies, devices, or diagnostics intended for serious and debilitating traumatic injuries. Target injury areas include extremities, skin, sensory organs/systems, and craniomaxillofacial injuries (injuries involving the head, face, jaw, and related structures). The intent is translational: moving an intervention that already has strong support from appropriate animal models into human testing to accelerate development toward real-world medical capability. Supported trial stages range from proof-of-concept efforts like first-in-human or Phase 0 studies through Phase II clinical trials. Device studies are also eligible across Class I, II, and III device trial categories. Phase III clinical trials are explicitly not allowed under this mechanism.
A key restriction is that the funding must be used to support a clinical trial and cannot be used for preclinical research. In other words, this mechanism is not meant for generating initial animal or laboratory proof; it is meant for interventions that have already cleared that bar and are ready for advanced clinical development. Projects that fit best are those with a clear path to near-term clinical impact and a strong rationale for why the intervention could meaningfully improve outcomes for trauma-related conditions relevant to military settings.
Administratively, this is a discretionary research and development funding opportunity offered by the Department of the Army through USAMRAA, using cooperative agreements and grants. The opportunity (Funding Opportunity Number W81XWH-12-DMRDP-CTA-RPS) anticipated about five awards with an estimated total funding level of $15.3 million, and it did not require cost sharing or matching. Eligibility was listed as unrestricted (open to any type of entity, subject to any specific clarifications in the full announcement). The posting timeline shows it was originally posted in April 2011 with an application deadline of August 25, 2011, and it was archived in September 2011. For assistance accessing the full announcement, applicants were directed to the CDMRP Help Desk at 301-682-5507.
Frequently Asked Questions (FAQ)
What is the DMRDP Clinical Trial Award for Regenerative Medicine, Pain, and Sensory System (CTA RPS)?
It is a U.S. Army-managed funding opportunity under the Defense Medical Research and Development Program (DMRDP) to support early-stage clinical trials aimed at improving care for combat trauma-related conditions. The focus areas are regenerative medicine technologies, treatment of pain, and restoration of sensory systems (including balance, hearing, and vision).
What kinds of medical problems is this award trying to address?
The award targets serious and debilitating traumatic injuries and conditions commonly associated with combat-related trauma. Specific injury areas highlighted include extremities, skin, sensory organs/systems, and craniomaxillofacial injuries (injuries involving the head, face, jaw, and related structures).
What research stage is this funding intended for?
This mechanism is intended for translational, early phase human clinical studies that evaluate safety and efficacy. It is meant to move interventions that already have strong supporting evidence from appropriate animal models into human testing to accelerate development toward real-world medical capability.
Which clinical trial phases are supported?
Supported trial stages range from proof-of-concept efforts such as first-in-human or Phase 0 studies through Phase II clinical trials.
Are Phase III clinical trials allowed?
No. Phase III clinical trials are explicitly not allowed under this mechanism.
Are device trials eligible under this opportunity?
Yes. Device studies are eligible, including trials involving Class I, Class II, and Class III devices.
What types of interventions can be tested in the clinical trial?
The award supports early phase clinical testing of new therapies, devices, or diagnostics intended for traumatic injuries and related conditions in the specified focus areas (regenerative medicine, pain, and sensory system restoration).
Does the clinical trial have to include military service members or veterans as participants?
No. The clinical trial does not have to enroll military participants, as long as the application clearly explains and justifies the relevance to military health needs.
How important is military relevance in the application?
Military relevance is required. Studies must clearly explain why the work matters to military health needs, even if the enrolled study population is not military.
Can this award be used to fund preclinical research (animal studies or lab proof-of-concept)?
No. A key restriction is that the funding must be used to support a clinical trial and cannot be used for preclinical research. The mechanism is not intended to generate initial animal or laboratory proof-of-concept.
What kind of evidence should exist before applying?
The opportunity is intended for interventions that already have strong support from appropriate animal models and are ready to move into human clinical testing.
What is the overall intent of this award?
The intent is to accelerate development of promising medical advances into early clinical testing, with a clear path toward near-term clinical impact for trauma-related conditions relevant to military settings.
Who administers this funding opportunity?
It is offered by the Department of the Army through USAMRAA, as a discretionary research and development funding opportunity.
What funding instruments are used for awards?
The announcement indicates the opportunity uses cooperative agreements and grants.
What is the Funding Opportunity Number for this program?
The Funding Opportunity Number is W81XWH-12-DMRDP-CTA-RPS.
How many awards were anticipated and what was the estimated total funding?
The opportunity anticipated about five awards, with an estimated total funding level of $15.3 million.
Was cost sharing or matching required?
No. The opportunity did not require cost sharing or matching.
Who was eligible to apply?
Eligibility was listed as unrestricted, meaning it was open to any type of entity (subject to any specific clarifications contained in the full announcement).
When was the opportunity posted and when were applications due?
It was originally posted in April 2011. The application deadline was August 25, 2011.
Is this funding opportunity still active?
No. The posting timeline indicates it was archived in September 2011.
Where could applicants get help accessing the full announcement?
Applicants were directed to the CDMRP Help Desk at 301-682-5507 for assistance accessing the full announcement.
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