DoD Gulf War Illness Clinical Trial Development Award | Apply Online

Opportunity Summary:

The DoD Gulf War Illness Clinical Trial Development Award (CTDA) is a one-year funding opportunity under the Department of the Army (USAMRAA) Gulf War Illness Research Program (GWIRP) designed to pay for the upfront planning work needed to launch a future Phase II or Phase III clinical trial, including trials of medical devices that fall within FDA device Classes I through III. The program was created because the pre-trial development stage often requires substantial time, coordination, and specialized planning resources, even when the underlying scientific rationale for the trial is already strong. In practical terms, the CTDA is meant to help a team move from a well-supported treatment idea to a fully prepared, review-ready clinical trial package.

A central feature of the CTDA is what it will not fund. It is not a mechanism for collecting new preliminary data, and it is not meant to support pilot studies that generate early signals of efficacy or feasibility. Instead, applicants are expected to come in with the trial rationale already clearly established and backed by appropriate supportive preliminary data. The award is essentially for converting an already-justified intervention concept into an operationally sound clinical trial plan that can withstand scientific review and be positioned for follow-on funding and execution.

The types of activities supported are the nuts-and-bolts components required to stand up a credible Phase II or Phase III effort. This includes developing the clinical protocol and experimental design in detail, building and organizing the research team, setting up collaborations across sites or institutions, and creating training procedures where needed to ensure consistent implementation. It can also cover work related to intellectual property or material property questions, which can become critical when an intervention involves proprietary compounds, devices, or specialized formulations. Because recruitment is often one of the biggest barriers in Gulf War Illness research, the CTDA explicitly supports establishing access to an ill Gulf War veteran population and developing a recruitment strategy that is realistic and compliant with clinical research requirements.

The award also emphasizes operational rigor and readiness for later-stage trials. Supported planning activities include quality control and quality assurance procedures, data collection and data management workflows, and a full data analysis and statistical plan. Applicants can use funds to address practical test article concerns such as purity, formulation, and related readiness issues that could affect dosing, stability, or reproducibility. Safety infrastructure is another key area: the CTDA supports developing a safety monitoring plan and, when applicable, planning the path to FDA regulatory submissions such as an Investigational New Drug (IND) application for drugs/biologics or an Investigational Device Exemption (IDE) for devices. Finally, the award allows for building a transition plan that spells out how the project will move into the next stage, including the resources, partnerships, and steps required to proceed to a full trial or, where relevant, commercialization.

Administratively, this opportunity (Funding Opportunity Number W81XWH-13-GWIRP-CTDA) was offered as a discretionary program using a grant/cooperative agreement instrument type within the Science and Technology / Research and Development category. It listed an expected two awards and an estimated total funding amount of $320,000, with no cost sharing or matching requirement. Eligibility was described as unrestricted, meaning any entity type could apply unless further limited by additional eligibility language in the full announcement. The opportunity was posted May 14, 2013, with a closing date of September 18, 2013 (archived October 18, 2013), and it carried the CFDA number 12.420 (Military Medical Research and Development).

For investigators who are not yet at the point of having a well-supported clinical trial rationale, the announcement points them toward other GWIRP mechanisms instead of the CTDA. Specifically, those needing proof-of-principle or foundational data are directed to the Investigator-Initiated Research Award for basic research on Gulf War Illness, or the Innovative Treatment Evaluation Award for small, early-phase or pilot clinical trials (Phase II or Phase I/II) that evaluate an intervention at an earlier stage than a definitive Phase II/III effort. Contact support for announcement access was provided through the CDMRP Help Desk (301-682-5507).

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