Opportunity Information: Apply for W81XWH 14 PRORP CTDA
Apply for W81XWH 14 PRORP CTDA
- 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 Peer Reviewed Orthopaedic Clinical Trial Development 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 Apr 30, 2014 and posted on Apr 30, 2014.
- Applicants must submit their applications by Oct 24, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $1,200,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 4 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 Peer Reviewed Orthopaedic Clinical Trial Development Award (PRORP CTDA; Funding Opportunity Number W81XWH-14-PRORP-CTDA) is a Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA) funding opportunity designed to move orthopaedic injury care closer to real-world clinical testing. Rather than paying for a full clinical trial, this award is meant to cover the planning and development work that has to happen before a strong, feasible, and well-justified clinical trial can begin. The intent is to build trial-ready packages for studies that could meaningfully improve recovery and long-term outcomes for Warfighters and Veterans dealing with traumatic orthopaedic injuries, especially those associated with combat-related trauma.
Projects supported under this mechanism can focus on essentially any aspect of orthopaedic injury treatment as long as they clearly fit at least one of the program's designated focus areas for FY14. The opportunity explicitly welcomes clinical trial concepts that evaluate promising new products, drugs or biologics, medical devices, clinical guidance approaches, and emerging technologies. A central requirement is that every application must make a convincing case for military and/or Veteran relevance. If the injury area is not directly battle-related, applicants still have a path to eligibility, but they must clearly explain how the work could improve unit readiness and increase return-to-duty or return-to-work rates, especially in contexts where historical return-to-work outcomes are poor (less than 50 percent) or recovery timelines are prolonged (longer than 6 months). In other words, the program is not only interested in whether something works clinically; it is also looking for whether it could realistically improve functional recovery in ways that matter for operational readiness and post-service quality of life.
Collaboration is a strong theme in this announcement. The DoD encourages applicants to work with military or Department of Veterans Affairs (VA) researchers and clinicians, and it also encourages designing future studies that include active duty Service members and/or Veterans as all or part of the intended participant population. This reflects the program's emphasis on ensuring that what is being developed is applicable to, and informed by, the populations most affected by traumatic orthopaedic injuries in military contexts.
The FY14 PRORP CTDA focus areas highlight specific clinical problems that the DoD views as both urgent and impactful. These include: reducing secondary health effects that arise after reduced mobility from traumatic neuromusculoskeletal injury (examples listed include joint contracture, obesity, metabolic syndrome, and poor bone health); developing strategies to inhibit neuromas at surgical or amputation sites; applying novel or innovative technologies and materials to improve prosthetic and orthotic device development; advancing research toward osseointegration for upper extremity prostheses; testing treatments for non-battle orthopaedic injuries that significantly affect readiness and have historically poor or slow return-to-work outcomes; evaluating physical therapy and occupational therapy interventions to determine optimal rehabilitation and to compare the effectiveness of different PT/OT regimens; and developing clinical trials intended to restore function after volumetric muscle loss. Taken together, these areas span complications after injury, pain and nerve-related problems, device innovation, rehabilitation science, and functional restoration, reflecting an end-to-end view of recovery.
From an administrative standpoint, this is a discretionary funding opportunity using either a cooperative agreement or a grant as the funding instrument type, categorized under science and technology and other research and development. The CFDA listing is 12.420 (Military Medical Research and Development). The program anticipated making about 4 awards, with an estimated total funding amount of $1,200,000, and it did not require cost sharing or matching. Eligibility was listed as unrestricted (open to any type of entity), subject to any additional clarifications contained in the full announcement. The opportunity was originally posted April 30, 2014, with an application closing date of October 24, 2014, and it was later archived on November 23, 2014.
For applicants needing assistance accessing the full announcement or navigating submission systems, the listed contact was the CDMRP Help Desk (phone 301-682-5507; email help@eBRAP.org), which aligns with the DoD's common electronic biomedical research application portal support structure.
Frequently Asked Questions (FAQs)
What is the PRORP Clinical Trial Development Award (CTDA)?
The DoD Peer Reviewed Orthopaedic Clinical Trial Development Award (PRORP CTDA; Funding Opportunity Number W81XWH-14-PRORP-CTDA) is a U.S. Army Medical Research Acquisition Activity (USAMRAA) funding opportunity intended to move orthopaedic injury care closer to real-world clinical testing. It supports the planning and development work needed to create a strong, feasible, and well-justified clinical trial concept.
Does this award fund a full clinical trial?
No. This mechanism is specifically described as supporting the planning and development work that must occur before a full clinical trial can begin, with the goal of producing trial-ready packages rather than paying for the complete trial.
What is the main purpose of this award?
The intent is to develop trial-ready packages for studies that could meaningfully improve recovery and long-term outcomes for Warfighters and Veterans with traumatic orthopaedic injuries, particularly those linked to combat-related trauma.
Who is the sponsoring/issuing organization?
The opportunity is a Department of the Army program managed through the U.S. Army Medical Research Acquisition Activity (USAMRAA).
What kinds of projects can be supported?
Projects may address essentially any aspect of orthopaedic injury treatment, as long as they clearly align with at least one of the FY14 PRORP CTDA focus areas listed in the announcement.
Are clinical trial concepts involving new products or technologies allowed?
Yes. The opportunity explicitly welcomes clinical trial concepts evaluating promising new products, drugs or biologics, medical devices, clinical guidance approaches, and emerging technologies.
Is military and/or Veteran relevance required?
Yes. Every application must make a convincing case for military and/or Veteran relevance.
What if the targeted injury is not directly battle-related?
The announcement indicates there is still a path to eligibility, but applicants must clearly explain how the work could improve unit readiness and increase return-to-duty or return-to-work rates, especially where historical return-to-work outcomes are poor (less than 50 percent) or recovery timelines are prolonged (longer than 6 months).
Does the program care only about clinical effectiveness?
No. Beyond clinical outcomes, the opportunity emphasizes whether the proposed work could realistically improve functional recovery in ways that matter for operational readiness and post-service quality of life.
Is collaboration with military or VA partners encouraged?
Yes. The DoD encourages applicants to collaborate with military or Department of Veterans Affairs (VA) researchers and clinicians.
Does the program encourage including Service members and/or Veterans in the future study population?
Yes. The announcement encourages designing future studies that include active duty Service members and/or Veterans as all or part of the intended participant population.
What are the FY14 PRORP CTDA focus areas?
The FY14 focus areas listed include:
- Reducing secondary health effects after reduced mobility from traumatic neuromusculoskeletal injury (examples include joint contracture, obesity, metabolic syndrome, and poor bone health).
- Developing strategies to inhibit neuromas at surgical or amputation sites.
- Applying novel or innovative technologies and materials to improve prosthetic and orthotic device development.
- Advancing research toward osseointegration for upper extremity prostheses.
- Testing treatments for non-battle orthopaedic injuries that significantly affect readiness and have historically poor or slow return-to-work outcomes.
- Evaluating physical therapy and occupational therapy interventions to determine optimal rehabilitation and to compare the effectiveness of different PT/OT regimens.
- Developing clinical trials intended to restore function after volumetric muscle loss.
Does the opportunity cover rehabilitation research like physical therapy and occupational therapy?
Yes. One of the listed focus areas is evaluating physical therapy and occupational therapy interventions to determine optimal rehabilitation and to compare the effectiveness of different PT/OT regimens.
Does the opportunity support prosthetics and orthotics development?
Yes. The focus areas include applying novel or innovative technologies and materials to improve prosthetic and orthotic device development, as well as advancing research toward osseointegration for upper extremity prostheses.
Does the opportunity address complications after injury such as reduced mobility effects?
Yes. A focus area is reducing secondary health effects that arise after reduced mobility from traumatic neuromusculoskeletal injury, with examples including joint contracture, obesity, metabolic syndrome, and poor bone health.
Does the opportunity include approaches for neuroma prevention or treatment?
Yes. A listed focus area is developing strategies to inhibit neuromas at surgical or amputation sites.
What type of funding mechanism is used?
This is described as a discretionary funding opportunity using either a cooperative agreement or a grant as the funding instrument type.
What category is this opportunity listed under?
It is categorized under science and technology and other research and development.
What is the CFDA number for this program?
The CFDA listing provided is 12.420 (Military Medical Research and Development).
How many awards were anticipated and what was the estimated total funding?
The announcement anticipated making about 4 awards, with an estimated total funding amount of $1,200,000.
Is cost sharing or matching required?
No. The opportunity states that cost sharing or matching was not required.
Who was eligible to apply?
Eligibility was listed as unrestricted (open to any type of entity), subject to any additional clarifications contained in the full announcement.
When was the opportunity posted and when did it close?
It was originally posted on April 30, 2014, and the application closing date was October 24, 2014.
Is this opportunity still open?
No. The opportunity was archived on November 23, 2014.
Who can applicants contact for help with the announcement or submission systems?
The listed contact was the CDMRP Help Desk: phone 301-682-5507; email help@eBRAP.org.
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