Opportunity Information: Apply for W81XWH 20 PRORP CTA
The DoD Peer Reviewed Orthopaedic Research Program (PRORP) Clinical Trial Award (CTA) is a Department of Defense funding opportunity meant to move quickly from promising ideas to real-world testing in people, specifically through human clinical trials. It focuses on interventions that could substantially improve outcomes for Service Members and Veterans with combat-related orthopaedic injuries, as well as non-battle orthopaedic injuries that still have a major effect on unit readiness and the ability to return to duty or work. A central theme is practicality and impact: applicants are pushed to show how their trial could support care closer to the point of injury and/or shorten the time it takes for injured personnel to recover and resume their roles.
This award is strictly for clinical trials, not general clinical research. In other words, the work must involve prospectively assigning human participants to one or more interventions (including placebo or control conditions when relevant) to measure biomedical or behavioral health-related outcomes. The mechanism can support a wide range of trial sizes and maturity levels, from small early-stage studies (such as pilot studies, first-in-human efforts, or Phase 0 style feasibility trials) to larger trials designed to determine efficacy in appropriate patient populations. The interventions themselves can also vary widely, including evaluation of new or improved products, drugs or biologics, medical devices, clinical guidance, and emerging technologies or approaches, as long as the project is truly a clinical trial and remains aligned with orthopaedic injury priorities tied to military needs. The CTA is explicitly contrasted with the PRORP Clinical Translational Research Award (CTRA): the CTRA can fund broader clinical research, while the CTA is limited to clinical trials only.
A notable feature is an added “Rehabilitation Option” tied to the Translation of Early Findings - Soft Tissue Trauma focus area. Applications in that area can request a higher funding level to support interdisciplinary projects that deliberately integrate surgical and rehabilitation strategies into a single, cohesive plan. The intent is to go beyond parallel efforts and instead combine approaches so the integrated strategy improves outcomes more than either component would alone. Surgical strategies can include reconstruction/repair and/or the use of biologics, pharmaceuticals, or devices aimed at restoring the native structure and function of traumatically injured tissues. Rehabilitation strategies are framed around restoring function and independence after injury or illness. Applicants pursuing this option must spell out the rehabilitation strategy and the relevant standard of care, and they are strongly encouraged to follow patients across the full continuum of care. Collaboration is not optional here: the team must include at least one investigator with orthopaedic rehabilitation expertise and at least one orthopaedic/trauma care clinician (credentialed and actively practicing), and letters of collaboration from both the rehab specialist and the surgeon/trauma clinician are required.
The opportunity places heavy emphasis on readiness to execute. Preliminary data that directly supports the proposed trial is required, and the trial is expected to start within 12 months of the award date, which signals that the program is prioritizing projects that are already well-developed rather than early brainstorming. Applicants need to show that the intervention has a strong scientific rationale grounded in a thoughtful review of existing literature, and they are expected to articulate objectives and endpoints that are clearly defined and aligned with Good Clinical Practice (GCP). Practical trial operations matter just as much as scientific novelty: proposals must demonstrate access to an adequate patient population, explain how recruitment targets will be met, and discuss how existing standards of care might affect enrollment or interpretation of results. The program also expects a serious statistical foundation, including a power analysis, sample size justification, and appropriate statistical expertise on the team.
Because many orthopaedic trials involve regulated products, the announcement lays out regulatory expectations clearly. 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 a device is being studied, an Investigational Device Exemption (IDE) may be required under 21 CFR 812, or the applicant must document why an IDE is not required or why an abbreviated IDE applies. For international trial sites, the relevant host-country regulatory submissions are also required when applicable. A major compliance pressure point is timing: if an IND, IDE, and/or international regulatory application is required, it must be submitted within 6 months of the award date, and the government explicitly reserves the right to withdraw funding if required submissions are not made on time. Applicants are also expected to show they can obtain and supply the investigational product for the duration of the study, with documentation of quality and stability consistent with applicable FDA manufacturing expectations (such as GMP and other quality system standards, depending on product type and stage). The announcement also asks teams to reflect experience working with the FDA, including prior submissions when relevant, which reinforces that the program is looking for teams capable of navigating regulated clinical development.
Operational oversight and transparency are built into the award requirements. Awardees will work with CDMRP and USAMRAA to set human subject recruitment milestones, and continued support depends on meeting those milestones satisfactorily. Applications are expected to include robust infrastructure plans: data management (including use of appropriate databases to protect data integrity and, when FDA-regulated, use of 21 CFR 11-compliant systems and appropriate data standards), safety management and pharmacovigilance approaches as applicable, and a clinical monitoring plan for GCP compliance. The program also expects applicants to include dedicated study coordination capacity to manage IRB and other regulatory approvals, coordinate multi-site activities, and drive participant accrual. On the public accountability side, funded studies must be registered on ClinicalTrials.gov prior to starting, and awardees must post the IRB-approved informed consent form on a publicly available federal website as required under 32 CFR 219.
Another consistent theme is what happens after the trial ends. Applicants must include a transition plan describing how the product or approach will move forward after the CTA period, whether that means progressing to the next phase of clinical trials, securing follow-on funding, or moving toward broader implementation or commercialization. The application also needs to show strong institutional support, and when relevant, a clear commitment and capability to serve as the FDA regulatory sponsor and fulfill sponsor responsibilities (for example, those described in 21 CFR 312, Subpart D).
In terms of funding structure and scale, awards are made as assistance agreements, meaning they can be issued either as grants or cooperative agreements depending on how much involvement the DoD expects to have during project performance. Total costs over the entire period of performance are capped at $2.25 million for Funding Level 1 and $2.75 million for Funding Level 2 (the level associated with the Rehabilitation Option). For FY20, the program expected to allocate about $9 million to fund roughly four Level 1 awards and about $5.5 million to fund roughly two Level 2 awards, for an anticipated total of about six awards, although final funding depends on federal funds availability and the outcomes of scientific and programmatic review. Eligibility is listed as unrestricted (open to many entity types, subject to any specific clarifications in the announcement). The opportunity was managed by the Department of Defense, Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA), under Funding Opportunity Number W81XWH-20-PRORP-CTA, originally posted March 16, 2020, with an original closing date of September 10, 2020, and awards planned no later than September 30, 2021. The FY20 funds associated with these awards were anticipated to remain available for use until September 30, 2026, which sets an outer boundary on the life of the funding even though the project period and expenditure timing are governed by the award’s negotiated terms.Apply for W81XWH 20 PRORP CTA
- 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 "DoD Peer Reviewed Orthopaedic, Clinical Trial Award" 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 Mar 16, 2020.
- Applicants must submit their applications by Sep 10, 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 6 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.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
FAQs: DoD PRORP Clinical Trial Award (CTA) - W81XWH-20-PRORP-CTA
What is the PRORP Clinical Trial Award (CTA)?
The PRORP Clinical Trial Award (CTA) is a Department of Defense funding opportunity that supports human clinical trials designed to move quickly from promising orthopaedic ideas to real-world testing in people. The goal is to substantially improve outcomes for Service Members and Veterans with combat-related orthopaedic injuries and non-battle orthopaedic injuries that affect unit readiness and return to duty/work.
What kinds of problems is the CTA trying to solve?
The CTA emphasizes practical, high-impact trials that can support care closer to the point of injury and/or shorten recovery time so injured personnel can resume their roles sooner. It prioritizes orthopaedic injury needs tied to military readiness and recovery.
Is this award for any type of clinical research?
No. This mechanism is strictly for clinical trials, not general clinical research. Projects must meet the definition of a clinical trial by prospectively assigning human participants to one or more interventions (including placebo or control, when relevant) to measure biomedical or behavioral health-related outcomes.
How does the CTA differ from the PRORP Clinical Translational Research Award (CTRA)?
The CTA is limited to clinical trials only, while the CTRA can support broader clinical research. If a project is not a clinical trial (as defined in the announcement), it would not fit the CTA.
What types of clinical trials can be supported?
The CTA can support a range of trial sizes and maturity levels, including smaller early-stage studies (such as pilot studies, first-in-human efforts, or Phase 0-style feasibility trials) and larger trials designed to determine efficacy in appropriate patient populations.
What kinds of interventions are allowed?
Interventions can include new or improved products, drugs or biologics, medical devices, clinical guidance, and emerging technologies or approaches, as long as the effort is a true clinical trial and aligns with orthopaedic injury priorities tied to military needs.
What is the "Rehabilitation Option" and when does it apply?
The Rehabilitation Option is an added option tied to the Translation of Early Findings - Soft Tissue Trauma focus area. It allows applications in that area to request a higher funding level to support interdisciplinary projects that integrate surgical and rehabilitation strategies into one cohesive plan.
What does it mean to integrate surgical and rehabilitation strategies (Rehabilitation Option)?
It means the surgical and rehabilitation components should not be parallel, loosely connected efforts. The application is expected to present an intentionally combined strategy where the integration improves outcomes more than either component would alone.
What are examples of surgical and rehabilitation strategies described for the Rehabilitation Option?
Surgical strategies may include reconstruction/repair and/or the use of biologics, pharmaceuticals, or devices intended to restore native structure and function of traumatically injured tissues. Rehabilitation strategies are framed around restoring function and independence after injury or illness.
Are there team requirements for the Rehabilitation Option?
Yes. The project team must include (1) at least one investigator with orthopaedic rehabilitation expertise and (2) at least one orthopaedic/trauma care clinician who is credentialed and actively practicing. Letters of collaboration from both the rehabilitation specialist and the surgeon/trauma clinician are required.
Does the CTA require preliminary data?
Yes. Preliminary data that directly supports the proposed trial is required, reflecting the program emphasis on readiness to execute.
How soon is the clinical trial expected to begin after an award is made?
The trial is expected to start within 12 months of the award date, indicating that the program is focused on well-developed trials rather than early-stage brainstorming.
What are expectations for the scientific rationale and trial endpoints?
Applicants are expected to provide a strong scientific rationale grounded in a thoughtful review of the existing literature and to articulate objectives and endpoints that are clearly defined and aligned with Good Clinical Practice (GCP).
What operational details does the program expect in the application?
Applications are expected to demonstrate access to an adequate patient population, explain how recruitment targets will be met, and discuss how existing standards of care might affect enrollment or interpretation of results.
What statistical requirements are emphasized?
The program expects a serious statistical foundation, including a power analysis, sample size justification, and appropriate statistical expertise on the team.
When might an IND be required, and what rule is 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.
When might an IDE be required, and what rule is referenced?
If a device is being studied, an Investigational Device Exemption (IDE) may be required under 21 CFR 812. If an IDE is not required (or an abbreviated IDE applies), the applicant must document why.
Are there regulatory expectations for international trial sites?
Yes. For international trial sites, relevant host-country regulatory submissions are required when applicable.
What is the deadline for required IND/IDE/international regulatory submissions after award?
If an IND, IDE, and/or international regulatory application is required, it must be submitted within 6 months of the award date.
What happens if required regulatory submissions are not made on time?
The government explicitly reserves the right to withdraw funding if required submissions are not made within the stated timeline.
Do applicants need to show they can supply the investigational product?
Yes. Applicants are expected to show they can obtain and supply the investigational product for the duration of the study and provide documentation of quality and stability consistent with applicable FDA manufacturing expectations (such as GMP and other quality system standards, depending on product type and stage).
Does the opportunity consider a team's experience with FDA interactions?
Yes. The announcement asks teams to reflect experience working with the FDA, including prior submissions when relevant, reinforcing the expectation that teams can navigate regulated clinical development.
Will awardees have recruitment milestones they must meet?
Yes. Awardees will work with CDMRP and USAMRAA to set human subject recruitment milestones, and continued support depends on meeting those milestones satisfactorily.
What data management expectations are described?
Applications are expected to include data management plans that protect data integrity and, when FDA-regulated, use 21 CFR 11-compliant systems and appropriate data standards.
Are safety management and monitoring plans required?
Yes. The opportunity expects safety management and pharmacovigilance approaches as applicable, and a clinical monitoring plan to support GCP compliance.
Is dedicated study coordination capacity expected?
Yes. The program expects dedicated study coordination to manage IRB and other regulatory approvals, coordinate multi-site activities, and drive participant accrual.
Are there public registration and transparency requirements?
Yes. Funded studies must be registered on ClinicalTrials.gov prior to starting. Awardees must also post the IRB-approved informed consent form on a publicly available federal website as required under 32 CFR 219.
Is a transition plan required, and what should it cover?
Yes. Applicants must include a transition plan describing how the product or approach will move forward after the CTA period, such as progressing to the next phase of clinical trials, securing follow-on funding, or moving toward broader implementation or commercialization.
Is institutional support addressed?
Yes. The application needs to show strong institutional support.
What does the announcement say about being an FDA regulatory sponsor?
When relevant, applications should show a clear commitment and capability to serve as the FDA regulatory sponsor and fulfill sponsor responsibilities (for example, those described in 21 CFR 312, Subpart D).
What type of award instrument is used?
Awards are made as assistance agreements, meaning they can be issued either as grants or cooperative agreements depending on how much involvement the DoD expects to have during project performance.
What are the maximum funding caps?
Total costs over the entire period of performance are capped at $2.25 million for Funding Level 1 and $2.75 million for Funding Level 2 (the level associated with the Rehabilitation Option).
How much funding and how many awards were anticipated for FY20?
For FY20, the program expected to allocate about $9 million for roughly four Funding Level 1 awards and about $5.5 million for roughly two Funding Level 2 awards, for an anticipated total of about six awards. Final funding depends on federal funds availability and the outcomes of scientific and programmatic review.
Who is eligible to apply?
Eligibility is listed as unrestricted (open to many entity types), subject to any specific clarifications in the announcement.
Which agencies manage this opportunity?
The opportunity is managed by the Department of Defense, Department of the Army, U.S. Army Medical Research Acquisition Activity (USAMRAA), under the PRORP program.
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is W81XWH-20-PRORP-CTA.
When was it posted and when did it close?
It was originally posted March 16, 2020, with an original closing date of September 10, 2020.
When were awards planned to be made?
Awards were planned no later than September 30, 2021.
How long were the FY20 funds anticipated to remain available?
The FY20 funds associated with these awards were anticipated to remain available for use until September 30, 2026, which sets an outer boundary on the life of the funding (while project period and expenditure timing are governed by the negotiated award terms).
Browse more opportunities from the same category: Science and Technology and other Research and Development
Next opportunity: Sustainable Materials Management Grants
Previous opportunity: DRL AGOA Civil Society Network Support
Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for W81XWH 20 PRORP CTA
Applicants also applied for:
Applicants who have applied for this opportunity (W81XWH 20 PRORP CTA) also looked into and applied for these:
| Funding Opportunity |
|---|
| Scientific Discovery through Advanced Computing (SciDAC) Institutes Apply for DE FOA 0002223 Funding Number: DE FOA 0002223 Agency: Department of Energy - Office of Science, Office of Science Category: Science and Technology and other Research and Development Funding Amount: $30,000,000 |
| Assistive Technology Alternative Financing Program Apply for HHS 2020 ACL CIP ATTF 0426 Funding Number: HHS 2020 ACL CIP ATTF 0426 Agency: Department of Health and Human Services, Administration for Community Living Category: Science and Technology and other Research and Development Funding Amount: $700,000 |
| DoD Tick-Borne Disease, Career Development Award Apply for W81XWH 20 TBDRP CDA Funding Number: W81XWH 20 TBDRP CDA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Tick-Borne Disease, Idea Development Award Apply for W81XWH 20 TBDRP IDA Funding Number: W81XWH 20 TBDRP IDA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Prostate Cancer, Physician Research Award Apply for W81XWH 20 PCRP PRA Funding Number: W81XWH 20 PCRP PRA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Prostate Cancer, Early Investigator Research Award Apply for W81XWH 20 PCRP EIRA Funding Number: W81XWH 20 PCRP EIRA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Disability and Rehabilitation Research Projects (DRRP) Program: Technology for Expressive Communication Apply for HHS 2020 ACL NIDILRR DPCP 0394 Funding Number: HHS 2020 ACL NIDILRR DPCP 0394 Agency: Department of Health and Human Services, Administration for Community Living Category: Science and Technology and other Research and Development Funding Amount: $500,000 |
| Cooperative Ecosystem Studies Unit, Rocky Mountain CESU Apply for G20AS00043 Funding Number: G20AS00043 Agency: Department of the Interior, U. S. Geological Survey Category: Science and Technology and other Research and Development Funding Amount: $45,676 |
| DoD Spinal Cord Injury, Translational Research Award Apply for W81XWH 20 SCIRP TRA Funding Number: W81XWH 20 SCIRP TRA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Spinal Cord Injury, Investigator- Initiated Research Award Apply for W81XWH 20 SCIRP IIRA Funding Number: W81XWH 20 SCIRP IIRA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Spinal Cord Injury, Clinical Trial Award Apply for W81XWH 20 SCIRP CTA Funding Number: W81XWH 20 SCIRP CTA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Research and Development in Forensic Science for Criminal Justice Purposes, Fiscal Year 2020 Apply for NIJ 2020 17294 Funding Number: NIJ 2020 17294 Agency: Department of Justice, National Institute of Justice Category: Science and Technology and other Research and Development Funding Amount: $20,000,000 |
| Air Force Fiscal Year 2021 Young Investigator Research Program (YIP) Apply for FOA AFRL AFOSR 2020 0003 Funding Number: FOA AFRL AFOSR 2020 0003 Agency: Department of Defense, Air Force Office of Scientific Research Category: Science and Technology and other Research and Development Funding Amount: $450,000 |
| ROSES 2020: Ocean Biology and Biogeochemistry Apply for NNH20ZDA001N OBB Funding Number: NNH20ZDA001N OBB Agency: National Aeronautics and Space Administration, NASA Headquarters Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Lung Cancer, Clinical Translational Research Partnership Award Apply for W81XWH 20 LCRP CTRPA Funding Number: W81XWH 20 LCRP CTRPA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Lung Cancer, Career Development Award Apply for W81XWH 20 LCRP CDA Funding Number: W81XWH 20 LCRP CDA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| Rehabilitation Research and Training Center (RRTC) on Health and Function of People with Psychiatric Disabilities Apply for HHS 2020 ACL NIDILRR RTHF 0389 Funding Number: HHS 2020 ACL NIDILRR RTHF 0389 Agency: Department of Health and Human Services, Administration for Community Living Category: Science and Technology and other Research and Development Funding Amount: $875,000 |
| DoD Peer Reviewed Cancer Research, Virtual Cancer Center Director Award Apply for W81XWH 20 PRCRP VCCDA Funding Number: W81XWH 20 PRCRP VCCDA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Peer Reviewed Cancer Research, Behavioral Health Science Award Apply for W81XWH 20 PRCRP BHSA Funding Number: W81XWH 20 PRCRP BHSA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Peer Reviewed Cancer Research, Career Development Award Apply for W81XWH 20 PRCRP CDA Funding Number: W81XWH 20 PRCRP CDA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Inside Our Applicants Portal
Access Applicants Portal
- Grants Repository - Access current and historic funding opportunities with ease. Thousands of funding opportunities are published every week. We can help you sort through the database and find the eligible ones to apply for.
- Applicant Video Guides - The grant application process can be challenging to follow. We can help you with intuitive video guides to speed up the process and eliminate errors in submissions.
- Grant Proposal Wizard - We have developed a network of private funding organizations and investors across the United States. We can reach out and submit your proposal to these contacts to maximize your chances of getting the funding you need.
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Learn More
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "W81XWH 20 PRORP CTA", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.