Opportunity Information: Apply for W81XWH 20 PRMRP CTA COV
The CDMRP PRMRP Clinical Trial Award for Emerging Viral Diseases and Respiratory Health is a Department of Defense (DoD) funding opportunity intended to move quickly on human clinical research that can make a meaningful difference in priority areas tied to Emerging Viral Diseases and Respiratory Health. Run through the U.S. Army Medical Research Acquisition Activity (USAMRAA) under the Congressionally Directed Medical Research Programs (CDMRP), the award is built for studies that are ready to be tested in people and that have a clear path to impact within one or more Focus Areas listed in the funding announcement for FY20. The central aim is speed and relevance: getting well-justified clinical trials underway without spending the award on earlier-stage animal or purely preclinical work.
This mechanism specifically supports clinical trials that prospectively assign one or more human subjects to one or more interventions in order to measure biomedical or behavioral health outcomes. In practice, that means the project must involve an intervention (or interaction) delivered to participants, potentially including a placebo or other control, and then the study team evaluates how that intervention affects outcomes in the participants. The announcement emphasizes that the outcomes should represent direct effects of the intervention on the subjects. The term "human subjects" is used to describe the individuals who will be recruited for or enrolled in the proposed trial, and applicants are directed to consult the Human Subject Resource Document available through eBRAP for additional guidance and expectations.
The types of interventions and trial concepts the program is willing to support are broad, as long as they align with the focus areas and are appropriate for a clinical trial framework. Examples explicitly called out include promising new products, pharmacologic agents such as drugs or biologics, devices, clinical guidance, and emerging approaches or technologies. The program is also flexible on trial stage and scale. It can support smaller, early proof-of-concept efforts such as pilot studies, first-in-human studies, or Phase 0 work meant to demonstrate feasibility or generate the information needed to design a more definitive study. At the other end of the spectrum, it can also support larger trials designed to determine efficacy in relevant patient populations, provided the project is positioned to execute and deliver interpretable results.
A key constraint is that the award funds must be used to support a clinical trial and cannot be used for animal studies. Applicants who are still at the preclinical stage are advised to look to other FY20 PRMRP program announcements rather than this clinical trial-specific mechanism. In other words, the program is not meant to bridge from bench to bedside in the same award; it is meant to pay for the bedside trial itself.
Administratively, the opportunity is listed as discretionary funding and may be offered as either a grant or a cooperative agreement, under the Science and Technology and other Research and Development category (CFDA 12.420). Eligibility is described as unrestricted, meaning it is broadly open to applicant organizations, subject to any additional eligibility clarifications contained in the full announcement. The opportunity number is W81XWH-20-PRMRP-CTA-COV, with an original closing date of June 22, 2020, and an estimated five awards. The notice lists an award ceiling of 0, which typically indicates that the maximum amount is not specified in the summary field and that applicants should rely on the full funding announcement for budget limits, expectations, and any caps that may apply.Apply for W81XWH 20 PRMRP CTA COV
- The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "CDMRP PRMRP Clinical Trial Award for Emerging Viral Diseases and Respiratory Health" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
- This funding opportunity was created on Apr 08, 2020.
- Applicants must submit their applications by Jun 22, 2020. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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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FAQs: CDMRP PRMRP Clinical Trial Award for Emerging Viral Diseases and Respiratory Health (W81XWH-20-PRMRP-CTA-COV)
What is this funding opportunity?
The CDMRP PRMRP Clinical Trial Award for Emerging Viral Diseases and Respiratory Health is a Department of Defense (DoD) funding opportunity intended to move quickly on human clinical research that can make a meaningful difference in priority areas tied to Emerging Viral Diseases and Respiratory Health.
Which DoD offices run or administer this award?
The award is run through the U.S. Army Medical Research Acquisition Activity (USAMRAA) under the Congressionally Directed Medical Research Programs (CDMRP).
What is the main goal or emphasis of this award mechanism?
The central aim is speed and relevance: launching well-justified clinical trials in humans that have a clear path to impact within one or more Focus Areas identified in the FY20 funding announcement, without using the award for earlier-stage animal or purely preclinical work.
What kind of research does this award specifically support?
This mechanism specifically supports clinical trials that prospectively assign one or more human subjects to one or more interventions to measure biomedical or behavioral health outcomes.
What qualifies as a "clinical trial" under this announcement?
A qualifying project must include an intervention (or interaction) delivered to participants, potentially including a placebo or other control, and must evaluate direct effects of that intervention on outcomes in the participants.
Does the clinical trial need to include a control group or placebo?
The description allows for placebo or other control, but it does not state that a control group is required in every case. The key requirement described is prospective assignment of human subjects to one or more interventions and measurement of outcomes.
What are "human subjects" in the context of this award?
"Human subjects" refers to the individuals who will be recruited for or enrolled in the proposed clinical trial.
Is there additional guidance for human subjects research expectations?
Yes. Applicants are directed to consult the Human Subject Resource Document available through eBRAP for additional guidance and expectations.
What types of interventions are eligible to be tested?
The program describes a broad range of intervention types, as long as they align with the stated Focus Areas and fit a clinical trial framework. Examples explicitly mentioned include promising new products, pharmacologic agents such as drugs or biologics, devices, clinical guidance, and emerging approaches or technologies.
Can this award support early-stage clinical studies (like pilot or first-in-human work)?
Yes. The program can support smaller, early proof-of-concept efforts such as pilot studies, first-in-human studies, or Phase 0 work intended to demonstrate feasibility or generate information needed to design a more definitive study.
Can this award support larger clinical trials?
Yes. It can also support larger trials designed to determine efficacy in relevant patient populations, as long as the project is positioned to execute and deliver interpretable results.
Are animal studies allowed under this award?
No. A key constraint is that award funds cannot be used for animal studies. The funding is meant to support a clinical trial in humans.
Can preclinical or purely bench research be included as part of the project?
The opportunity emphasizes that it is not intended for purely preclinical work and is meant to fund the clinical trial itself rather than bridging from bench to bedside within the same award.
If a project is still preclinical, is this the right mechanism to apply to?
No. Applicants who are still at the preclinical stage are advised to look to other FY20 PRMRP program announcements rather than this clinical trial-specific mechanism.
What topic areas must the study align with?
The study must have a clear path to impact within one or more Focus Areas listed in the FY20 funding announcement for Emerging Viral Diseases and Respiratory Health.
What is the opportunity number for this funding announcement?
The opportunity number is W81XWH-20-PRMRP-CTA-COV.
What is the CFDA number and category listed for this opportunity?
The opportunity is listed under CFDA 12.420 and categorized under Science and Technology and other Research and Development.
Is this considered discretionary funding?
Yes. The opportunity is listed as discretionary funding.
What type of award instrument will be used?
The notice states that awards may be offered as either a grant or a cooperative agreement.
Who is eligible to apply?
Eligibility is described as unrestricted, meaning it is broadly open to applicant organizations, subject to any additional eligibility clarifications contained in the full announcement.
How many awards are expected to be made?
The notice estimates approximately five awards.
What was the original closing date for this opportunity?
The original closing date listed is June 22, 2020.
Is there a maximum award amount (award ceiling)?
The notice lists an award ceiling of 0, which typically indicates that the maximum amount is not specified in the summary field. Applicants are expected to rely on the full funding announcement for budget limits, expectations, and any caps that may apply.
Where should applicants look for detailed budget limits and caps?
Budget limits, expectations, and any caps are expected to be specified in the full funding announcement rather than the summary field that shows an award ceiling of 0.
What does the announcement say about the desired impact timeline?
It stresses moving quickly on human clinical research and getting clinical trials underway with a clear path to meaningful impact in the stated Focus Areas.
Does this award support studies that are already ready to be tested in people?
Yes. The award is described as being built for studies that are ready to be tested in people and positioned to execute a clinical trial with interpretable results.
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| DoD Melanoma, Translational Research Award Apply for W81XWH 20 MRP TRA Funding Number: W81XWH 20 MRP TRA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
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