DoD Peer Review Orthopaedic, Clinical Trial Award | W81XWH 19 PRORP CTA

PRORP Clinical Trial Award (CTA) - Frequently Asked Questions

What is the PRORP Clinical Trial Award (CTA)?

The Peer Reviewed Orthopaedic Research Program (PRORP) Clinical Trial Award (CTA) is a U.S. Department of Defense funding opportunity intended to accelerate the launch of human clinical trials that could noticeably improve outcomes for military-relevant orthopaedic injuries.

Who issues this funding opportunity?

This opportunity was issued by the Department of Defense (DoD), Department of the Army, through the U.S. Army Medical Research Acquisition Activity (USAMRAA).

What is the Funding Opportunity Number?

The Funding Opportunity Number (FON) is W81XWH-19-PRORP-CTA.

What is the CFDA number for this program?

The CFDA number listed for this discretionary research and development program is 12.420.

What types of injuries is the CTA meant to address?

The CTA is focused on orthopaedic injuries relevant to the military, including both combat-related trauma and non-battle orthopaedic injuries that can significantly affect unit readiness, return-to-duty timelines, and return-to-work rates.

What kind of impact is the program looking for from proposed trials?

Applicants are expected to address practical impact, including how the proposed clinical trial could help deliver effective care closer to the point of injury and/or shorten the time required for injured service members (and similar patient populations) to safely regain function and resume duty or work.

Is this award limited to clinical trials, or can it fund other kinds of clinical research?

This award mechanism is strictly limited to clinical trials and does not support general clinical research.

How does the CTA differ from the PRORP Clinical Translational Research Award (CTRA)?

The CTA only supports studies that meet the definition of a clinical trial (prospective assignment of human subjects to an intervention, including placebo or control, to measure effects on biomedical or behavioral health outcomes). By contrast, the CTRA can support broader clinical research projects.

What is the definition of a clinical trial for this opportunity?

For this opportunity, a clinical trial is a study in which human subjects are prospectively assigned to an intervention (including placebo or control conditions) in order to measure effects on biomedical or behavioral health outcomes.

What stages of clinical trials does the CTA support?

The CTA is designed to accommodate a range of trial maturity levels, from small early-stage efforts (such as pilot studies, first-in-human trials, or Phase 0 feasibility studies) through larger trials intended to test efficacy in appropriate patient populations.

Does the CTA fund preclinical or animal research?

No. Preclinical work is not funded under this mechanism, and animal studies are explicitly not allowed.

If a project includes preclinical aims, is there another PRORP mechanism mentioned?

Yes. Applicants with preclinical aims are directed toward a different PRORP mechanism: the Applied Research Award.

What funding instruments are available under this opportunity?

The announcement indicates that funding may be provided through cooperative agreements and grants.

How many awards were estimated for the FY19 posting?

The FY19 posting listed an estimated five awards.

When was the original closing date for the FY19 posting?

The original closing date listed was September 18, 2019.

Who is eligible to apply?

Eligibility is described as unrestricted, meaning it is open to any entity type, subject to any additional eligibility notes that may be included in the full announcement.

What is the FY19 Rehabilitation Option and what is it tied to?

In FY19, a Rehabilitation Option was offered under the Translation of Early Findings - Soft Tissue Trauma focus area. It provides additional support for interdisciplinary projects that intentionally combine surgical and rehabilitation approaches into one cohesive clinical trial strategy.

What does the Rehabilitation Option mean by "surgical strategies"?

In this context, "surgical strategies" include reconstruction and repair, as well as the use of biologics, pharmaceuticals, and devices aimed at restoring tissue architecture and function after traumatic injury.

What does the Rehabilitation Option mean by "rehabilitative strategies"?

"Rehabilitative strategies" are approaches that restore function and independence after injury or illness.

Does the Rehabilitation Option support running separate surgical and rehab efforts in parallel?

No. The stated intent is not to run parallel tracks, but to integrate surgical and rehabilitation perspectives so that the combined approach improves functional recovery more than either approach would alone, ideally following patients from acute management through longer-term rehabilitation.

Are there specific team composition requirements for the Rehabilitation Option?

Yes. Applications under this option must include at least one investigator with orthopaedic rehabilitation expertise and at least one practicing clinician specializing in orthopaedic or trauma care.

Is a Letter of Collaboration required for the Rehabilitation Option?

Yes. A formal Letter of Collaboration from the rehabilitation expert is required.

What regulatory planning expectations are emphasized for CTA applications?

The announcement emphasizes that CTA-funded work is expected to be trial-ready and places heavy emphasis on regulatory planning, including planning around FDA requirements for drugs and devices and host-country regulatory submissions for international sites.

When might an IND be required, and what rules are referenced?

If the trial uses a drug that is not FDA-approved for the intended investigational use, an Investigational New Drug (IND) application may be required under 21 CFR 312.

If an IND is not required, what documentation is expected?

The applicant must provide evidence from the relevant Institutional Review Board (IRB) or the FDA indicating that an IND is not required.

If an IND is required, what is the submission timeline?

If an IND is required, it must be submitted within 6 months of the award date.

Does the IND need to match the product and indication in the trial?

Yes. The IND must match the specific product and indication being tested (not a derivative or alternate version).

When might an IDE be required, and what rules are referenced?

For devices, an Investigational Device Exemption (IDE) may be required under 21 CFR 812.

If an IDE is not needed or qualifies as abbreviated, what is required?

Documentation is required if an IDE is not needed or qualifies as abbreviated.

If an IDE is required, what is the submission timeline?

If applicable, IDE submission is required within 6 months of the award date.

What additional regulatory requirement applies to trials conducted at international sites?

For trials conducted at international sites, the award requires evidence that appropriate submissions have been made to host-country regulatory authorities within the same 6-month window.

Can funding be withdrawn for missing regulatory submission timelines?

Yes. The government explicitly reserves the right to withdraw funding if required IND, IDE, or international regulatory submissions are not made on time.

What does the program history suggest about competitiveness?

The announcement notes that since the CTA mechanism began in FY09, 156 applications had been received and 31 were recommended for funding, indicating the program is competitive and selective.

What is the overarching goal of CTA-funded trials in terms of patient outcomes?

The CTA aims to support clinical trials that can lead to tangible clinical impact, including better outcomes for orthopaedic trauma and other readiness-related injuries, and improvements in functional recovery and timelines back to duty or work.