DoD Gulf War Illness, Clinical Evaluation Award | W81XWH 21 GWIRP CEA

Opportunity Information: Apply for W81XWH 21 GWIRP CEA

The FY21 DoD Gulf War Illness Research Program (GWIRP) Clinical Evaluation Award is designed to move the most credible Gulf War Illness (GWI) research findings into studies that directly involve Gulf War Veterans. The emphasis is on translation of validated results, meaning applicants are expected to build on research that has already shown strong, objective evidence in the GWI field, including preclinical findings that are qualified and replicated. This award sits in the program's "Verification" phase of the research pipeline, where the goal is to confirm that proposed biomarkers or interventions hold up in appropriately designed clinical evaluations and are ready to inform larger, later-stage clinical trials.

Projects supported under this mechanism are expected to be clinical in nature and statistically meaningful. The solicitation encourages two main types of studies: (1) statistically powered biomarker trials that can validate biomarkers for use as clinical endpoints, and (2) proof-of-concept intervention trials, such as pilot studies, first-in-human efforts, and early phase trials (phase 1 through phase 2a). Clinical trials can test a range of approaches, including pharmacologic agents (drugs or biologics), devices, clinical guidance, and other technologies, as long as there is strong objective evidence supporting the approach in the context of GWI. Repurposed treatments from other conditions that share symptom overlap with GWI can be proposed, but the program clearly signals a preference for studies that specifically translate qualified findings generated within the GWI research community rather than relying primarily on analogies to other disorders.

Biomarker-focused applications have additional expectations: they must expand preliminary findings in a sufficiently large Gulf War Illness cohort to produce statistically meaningful results, and the intended outcome should be biomarker validation that enables the biomarker to function as a clinical endpoint in later, larger-scale trials (phase 2b to phase 3). Across all applications, the research must be conducted in a Gulf War Veteran population, and applicants must provide proof that they have access to the necessary cohorts and/or any critical reagents. The application must also present a realistic clinical timeline, and budgets are expected to match the phase and scale of the proposed trial. Preclinical-only projects are explicitly steered to other GWIRP funding announcements rather than this award.

The opportunity includes two optional paths that can increase the maximum allowable direct costs, but they are mutually exclusive. First, the Biorepository Contribution Option supports applicants who will contribute Gulf War Veteran biospecimens and/or data to the established GWI biorepository network, the Boston Biorepository, Recruitment, and Integrative Network (BBRAIN) for GWI. To qualify for the higher funding level, applicants must submit a Biorepository Contribution Statement with detailed proposed costs and commit to BBRAIN protocols and standard operating procedures to ensure quality and consistency. Second, the Clinical Consortium Collaboration Option encourages applicants to leverage the existing infrastructure of the Gulf War Illness Clinical Trials and Interventions Consortium (GWICTIC), including recruitment networks, existing protocols, Common Data Elements, and data management practices. This option requires a letter of commitment or collaboration from the GWICTIC describing what services or infrastructure will be shared and how that collaboration adds value to the government, along with a Collaboration Statement detailing costs and commitments to GWICTIC procedures. Because GWICTIC has its own biospecimen and data policies, applications using this consortium option cannot also apply under the biorepository contribution option.

The solicitation also draws clear boundaries on what will not be supported. It does not fund studies that treat psychiatric disease or psychological stress as the primary cause of Gulf War Illness, nor projects that implement care guidelines placing major emphasis on psychiatric pathologies or psychiatric remedies. It also does not support applications focused on amyotrophic lateral sclerosis (ALS) research, although studies centered on GWI symptomatology may include Gulf War Veterans with ALS if ALS is included within the study's GWI case definition; separate ALS-focused funding is available through the DoD ALS Research Program.

Awards are issued as assistance agreements, meaning they will be made either as grants or cooperative agreements depending on how much involvement the Department of Defense anticipates having during the work. If no substantial involvement is expected, the award is typically a grant; if substantial involvement is expected (for example, active collaboration, participation, or intervention in aspects of the research), it is structured as a cooperative agreement, with the specific involvement spelled out during negotiation.

On funding levels, the anticipated maximum direct costs for the entire period of performance are capped at $1,500,000 for standard applications. The cap increases slightly to $1,520,000 for projects qualifying under the Biorepository Contribution Option, and to $1,700,000 for projects qualifying under the Clinical Consortium Collaboration Option. Program-wide, the DoD expected to allocate about $7.2 million total to fund roughly three awards under this mechanism, with final funding dependent on federal fund availability, application volume, and the results of scientific and programmatic review. The opportunity was posted in March 2021 with an original closing date of August 19, 2021, and anticipated awards were to be made no later than September 30, 2022, with FY21 funds expected to remain available for use through September 30, 2027. Eligible applicants are broadly unrestricted by entity type (subject to any additional requirements in the full announcement), and the sponsoring agency is the Department of Defense, Department of the Army, USAMRAA, under CFDA 12.420.

• 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 Gulf War Illness, Clinical Evaluation 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 11, 2021.
• Applicants must submit their applications by Aug 19, 2021. (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 3 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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