DoD Peer Reviewed Medical Clinical Trial Award | Apply Online

Frequently Asked Questions (FAQs)

What is the PRMRP Clinical Trial Award (W81XWH 16 PRMRP CTA)?

The Peer Reviewed Medical Research Program (PRMRP) Clinical Trial Award is a Department of Defense (DoD) funding opportunity intended to support the rapid start-up and execution of clinically focused research, specifically clinical trials. The goal is to move research into practice quickly by funding trials that could meaningfully change prevention, diagnosis, treatment, or clinical management.

What is the main purpose of this award?

The central purpose is to fund clinical trials with the potential to deliver significant real-world clinical impact (not incremental progress) for diseases and conditions that fall under at least one of the Congressionally directed FY16 PRMRP Topic Areas.

Does my proposed clinical trial need to align with a specific topic area?

Yes. Applicants are expected to tie the proposed clinical trial directly to at least one of the Congressionally directed FY16 PRMRP Topic Areas and explain why the trial is responsive to that topic area.

What kind of impact is the DoD expecting from funded trials?

The opportunity emphasizes trials that could meaningfully change clinical practice or patient outcomes in prevention, diagnosis, treatment, or clinical management. The framing suggests reviewers will look for a strong case for significant clinical impact rather than small, incremental advances.

Is this award only for clinical trials?

Yes. This award is designed specifically to support clinical trials, with an emphasis on rapid implementation and a credible path to influencing clinical practice.

What stages or types of clinical trials are supported?

The award is flexible and can support a wide range of trial types and stages, including smaller early-stage studies (such as proof-of-concept studies, pilot trials, first-in-human work, or Phase 0 trials) as well as larger, more definitive trials intended to determine efficacy in relevant patient populations.

Can I propose an early-stage study like a pilot or proof-of-concept trial?

Yes. The opportunity explicitly allows smaller, early-stage efforts designed to demonstrate feasibility, establish early signals, or generate data needed to design a larger trial.

Can I propose a larger, more definitive clinical trial?

Yes. The program also supports larger trials intended to determine efficacy in relevant patient populations, as long as the trial can be implemented quickly and has a credible pathway to influencing clinical practice or outcomes.

What kinds of interventions can be evaluated under this opportunity?

The opportunity allows clinical trials evaluating a broad range of interventions and solutions, including new or promising products, pharmacologic agents (such as drugs or biologics), medical devices, clinical guidance or care pathways, and emerging approaches or technologies.

Are drugs and biologics allowed as the intervention being tested?

Yes. Pharmacologic agents such as drugs and biologics are specifically mentioned as allowable interventions for evaluation in clinical trials under this program.

Are medical devices allowed as the intervention being tested?

Yes. Medical devices are explicitly listed among the types of interventions that can be evaluated in clinical trials supported by this opportunity.

Can the trial focus on clinical guidance, care pathways, or systems-level approaches?

Yes. Clinical guidance and care pathways are specifically included, which makes the opportunity relevant to trials focused on behavioral, clinical process, and systems-level strategies, provided the study is framed as a clinical trial and aligned to an FY16 PRMRP topic area.

Do proposed studies need to be relevant to military or Veteran health needs?

Yes. A key requirement is that the proposed research is relevant to the health care needs of military Service members, Veterans, and/or other DoD beneficiaries.

Is it required to enroll military Service members or Veterans as study participants?

No. The announcement indicates that while the research must be responsive to the needs of Service members, Veterans, and/or other DoD beneficiaries, enrollment of military or Veteran participants is not required.

Can a clinical trial enrolling civilians still be competitive?

Yes. Civilian-population trials may still be competitive if the applicant clearly explains how the disease area, intervention, and expected outcomes address problems faced by Service members, Veterans, or other DoD beneficiaries, and how results could translate to those communities.

Who is the funding agency listed for this opportunity?

The agency listed is DOD-AMRAA.

What funding instruments are available under this opportunity?

The opportunity includes both grants and cooperative agreements. This suggests awards may involve varying degrees of DoD involvement in oversight or coordination depending on the project.

What is the CFDA number associated with this opportunity?

The opportunity is associated with CFDA number 12.420.

What category does this funding opportunity fall under?

It falls under the Science and Technology and other Research and Development category.

When was this funding opportunity posted?

The opportunity was posted on May 5, 2016.

What was the application closing date for this opportunity?

The original and current closing date listed is October 26, 2016.

How many awards were expected?

The posting indicates an expectation of eight awards.

Is there a maximum award amount (ceiling) stated in the provided information?

An award ceiling field is shown in the posting, but no specific ceiling amount is provided in the supplied excerpt.

Who is eligible to apply?

Eligibility is described as unrestricted (open to any type of entity), subject to any additional eligibility clarifications that may appear in the full text of the announcement.

What is the key theme applicants should emphasize in their proposals?

Based on the information provided, applicants should emphasize (1) direct alignment to at least one FY16 PRMRP Topic Area, (2) a strong case for meaningful clinical impact, (3) readiness for rapid start-up and execution, and (4) clear relevance to the health care needs of Service members, Veterans, and/or other DoD beneficiaries (even if the enrolled population is civilian).