Opportunity Information: Apply for W81XWH 20 PRORP CTRA
The DoD Peer Reviewed Orthopaedic, Clinical Translational Research Award (CTRA) is a funding mechanism under the Congressionally Directed Medical Research Programs (CDMRP) Peer Reviewed Orthopaedic Research Program (PRORP), managed through the U.S. Army Medical Research Acquisition Activity (USAMRAA). It is designed to move promising orthopaedic injury research into real-world clinical use by supporting high-impact, clinical translational projects that can influence near-term and long-term standards of care and help build evidence-based guidelines relevant to military personnel, Veterans, and civilian patients with orthopaedic injuries. Since its first offering in FY2016, the program had received 57 applications with 12 recommended for funding, reflecting a relatively selective portfolio focused on practical clinical relevance.
A central emphasis of the FY2020 CTRA is translation: taking current or emerging techniques, diagnostics, treatments, rehabilitation strategies, or prevention approaches and testing or evaluating them in clinical settings where they can better serve military patients. Applicants are expected to consider outcomes that matter in day-to-day life, such as health status, functional recovery, quality of life, return to duty, and return to work. Another stated goal is comparative and decision-support value, meaning the research should help identify what works best for diagnosis, treatment, rehab, and prevention so that patients, clinicians, caregivers, and policymakers can make better informed choices.
This opportunity is broader than a traditional clinical trial-only mechanism. The CTRA differs from the PRORP Clinical Trial Award (CTA) because it can fund clinical research that may not yet be ready for a full-scale randomized controlled trial, while still allowing interventional studies and even small pilot clinical trials involving human subjects. Some retrospective data analysis can be included, but the program explicitly does not support projects that are purely retrospective or only based on databases. The work must be clinical in nature and must involve human-focused clinical research; animal research is not allowed under this award. Investigators who need animal studies are directed to a different PRORP mechanism (the Applied Research Award).
Because many translational orthopaedic projects involve regulated drugs or devices, the announcement lays out clear regulatory expectations. If a study uses a drug that is not FDA-approved for the proposed use, an Investigational New Drug (IND) application may be required, and the awardee must either document that an IND is not required (via the IRB of record or FDA) or submit the IND to FDA within 12 months of the award date. Similar requirements apply to investigational devices through the Investigational Device Exemption (IDE) process (including documentation if an IDE is not required or qualifies for an abbreviated IDE). If an investigational product trial is conducted internationally, the awardee must also submit applications to relevant national regulatory agencies within the same 12-month window. Importantly, the government reserves the right to withdraw funding if required IND/IDE or international regulatory submissions are not made within 12 months.
The program places heavy weight on feasibility and rigorous clinical execution. Applications must include preliminary data that directly supports the proposed clinical research. They must show a sound scientific rationale grounded in careful literature analysis, as well as demonstrated access to an appropriate patient population that can realistically meet accrual targets. Applicants are expected to explain recruitment and enrollment strategies, address how existing standards of care could affect enrollment or interpretation, and show they have access to needed study materials (such as drugs, devices, or other intervention components) for the full study duration. Where applicable, product quality, stability, and manufacturing controls should align with FDA expectations (for example, GMP or Quality System Regulation principles).
From a design and operations standpoint, proposals are expected to look like well-run clinical studies. The announcement calls for clear objectives and well-justified endpoints/outcome measures, adherence to Good Clinical Practice (GCP), and a complete statistical plan that includes appropriate statistical expertise and power/sample size justification tied to the study aims. It also requires a data management plan and use of an appropriate database to protect integrity of the data; if the study is FDA-regulated, the database must be 21 CFR Part 11 compliant and use appropriate data standards. Applicants must also address participant safety and oversight through a safety management/pharmacovigilance plan when applicable, and a clinical monitoring plan to ensure GCP compliance. Operationally, the program expects a dedicated study coordinator (or coordinators) to manage IRB and other regulatory workflows, coordinate multi-site activities if applicable, and support participant accrual.
Military and Veteran relevance is a required thread throughout the application. Every proposal must clearly articulate why the work matters to military and/or Veteran populations affected by orthopaedic injury. While including active duty Service members or Veterans as study participants is encouraged, it is not mandatory; what matters is a credible and explicit connection to orthopaedic problems that affect readiness, recovery, and long-term function. Collaboration with military and VA researchers or clinicians is encouraged as another way to strengthen relevance and implementation potential.
The award also pushes applicants to think beyond the study itself and toward real-world impact. A transition plan is required, describing how the intervention, product, or clinical approach will move to the next clinical phase and/or toward broader delivery or commercialization after the CTRA is completed. The application should also demonstrate strong institutional support and, when applicable, a commitment to serve as the FDA regulatory sponsor, taking on sponsor responsibilities described in federal regulations (for example, 21 CFR 312 for drugs).
For projects that meet the definition of a clinical trial (prospective assignment of human subjects to interventions to evaluate effects on health-related outcomes), additional federal transparency requirements apply. Funded clinical trials 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 by federal human subjects regulations.
In terms of funding structure, awards are made as assistance agreements, meaning they may be issued either as grants or cooperative agreements depending on the anticipated level of DoD involvement during performance. The mechanism allows up to $1.5 million in total costs per award over the full period of performance. For FY2020, the program expected to allocate about $6 million total to fund roughly four awards, with funding dependent on federal availability and on scientific and programmatic review outcomes. The opportunity (Funding Opportunity Number W81XWH-20-PRORP-CTRA; CFDA 12.420) was open to unrestricted applicant types (subject to any eligibility clarifications in the full announcement). The original application closing date was September 10, 2020, and awards were expected to be made no later than September 30, 2021. Funds were anticipated to come from FY2020 appropriations and were expected to remain available for use through September 30, 2026, consistent with the fiscal lifecycle of those funds.
Overall, the CTRA is best understood as a clinically grounded translational bridge: it supports disciplined, human-centered orthopaedic research that is more advanced than early exploratory work but not necessarily ready for a large definitive randomized trial, with strong expectations around feasibility, recruitment, regulatory readiness, data quality, and a credible path to changing clinical practice for military and Veteran orthopaedic care.Apply for W81XWH 20 PRORP CTRA
- 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 Translational Research 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 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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Frequently Asked Questions (FAQs): DoD Peer Reviewed Orthopaedic, Clinical Translational Research Award (CTRA)
1. What is the PRORP Clinical Translational Research Award (CTRA)?
The CTRA is a funding mechanism within the Congressionally Directed Medical Research Programs (CDMRP) Peer Reviewed Orthopaedic Research Program (PRORP), managed through the U.S. Army Medical Research Acquisition Activity (USAMRAA). It supports high-impact, clinically grounded translational orthopaedic research intended to move promising approaches into real-world clinical use and influence standards of care and evidence-based guidelines relevant to military personnel, Veterans, and civilian patients with orthopaedic injuries.
2. What is the main purpose or emphasis of the FY2020 CTRA?
The central emphasis is translation: taking current or emerging techniques, diagnostics, treatments, rehabilitation strategies, or prevention approaches and testing or evaluating them in clinical settings so they can better serve patients, including military populations.
3. What kinds of outcomes does the CTRA expect studies to focus on?
Applicants are expected to consider outcomes that matter in day-to-day life and real clinical decision-making, including health status, functional recovery, quality of life, return to duty, and return to work.
4. Does the CTRA aim to support comparative or decision-support research?
Yes. A stated goal is comparative and decision-support value, meaning the research should help identify what works best for diagnosis, treatment, rehabilitation, and prevention so that patients, clinicians, caregivers, and policymakers can make better-informed choices.
5. How is the CTRA different from the PRORP Clinical Trial Award (CTA)?
The CTRA is broader than a traditional clinical trial-only mechanism. It can fund clinical research that may not yet be ready for a full-scale randomized controlled trial while still allowing interventional studies and even small pilot clinical trials involving human subjects.
6. Are small pilot clinical trials allowed under the CTRA?
Yes. The CTRA can support interventional studies, including small pilot clinical trials involving human subjects, as part of clinically translational work.
7. Are purely retrospective studies allowed?
No. Some retrospective data analysis can be included, but the program explicitly does not support projects that are purely retrospective or only based on databases.
8. Does the proposed work have to be clinical and involve human subjects?
Yes. The work must be clinical in nature and must involve human-focused clinical research.
9. Is animal research allowed under the CTRA?
No. Animal research is not allowed under this award. Investigators needing animal studies are directed to a different PRORP mechanism (the Applied Research Award).
10. What regulatory requirements apply if the project involves a drug that is not FDA-approved for the proposed use?
An Investigational New Drug (IND) application may be required. The awardee must either document that an IND is not required (via the IRB of record or FDA) or submit the IND to FDA within 12 months of the award date.
11. What regulatory requirements apply if the project involves an investigational device?
Similar expectations apply through the Investigational Device Exemption (IDE) process. The awardee must provide documentation if an IDE is not required or qualifies for an abbreviated IDE, or submit the IDE as needed within 12 months of the award date.
12. What happens if required IND/IDE submissions are not made on time?
The government reserves the right to withdraw funding if required IND/IDE (or international regulatory) submissions are not made within 12 months of the award date.
13. What if the investigational product trial is conducted internationally?
If an investigational product trial is conducted internationally, the awardee must also submit applications to the relevant national regulatory agencies within the same 12-month window.
14. Is preliminary data required?
Yes. Applications must include preliminary data that directly supports the proposed clinical research.
15. What does the program expect regarding feasibility and recruitment?
Applications must demonstrate access to an appropriate patient population that can realistically meet accrual targets. Applicants are expected to explain recruitment and enrollment strategies and address how existing standards of care could affect enrollment or interpretation.
16. Do applicants need to show access to study materials (drugs/devices/interventions)?
Yes. Applicants must show they have access to needed study materials (such as drugs, devices, or other intervention components) for the full study duration.
17. Are there expectations related to product quality or manufacturing controls?
Yes, where applicable. Product quality, stability, and manufacturing controls should align with FDA expectations (for example, GMP or Quality System Regulation principles).
18. What are the expectations for clinical study design and conduct?
The announcement calls for clear objectives, well-justified endpoints/outcome measures, adherence to Good Clinical Practice (GCP), and rigorous clinical execution consistent with well-run clinical studies.
19. Is a statistical plan required?
Yes. A complete statistical plan is required, including appropriate statistical expertise and power/sample size justification tied to the study aims.
20. Is a data management plan required?
Yes. The program requires a data management plan and use of an appropriate database to protect the integrity of the data.
21. Are there specific database requirements for FDA-regulated studies?
Yes. If the study is FDA-regulated, the database must be 21 CFR Part 11 compliant and use appropriate data standards.
22. Are participant safety and oversight plans required?
Yes, when applicable. Applicants must address participant safety and oversight through a safety management/pharmacovigilance plan and include a clinical monitoring plan to ensure GCP compliance.
23. Does the application need to include study coordination capacity?
Yes. Operationally, the program expects a dedicated study coordinator (or coordinators) to manage IRB and other regulatory workflows, coordinate multi-site activities if applicable, and support participant accrual.
24. Is military and Veteran relevance required?
Yes. Every proposal must clearly articulate why the work matters to military and/or Veteran populations affected by orthopaedic injury.
25. Do studies have to include active duty Service members or Veterans as participants?
No. Including active duty Service members or Veterans is encouraged but not mandatory. What matters is a credible and explicit connection to orthopaedic problems that affect readiness, recovery, and long-term function.
26. Is collaboration with military or VA partners encouraged?
Yes. Collaboration with military and VA researchers or clinicians is encouraged to strengthen relevance and implementation potential.
27. Is a transition plan required?
Yes. A transition plan is required describing how the intervention, product, or clinical approach will move to the next clinical phase and/or toward broader delivery or commercialization after the CTRA is completed.
28. What does the opportunity say about FDA regulatory sponsor responsibilities?
The application should demonstrate strong institutional support and, when applicable, a commitment to serve as the FDA regulatory sponsor, taking on sponsor responsibilities described in federal regulations (for example, 21 CFR 312 for drugs).
29. What additional requirements apply if the project meets the definition of a clinical trial?
Funded clinical trials 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 by federal human subjects regulations.
30. What type of award instrument is used (grant vs cooperative agreement)?
Awards are made as assistance agreements, which may be issued either as grants or cooperative agreements depending on the anticipated level of DoD involvement during performance.
31. What is the maximum funding amount per award?
The mechanism allows up to $1.5 million in total costs per award over the full period of performance.
32. How much total funding was expected for FY2020 and how many awards?
For FY2020, the program expected to allocate about $6 million total to fund roughly four awards, with funding dependent on federal availability and on scientific and programmatic review outcomes.
33. How selective has the CTRA been historically (based on the information provided)?
Since its first offering in FY2016, the program had received 57 applications with 12 recommended for funding, indicating a relatively selective portfolio focused on practical clinical relevance.
34. What is the Funding Opportunity Number and CFDA listing?
Funding Opportunity Number: W81XWH-20-PRORP-CTRA. CFDA: 12.420.
35. Who can apply?
The opportunity was open to unrestricted applicant types, subject to any eligibility clarifications in the full announcement.
36. What was the application closing date for this opportunity?
The original application closing date was September 10, 2020.
37. When were awards expected to be made?
Awards were expected to be made no later than September 30, 2021.
38. Through when were FY2020 funds expected to remain available for use?
Funds were anticipated to come from FY2020 appropriations and were expected to remain available for use through September 30, 2026, consistent with the fiscal lifecycle of those funds.
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