Opportunity Information: Apply for W81XWH 19 GWIRP TBTA
The DoD Gulf War Illness, Therapeutic/Biomarker Trial Award (FY19 GWIRP TBTA; Funding Opportunity Number W81XWH 19 GWIRP TBTA) is a Department of Defense research funding opportunity focused specifically on running large, pivotal clinical trials for Gulf War Illness (GWI). The intent is not early discovery work or small pilot testing, but confirmatory, later-stage human studies on the scale of Phase IIb through Phase III that are capable of changing clinical practice. In other words, the program is looking for trials designed to produce strong, practice-shaping evidence that could meaningfully improve how GWI is treated and managed in real clinical settings.
A central requirement of this award is that the proposed clinical trial must integrate objective biomarkers into the study design. These biomarkers have to be tied directly to therapeutic development and decision-making. The announcement emphasizes two acceptable biomarker roles: (1) biomarkers that objectively measure the biological effect of the investigational therapy (for example, measurable changes in inflammation, neuroimmune signaling, metabolism, or other relevant biological pathways that indicate whether the drug or intervention is doing what it is supposed to do), and/or (2) predictive or cohort-selective biomarkers that help determine whether a therapy is likely to work for a particular Gulf War Veteran or a defined subgroup of Veterans. The purpose here is to move beyond one-size-fits-all treatment and toward evidence-based approaches that can identify who benefits, how they benefit, and how that benefit can be verified biologically during the trial.
The opportunity is also explicit about what it will not support. Biomarker development aimed only at diagnosis, prognosis, or tracking disease progression, without being integrated into the therapeutic development process, is not responsive to the goals of this award. Similarly, preclinical projects are not a fit; funding under this mechanism must support an actual clinical trial in humans. Applicants who want to do laboratory, animal, or other non-clinical preparatory research are directed to consider other Gulf War Illness Research Program announcements instead of this one.
From a competitiveness standpoint, the program expects the Principal Investigator to have the background and leadership capacity to run a major, multi-faceted clinical effort. That generally means demonstrated experience leading large-scale projects and clear capability to implement a clinical trial successfully, either through the PI's own track record or through a firm commitment from a collaborating clinical investigator who has that operational expertise. This requirement reflects the reality that pivotal trials involve complex elements like participant recruitment (in this case, Gulf War Veterans), compliance and retention, clinical site management, regulatory and human subjects protections, data coordination, and rigorous statistical planning.
Administratively, the sponsor is the Department of Defense, Department of the Army, through USAMRAA, and the award can be made as either a cooperative agreement or a grant under the Science and Technology / Research and Development category (CFDA 12.420). Eligibility is listed as unrestricted, meaning any type of entity may apply as long as it meets any conditions spelled out in the full announcement. The funding opportunity was created on May 16, 2019, with an original closing date of October 3, 2019. The listing indicates an expected number of awards of 1, underscoring that this mechanism is aimed at a single, high-impact, resource-intensive trial rather than distributing many smaller projects. The award ceiling is listed as 0 in the summary data, which typically signals that applicants need to refer to the full program announcement for budget guidance or that the ceiling is not specified in the extracted record.
Overall, this award is designed for teams that are ready to run a decisive, clinically meaningful GWI therapeutic trial and that can pair that trial with biomarkers that objectively show biological response and/or guide patient selection. The end goal is a treatment approach that is fundamentally better than what is already approved or currently in clinical development, with evidence strong enough to shift the clinical management of Gulf War Illness.Apply for W81XWH 19 GWIRP TBTA
- 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 May 16, 2019.
- Applicants must submit their applications by Oct 03, 2019. (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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Frequently Asked Questions (FAQs)
What is the DoD Gulf War Illness, Therapeutic/Biomarker Trial Award (FY19 GWIRP TBTA)?
It is a Department of Defense research funding opportunity intended to support large, pivotal clinical trials for Gulf War Illness (GWI). The focus is on later-stage, confirmatory human studies (on the scale of Phase IIb through Phase III) designed to produce strong evidence that could change clinical practice and improve real-world treatment and management of GWI.
What is the main purpose of this award?
The award is meant to fund a decisive, clinically meaningful therapeutic trial in humans for Gulf War Illness, paired with objective biomarkers that help demonstrate biological response to the therapy and/or help determine which Gulf War Veterans are most likely to benefit.
What kind of studies is this program looking to fund?
The program is looking for large, practice-shaping clinical trials in humans, designed as pivotal and confirmatory studies (Phase IIb to Phase III scale). The expectation is that the results could meaningfully influence clinical care for Gulf War Illness rather than serving as early exploratory signals.
Is early discovery research or pilot testing a good fit for this award?
No. The intent is not early discovery work or small pilot studies. The mechanism is designed for later-stage clinical testing that can deliver strong, confirmatory evidence.
Does the clinical trial have to be conducted in humans?
Yes. Funding under this mechanism must support an actual clinical trial in humans. Preclinical work (laboratory studies, animal studies, or other non-clinical preparatory research) is not responsive to this award.
Are biomarkers required in the trial design?
Yes. A central requirement is that the proposed clinical trial must integrate objective biomarkers into the study design, and those biomarkers must be tied directly to therapeutic development and decision-making.
What biomarker roles are considered responsive to this opportunity?
The opportunity highlights two acceptable biomarker roles:
- Biomarkers that objectively measure the biological effect of the investigational therapy (for example, measurable changes in inflammation, neuroimmune signaling, metabolism, or other relevant biological pathways showing whether the intervention is producing the intended biological impact).
- Predictive or cohort-selective biomarkers that help determine whether a therapy is likely to work for a particular Gulf War Veteran or a defined subgroup of Veterans (supporting more targeted, evidence-based treatment approaches rather than one-size-fits-all care).
Can biomarkers be used to verify therapeutic benefit biologically during the trial?
Yes. The intent is to understand who benefits, how they benefit, and to verify that benefit biologically during the trial using objective biomarkers that are integrated into therapeutic development and decision-making.
Are diagnostic, prognostic, or disease-progression biomarkers supported?
Not if they are only aimed at diagnosis, prognosis, or tracking disease progression and are not integrated into the therapeutic development process. Biomarker work must be directly tied to the investigational therapy and how it is developed, evaluated, or applied in the trial.
Is biomarker development by itself an allowable project under this mechanism?
No. The award is built around running a pivotal therapeutic clinical trial, with biomarkers integrated into that trial. Biomarker development that is not tied to a therapeutic trial and therapeutic decision-making is not responsive.
What level of experience is expected from the Principal Investigator (PI)?
The program expects the PI to have the background and leadership capacity to run a major, multi-faceted clinical effort. This generally means demonstrated experience leading large-scale projects and clear capability to implement a clinical trial successfully.
Can a collaborating clinical investigator provide the needed clinical trial leadership experience?
Yes. The expectation can be met through the PI's own track record or through a firm commitment from a collaborating clinical investigator who has the operational expertise to implement a large clinical trial.
What operational challenges does the program anticipate for applicants?
The announcement reflects that pivotal trials involve complex elements such as participant recruitment (including Gulf War Veterans), compliance and retention, clinical site management, regulatory and human subjects protections, data coordination, and rigorous statistical planning.
Who is the sponsoring agency for this opportunity?
The sponsor is the Department of Defense, Department of the Army, through USAMRAA.
What is the Funding Opportunity Number (FON) for this program?
W81XWH 19 GWIRP TBTA.
What type of award instrument is used?
The award may be made as either a cooperative agreement or a grant under the Science and Technology / Research and Development category.
What is the CFDA number associated with this opportunity?
CFDA 12.420.
Who is eligible to apply?
Eligibility is listed as unrestricted, meaning any type of entity may apply, as long as it meets any conditions specified in the full announcement.
How many awards does the program expect to make?
The listing indicates an expected number of awards of 1, suggesting the program is aimed at supporting a single, high-impact, resource-intensive trial rather than multiple smaller projects.
Is there a stated maximum award amount?
The summary data lists the award ceiling as 0. This typically means applicants need to consult the full program announcement for budget guidance, or that a specific ceiling is not provided in the extracted listing.
When was this funding opportunity created and when did it close?
The opportunity was created on May 16, 2019, with an original closing date of October 3, 2019.
What is the overall end goal of the award?
The end goal is a treatment approach for Gulf War Illness that is meaningfully better than what is already approved or currently in clinical development, supported by evidence strong enough to shift clinical management, and validated through integrated objective biomarkers.
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