Tag Archives: Defense Health

Department of Defense Peer Reviewed Orthopaedic Research Program

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The FY20 Defense Appropriations Act provides funding to the Department of Defense Peer Reviewed Orthopaedic Research Program (PRORP) to support innovative, high-impact, clinically-relevant research to advance optimal treatment and rehabilitation from musculoskeletal injuries. As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency J9, Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC).

The FY20 PRORP Program Announcements and General Application Instructions for the following award mechanisms are posted on the Grants.gov website. 

Applications submitted to the FY20 PRORP must address one or more of the following FY20 Focus Areas:

  • Compartment Syndrome: Novel treatment strategies to improve current diagnoses for compartment syndrome. Alternatives to intracompartmental pressure measurements are encouraged.
  • Limb Stabilization and Protection: Development and/or clinical assessment of rapid limb stabilization and novel wound protectants for severely wounded limbs to enable transport at the point of need.
  • Orthotic Devices: Refinement of high-performance novel orthotic devices designed to enhance whole person performance and decrease pain in patients with limb salvage and impairment.
  • Osseointegration: Identification of best practices to address infection, rejection, and/or failure of percutaneous osseointegrated prosthetic limbs. 
  • Retention Strategies: Development, optimization, and/or validation of battlefield-feasible diagnostic capabilities, decision support tools, interventions, and/or rehabilitation strategies that can facilitate retention on duty for common combat-related musculoskeletal injuries.  Biomarker studies are excluded.  The current standard of care must be noted.  The rehabilitation strategy and the standard of care must be specified, as applicable.
    • Point of Injury: Battlefield-feasible strategies that can be utilized at or near the point of injury to allow an injured Service member to remain on duty and stay on mission without the need for immediate evacuation
    • Point of Duty: Strategies that can be utilized along the continuum of care to allow an injured Service member to return to duty without separation from Service.
  • Tissue Regeneration Therapeutics: Development of advanced tissue regeneration therapeutics in nerve, muscle (to include volumetric muscle loss), and/or composite tissue for the restoration of traumatically injured extremities.  Isolated bone or cartilage tissue engineering studies are excluded.
  • Translation of Early Findings: Translation of early research findings in the orthopaedic surgical care topic areas listed below to move the research toward clinical trials and clinical practice.
    • Soft Tissue Trauma: Strategies to develop and/or identify musculoskeletal extremity soft tissue trauma treatments for anterior cruciate ligament (ACL) or shoulder instability only, to optimize return to duty, work, or reintegration
    • Fracture-Related Infection: Strategies to decrease the burden of fracture-related infections (may include prevention, early detection, or improved eradication).  Alternatives to systemic and/or local antibiotic delivery are encouraged. 

https://cdmrp.army.mil/funding/prorp

Applied Research Award – Preproposal due May 27, 2020. Independent investigators at all academic levels (or equivalent):

  • Pre-application is required; full application submission is by invitation only.
  • Supports applied research applications focused on advancing optimal treatment and restoration of function for individuals with musculo-skeletal injuries sustained during combat or combat-related activities, and non-battle injuries that impact unit readiness and the ability to return to duty/work.
  • Proposed research should be supported by preliminary data and have the potential to make significant advancements toward clinical translation.
  • Clinical research and clinical trials are not allowed under this award mechanism.
  • Applications must address one of the following FY20 PRORP Focus Areas:
    • Limb Stabilization and Protection
    • Retention Strategies
      • Point of Injury
      • Return to Duty
  • Osseointegration

Maximum funding of $725,000 for total costs (includes direct and indirect costs). Maximum period of performance is 3 years.

Clinical Trial Award – Preproposal due May 27, 2020.Independent investigators at all academic levels (or equivalent):

  • Pre-application is required; full application submission is by invitation only.
  • Supports rapid implementation of clinical trials with the potential to have a major impact on military combat-related orthopaedic injuries or non-battle injuries that significantly impact unit readiness and return-to-duty/work rates.
  • Funding must support a clinical trial and may not be used for preclinical research studies.
  • Investigational New Drug or Investigational Device Exemption applications, if needed, should be submitted to the Food and Drug Administration within 6 months of the award date.
  • Applications must address one the following FY20 PRORP Focus Areas:
    • Limb Stabilization and Protection
    • Retention Strategies
      • Point of Injury
      • Return to Duty
    • Translation of Early Findings
      • Soft Tissue Trauma
      • Fracture-Related Infection

Funding Level 1:Maximum funding of $2.25M for total costs. (includes direct and indirect costs). Maximum period of performance is 4 years.

Funding Level 2 (Translation of Early Findings – Soft Tissue Trauma Focus Area with Rehabilitation Option): Maximum funding of $2.75M for total costs (includes direct and indirect costs). Maximum period of performance is 4 years.

Clinical Translational Research Award – Preproposal is due May 27, 2020. Independent investigators at all academic levels (or equivalent):

  • Pre-application is required; full application submission is by invitation only.
  • Supports high-impact and/or new/emerging clinical research that may or may not be ready for a full-scale, randomized, controlled clinical trial.
  • Funding must support clinical research studies involving humans.
  • Preliminary or published data relevant to the proposed research project are required.
  • Investigational New Drug or Investigational Device Exemption applications, if needed, should be submitted to the Food and Drug Administration within 12 months of the award date.
  • Applications must address one of the following FY19 PRORP CTRA Focus Areas:
    • Retention Strategies
      • Point of Injury
      • Return to Duty
    • Tissue Regeneration Therapeutics
    • Compartment Syndrome
    • Osseointegration
    • Orthotic Devices

Maximum funding of $1.5M for total costs (including direct and indirect costs). Maximum period of performance is 4 years.

A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) prior to the pre-application deadline. All applications must conform to the final Program Announcements and General Application Instructions available for electronic downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov by performing a basic search using CFDA Number 12.420. 

For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage. For more information about the PRORP or other CDMRP-administered programs, please visit the CDMRP website.

Department of Defense Orthotics and Prosthetics Outcomes Research Program – Funding Opportunities for Fiscal Year 2018 (FY18)

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The FY18 Defense Appropriation provides $10 million (M) to the Department of Defense Orthotics and Prosthetics Outcomes Research Program (OPORP) to support research that evaluates the comparative effectiveness of orthotic and prosthetic clinical interventions using patient-centric outcomes for Service members and Veterans who have undergone limb amputation.  As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency J9, Research and Development Directorate, manages the Defense Health Program Research, Development, Test, and Evaluation appropriation.  The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Materiel Command (USAMRMC).

The OPORP is providing the information in this pre-announcement to allow investigators time to plan and develop applications.  FY18 OPORP Program Announcements and General Application Instructions for the following award mechanisms are anticipated to be posted on the Grants.gov website in June 2018.  Pre-application and application deadlines will be available when the Program Announcements are released.  This pre-announcement should not be construed as an obligation by the government.

OPORP awards are focused on outcomes-based best practices through analysis of the merits of prosthetic and orthotic device options currently available, not on the development of new or the improvement of existing technology.  The intent of the awards is to generate clinically useful evidence that will enhance and optimize patient outcomes.

Focus Areas:  The OPORP will only consider applications that specifically address the critical needs of the Orthotics and Prosthetics Outcomes research community in one or more of the FY18 Focus Areas.  The OPORP will solicit research applications that address at least one of the following FY18 Focus Areas:

  • Orthotic or Prosthetic Device Form:  Understand patient outcomes through the analysis and characterization of variables related to the form of currently available clinical options such as device size, shape, material, and/or configurations.
  • Orthotic or Prosthetic Device Fit:  Understand patient outcomes related to human-device interface and component connection through the analysis of variables in currently available clinical options that facilitate fit-related metrics such as comfort and/or usability.
  • Orthotic or Prosthetic Device Function:  Understand patient outcomes through the analysis of variables related to currently available device function such as device control, sensors, and passive or active response with respect to activities of daily living and other real-world activities.

http://cdmrp.army.mil/pubs/press/2018/18oporppreann

Clinical Research Award

  • Independent investigators at all academic levels (or equivalent)
  • Funding Level 1 may support pilot research that has the potential to make significant advancement towards clinical translation. Preliminary data are allowed but not required.
  • Funding Level 2 is supported by preliminary data and has the potential to make significant impact towards clinical translation.
  • Animal studies are not allowed.
  • Clinical trials are not allowed.
  • Funding Level 1:
    • Maximum funding of $350,000 for total costs.
    • Maximum Period of performance is 2 years.
  • Funding Level 2:
    • Maximum funding of $1.5M for total costs.
    • Maximum period of performance is 4 years.

Clinical Trial Award

Independent investigators at all academic levels (or equivalent

  • Funding Level 1 may support pilot clinical trials for exploratory studies involving limited human exposure with the potential to make significant advancement towards clinical translation. Preliminary data are allowed but not required.
  • Funding Level 2 supports rapid implementation of clinical trials with the potential to make significant impacts on improving the health and well-being of Service members, Veterans, and other individuals with limb deficit.
  • Preclinical research is not allowed.
  • Funding Level 1:
    • Maximum funding of $350,000 for total costs.
    • Maximum Period of performance is 2 years.
  • Funding Level 2:
    • Maximum funding of $2.5M for total costs.
    • Maximum period of performance is 4 years.

A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline.  All applications must conform to the final Program Announcements and General Application Instructions that will be available for electronic downloading from the Grants.gov website.  The application package containing the required forms for each award mechanism will also be found on Grants.gov.  A listing of all CDMRP and other USAMRMC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

Submission deadlines are not available until the Program Announcements are released.  For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org.  For more information about the OPORP or other CDMRP-administered programs, please visit the CDMRP website (http://cdmrp.army.mil).

Point of Contact:

CDMRP Public Affairs
301-619-9783
usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@mail.mil

 

Department of Defense Spinal Cord Injury Research Program – Funding Opportunities for Fiscal Year 2018 (FY18)

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The FY18 Defense Appropriation provides $30 million (M) to the Department of Defense Spinal Cord Injury Research Program (SCIRP) to support innovative, high-impact spinal cord injury research. As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency, J9 Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Materiel Command (USAMRMC).

FY18 SCIRP Program Announcements and General Application Instructions for the following award mechanisms are posted on the Grants.gov website.

For FY18, SCIRP encourages applications that address the critical needs of SCI research and patient care in one or more of the following FY18 Focus Areas:

  • Neuroprotection
  • Biomarkers
  • Bladder and bowel dysfunction and neuropathic pain
  • Psychological issues relevant to Spinal Cord Injuries (SCI) in individuals with SCI and their caregivers
  • Rehabilitation and regeneration

http://cdmrp.army.mil/funding/scirp

Clinical Trial Award – Preproposal due July 9, 2018

  • Independent investigators at all academic levels (or equivalent)
  • Preproposal is required; application submission is by invitation only.
  • Fund Phase 0, I, or II clinical trials with the potential to have a major impact on treatment or management of spinal cord injury (SCI) and its consequences.
  • Preclinical data required for all clinical trial applications.
  • Maximum funding of $3M for direct costs (plus indirect costs)
  • Maximum period of performance is 4 years

Investigator-Initiated Research Award – Preproposal due July 9, 2018

  • Independent investigators at all academic levels (or equivalent)
  • Preproposal is required; application submission is by invitation only.
  • Fund SCI-related research that has the potential to make an important contribution to SCI research and/or patient care.
  • Preliminary data required.
  • Clinical trials not allowed.
  • Maximum funding of $500,000 for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years.

Qualitative Research Award – Preproposal due July 9, 2018

  • Independent investigators at all academic levels (or equivalent)
  • Preproposal is required; application submission is by invitation only.
  • Fund qualitative research on military Service members and Veterans in the years following SCI.
  • Qualitative research is defined as a form of social inquiry that focuses on understanding the way that people interpret and make sense of their experiences and the world in which they live (i.e., seek to understand the human experience).
  • Preliminary data encouraged, but not required.
  • Clinical trials not allowed.
  • Maximum funding of $500,000 for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years

Translational Research Award – Preproposal due July 9, 2018

  • Independent investigators at all academic levels (or equivalent)
  • Preproposal is required; application submission is by invitation only.
  • Fund studies that accelerate the movement of promising ideas in SCI research into clinical applications.
  • Preliminary data required
  • The SCIRP TRA may include a pilot clinical trial as part of the proposed research where limited clinical testing of a novel intervention or device is necessary to inform the next step in the continuum of translational research.
  • Maximum funding of $1.25M for direct costs (plus indirect costs)
  • Maximum period of performance is 3 years

A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Program Announcements and General Application Instructions available for electronic downloading from the Grants.gov website.  The application package containing the required forms for each award mechanism will also be found on Grants.gov.  A listing of all CDMRP and other USAMRMC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420. 

For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org.  For more information about the SCIRP or other CDMRP-administered programs, please visit the CDMRP website   (http://cdmrp.army.mil <http://cdmrp.army.mil).

Point of Contact:

CDMRP Help Desk

301-682-5507

help@eBrap.org