DoD Gulf War Illness, Therapeutic/Biomarker Trial Award — Defense Health Agency Contracting Activity - DHACA funding opportunity
Defense Health Agency Contracting Activity - DHACA · Federal agency

DoD Gulf War Illness, Therapeutic/Biomarker Trial Award

The FY21 GWIRP Therapeutic/Biomarker Trial Award supports large-scale, pivotal ( phase 2b-3) clinical trials that will revolutionize the clinical management of GWI. The Therapeutic/ Biomarker Trial Award targets the Conf...

75
match
Deadline 1766 days ago Location Alabama Type grant Level Federal Closed posted Mar 11, 2021
✦ AI Summary
  • Who can apply: Federal-level applicants (see eligibility for details).
  • Funding amount: total funding pool ~$8,000,000.
  • Next deadline: August 19, 2021.
  • 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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Deadline
1766 days ago
Aug 19, 2021
Total pool
$8M

About this opportunity

The FY21 GWIRP Therapeutic/Biomarker Trial Award supports large-scale, pivotal ( phase 2b-3) clinical trials that will revolutionize the clinical management of GWI. The Therapeutic/ Biomarker Trial Award targets the Confirmation phase of the research pipeline as outlined in Section II.A.2. The proposed research should lead to an approach that is fundamentally better than interventions already approved or in clinical development. Objective biomarkers to measure the biological effect of an investigational therapeutic or predictive/cohort-selective biomarkers that indicate whether a specific therapy will be effective in an individual Gulf War Veteran or Gulf War Veteran subgroup must be included in the trial design.Development of markers for the purposes of measurement of disease progression without consideration of the therapeutic development process will not be supported.The FY21 GWIRP Therapeutic/Biomarker Trial Award supports clinical trials; therefore, all applications must address the FY21 GWIRP Overarching Challenge of “Treatments.” In addition, applicants may consider The Gulf War Illness Landscape and the GWIRP’s mission and address any of the other FY21 GWIRP Overarching Challenges or a different challenge identified and justified in the application.Principal Investigators (PIs) are expected to have experience in successfully leading large-scale projects and demonstrated ability (through personal experience or via a commitment from a collaborating clinical investigator) to implement a clinical project successfully.Funding from this award mechanism must support a clinical trial.A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. Funded clinical trials are required to post a copy of the Institutional Review Board (IRB)-approved informed consent form used to enroll subjects on a publicly available federal website in accordance with federal requirements described in the Code of Federal Regulations, Title 32, Part 219 (2 CFR 219).Clinical research is defined as: (1) Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies; (2) epidemiologic and behavioral studies; and (3) outcomes research and health services research. Note: Studies that meet the requirements for IRB review Exemption 4 are not considered CDMRP-defined clinical research. IRB Exemption 4 refers to research involving the collection or study of existing de-identified specimens or data, if these sources are publicly available.Investigators seeking funding for a preclinical research project should consider one of the other FY21 GWIRP program announcements being offered.For proposed research that will require Food and Drug Administration (FDA) involvement, project readiness requirements at the time of application submission include: proof of availability of and access to clinical reagents ( therapeutics) that meet regulatory compliance guidelines, proof of availability of and access to appropriate subject population(s), validated projections for patient recruitment, and submission of an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application to the FDA that meets all requirements under 21 CFR 312.

Funding agency

Defense Health Agency Contracting Activity - DHACA
Federal agency

Tags

Healthcare & Biotech Manufacturing Arts & Culture Education & Research Construction & Housing 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 ID332039
PostedMar 11, 2021

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