Peer Reviewed Orthopaedic Clinical Trial Award — Defense Health Agency Contracting Activity - DHACA funding opportunity
Defense Health Agency Contracting Activity - DHACA · Federal agency

Peer Reviewed Orthopaedic Clinical Trial Award

The PRORP Clinical Trial Award mechanism was first offered in FY09. Since then, 191 Clinical Trial Award applications have been received, and 18 have been recommended for funding. The PRORP Clinical Trial Award supports...

85
match
Award $0 Deadline 3482 days ago Location Alabama Type grant Level Federal Closed posted Aug 2, 2016
✦ AI Summary
  • Who can apply: Federal-level applicants (see eligibility for details).
  • Funding amount: total funding pool ~$9,000,000.
  • Next deadline: December 7, 2016.
  • Issued by: Defense Health Agency Contracting Activity - DHACA.
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The “key facts” mode pulls structured fields directly from the official source posting (amount, deadline, eligibility tags). The AI mode adds a short plain-English narrative on top, generated from the same source. Always verify with the agency before applying.

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Award amount
$0
Deadline
3482 days ago
Dec 7, 2016
Total pool
$9M

About this opportunity

The PRORP Clinical Trial Award mechanism was first offered in FY09. Since then, 191 Clinical Trial Award applications have been received, and 18 have been recommended for funding. The PRORP Clinical Trial Award supports the 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 from this award mechanism must support a clinical trial and may not be used for preclinical research studies. A clinical trial is defined as a prospective accrual of human subjects where an intervention ( procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. The term “human subjects” is used in this Program Announcement/Funding Opportunity to refer to individuals who will be recruited for or who will participate in the proposed clinical trial. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/ All applications are required to articulate the relevance of the proposed project to military and/or Veteran populations affected by orthopaedic injury. Collaboration with military and VA researchers and/or clinicians is encouraged. Studies that include active duty military or Veteran participants as all or a portion of the study population are encouraged. Proposed projects may range from small proof-of-concept trials to demonstrate feasibility or inform the design of more advanced trials ( pilot, first in human, or Phase 0), through large-scale trials to determine efficacy in relevant patient populations. All funding amounts requested should be well-justified and appropriate to the scope of work proposed. If the clinical trial involves the use of a drug that has not been approved by the Food and Drug Administration (FDA) for the proposed investigational use, then an Investigational New Drug (IND) application to the FDA that meets all requirements under the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312) may be required and must be submitted to the FDA within 6 months of the award date. If the investigational product is a device, evidence that an Investigational Device Exemption (IDE) application that meets all requirements under 21 CFR 812 has been submitted to the FDA within 6 months of the award date, or that the device is exempt from an IDE, is required. The Government reserves the right to withdraw funding if an IND or IDE is necessary but has not been submitted to the FDA within 6 months of the award date, or if documented status of the IND or IDE has not been obtained within 12 months of the award date. This award is intended to support clinical trial studies that have potential to develop novel interventions in either surgical care or rehabilitation. Animal research is not allowed under the FY16 PRORP Clinical Trial Award. The following are important aspects of submission for the Clinical Trial Award:  The proposed clinical trial is expected to begin no later than 12 months after the award date, or 18 months for FDA-regulated studies.  The proposed intervention to be tested should offer significant potential impact for military personnel and Veterans with combat-related orthopaedic injuries or non-battle orthopaedic injuries that impact unit readiness and return-to-duty/work.  Inclusion of preliminary data relevant to the proposed clinical trial is required.  The proposed clinical trial must be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature.  The application should describe the planned indication for the product label, if appropriate.

Funding agency

Defense Health Agency Contracting Activity - DHACA
Federal agency

Tags

Healthcare & Biotech Manufacturing Education & Research Veterans Transportation & Logistics Science, Tech & Engineering (STEM)
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Who can apply

Eligibility details aren't on file yet — check the agency source link in the Documents tab for the latest rules.

Geographic eligibility

  • Alabama
  • Alaska
  • Arizona
  • Arkansas
  • California
  • Colorado
  • Connecticut
  • Delaware
  • Florida
  • Georgia
  • Hawaii
  • Idaho
  • Illinois
  • Indiana
  • Iowa
  • Kansas
  • Kentucky
  • Louisiana
  • Maine
  • Maryland
  • Massachusetts
  • Michigan
  • Minnesota
  • Mississippi
  • Missouri
  • Montana
  • Nebraska
  • Nevada
  • New Hampshire
  • New Jersey
  • New Mexico
  • New York
  • North Carolina
  • North Dakota
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • Rhode Island
  • South Carolina
  • South Dakota
  • Tennessee
  • Texas
  • Utah
  • Vermont
  • Virginia
  • Washington
  • West Virginia
  • Wisconsin
  • Wyoming
  • District of Columbia

How to apply

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Source documents

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Canonical NOFO, application packet, and forms
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Citation details

Source systemgrants.gov
Source ID286857
PostedAug 2, 2016

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