DoD Gulf War Illness, Therapeutic/Biomarker Trial Award | W81XWH 20 GWIRP TBTA

Opportunity Information: Apply for W81XWH 20 GWIRP TBTA

The DoD Gulf War Illness Research Program (GWIRP) Therapeutic/Biomarker Trial Award (FY20) is designed to fund large, pivotal clinical trials for Gulf War Illness (GWI), generally in the Phase IIb to Phase III range. The intent is to push the field past early exploration and into the "confirmation" stage, meaning projects need to be ready to test whether an intervention truly works at a scale and rigor that could change real-world clinical practice for Gulf War Veterans. The program is not looking for incremental improvements or small pilot studies; it is aimed at trials that could meaningfully "revolutionize" clinical management of GWI and offer an approach that is clearly better than therapies already approved or currently in development.

A defining feature of this award is that the clinical trial must integrate objective biomarkers directly into the trial design. These biomarkers are expected to do one of two things: (1) objectively measure the biological effect of the investigational therapy (for example, demonstrating target engagement or a measurable physiological change tied to the treatment), or (2) serve as predictive or cohort-selective biomarkers that help identify which individual Veterans, or which GWI subgroups, are most likely to respond to a specific therapy. The program explicitly does not support biomarker work that is disconnected from therapeutic development, such as biomarker projects focused only on diagnosis, prognosis, or tracking disease progression without a clear link to evaluating or advancing a therapy.

The award requires that the funded work be a clinical trial; preclinical or non-trial research is directed to other GWIRP opportunities. Principal Investigators are expected to have proven experience leading large-scale projects and the practical capability to execute a complex clinical study, either through their own track record or by including an appropriately experienced clinical collaborator. Applications must include preliminary data relevant to Gulf War Illness and the proposed trial, reinforcing that the project should be built on a credible evidence base rather than speculative ideas.

Because many pivotal trials involve regulated drugs or devices, the announcement places heavy emphasis on regulatory readiness. If U.S. Food and Drug Administration involvement is required, the applicant must show, at the time of application, that key pieces are already in place: access to the therapeutic or device under regulatory-compliant conditions; access to the appropriate subject population; realistic and validated recruitment projections; and submission of an Investigational New Drug (IND) application or Investigational Device Exemption (IDE) application to the FDA that meets applicable federal requirements (including 21 CFR 312 for INDs). If an IND or IDE is not required, the applicant must provide evidence from the Institutional Review Board (IRB) of record or from the FDA supporting that determination. Importantly, if an IND or IDE is required, it must be submitted by the application deadline, and it must match the actual product/device and indication proposed for the trial. The government also reserves the right to withdraw funding if a required IND/IDE (or relevant international regulatory submission) was not filed by the deadline.

The program also encourages applicants to plug into existing Gulf War Illness research infrastructure through two optional collaboration paths that can come with higher funding levels if the application qualifies. The first is the Biorepository Contribution Option, tied to the Boston Biorepository, Recruitment, and Integrative Network (BBRAIN) for GWI. Applicants are encouraged to contribute Gulf War Veteran biospecimens and associated data to support broader GWI research efforts. The second is the Clinical Consortium Collaboration Option, which encourages applicants to use the established infrastructure of the Gulf War Illness Clinical Trials and Interventions Consortium (GWICTIC), including recruitment networks, existing protocols, Common Data Elements, and data management procedures. If an applicant chooses the Clinical Consortium Collaboration Option, they must provide a formal letter of collaboration from GWICTIC describing what will be shared and how it benefits the government, and they cannot also apply under the Biorepository Contribution Option because consortium policies govern biospecimen and data handling.

Operational expectations for applicants are extensive and reflect the complexity of late-stage clinical trials. The trial is expected to begin within 12 months of the award date (or within 18 months for FDA-regulated studies). The application must present a strong recruitment and retention plan and demonstrate access to a sufficient Gulf War Veteran population to achieve statistically meaningful results. The awardee will work with the U.S. Army Medical Research Acquisition Activity (USAMRAA) to set recruitment milestones, and continued funding is tied to satisfactory progress against those milestones. Applicants must also document therapeutic access for the full study duration and address product quality and stability consistent with applicable FDA manufacturing standards (such as GMP expectations, depending on the product and development stage).

From a trial quality and compliance standpoint, the application is expected to include a clear statistical analysis plan, appropriate statistical expertise, and a power analysis supporting sample size and feasibility. It must also include a safety management plan for pharmacovigilance (as applicable), a clinical monitoring plan to ensure Good Clinical Practice compliance, and a data management plan with an appropriate database to protect data integrity. If the study is FDA-regulated, the data system must be 21 CFR Part 11 compliant and follow appropriate electronic data standards. The program also expects a dedicated study coordinator or coordinators to manage IRB and other regulatory processes, coordinate multi-site activities, and support participant accrual.

A key forward-looking requirement is a Transition Plan explaining how, if the trial is successful, the product will move to the next phase of clinical testing and/or toward real delivery to Veterans with GWI. Applicants must also demonstrate strong institutional support, and where relevant, a commitment to serve as the FDA regulatory sponsor and fulfill sponsor responsibilities under federal regulations. Funded trials must be registered on ClinicalTrials.gov prior to initiation.

The announcement also draws clear boundaries around what it will not fund. It will not support studies that treat psychiatric disease or psychological stress as the primary cause of Gulf War Illness, nor projects that implement care guidelines heavily centered on psychiatric pathologies or psychiatric remedies. It also does not support applications focused on amyotrophic lateral sclerosis (ALS) research, although Gulf War Veterans with ALS can be included if ALS is part of the study's GWI case definition and the focus remains on GWI symptomatology.

In terms of funding mechanics, awards are made as assistance agreements, meaning either grants or cooperative agreements depending on how much involvement the DoD anticipates during performance. Direct costs for the full period of performance are capped at $5,000,000 for a Therapeutic/Biomarker Trial Award, with the overall program expecting to allocate roughly $8,000,000 to fund about one award in this cycle. Awards were expected to be made by September 30, 2021, and the FY20 funds anticipated for these awards were expected to remain available for use until September 30, 2026. Eligibility is broadly unrestricted (open to many entity types), with final funding decisions dependent on federal fund availability and on scientific and programmatic review outcomes.

• 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, Therapeutic/Biomarker Trial 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 24, 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 1 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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