DoD Gulf War Illness Clinical Trial Development Award | Apply Online

Frequently Asked Questions (FAQs)

What is the DoD Gulf War Illness Clinical Trial Development Award (CTDA)?

The CTDA is a one-year funding mechanism under the Gulf War Illness Research Program (GWIRP) designed to support the up-front planning work needed to launch a well-designed Phase II or Phase III clinical trial, including clinical trials of medical devices in FDA Classes I through III.

What is the main purpose of the CTDA?

The purpose is to fund "trial-readiness" activities so a future clinical trial is truly ready to execute. The award supports the time, effort, and infrastructure planning required before enrolling any participants, with the goal of producing a scientifically reviewed, trial-ready package.

How long is the CTDA performance period?

The CTDA is a one-year award.

What trial phases is the CTDA intended to support?

The CTDA supports planning for a future Phase II or Phase III clinical trial (including relevant medical device trials for FDA Classes I through III). It is not intended to support early phase testing activities.

Does the CTDA fund pilot studies or preliminary data collection?

No. The CTDA is not meant for collecting preliminary data, generating proof-of-concept results, or running pilot studies. It is not an "early results" award and is not a substitute for traditional investigator-initiated research or early phase treatment testing.

If I need preliminary data to justify a trial, what should I apply for instead?

Applicants who need to collect data to justify a trial are directed to other GWIRP mechanisms mentioned in the opportunity description, such as the Investigator Initiated Research Award (for basic research) or the Innovative Treatment Evaluation Award (for small, early phase or pilot clinical trials such as Phase I/II or Phase II).

What types of activities are allowable under the CTDA?

Allowable preparatory activities include planning and readiness tasks such as building the clinical protocol and experimental design; assembling the research team and collaborations (including training procedures when needed); addressing intellectual property or material transfer considerations; establishing access to an appropriately defined population of ill Gulf War veterans and creating a recruitment strategy; setting up quality assurance/quality control processes; building data collection and data management systems; and developing a detailed statistical analysis plan.

Can the CTDA support regulatory preparation like IND or IDE planning?

Yes. The CTDA can cover planning steps needed to finalize an FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) submission when applicable, and recipients are expected to begin and advance the IND/IDE process during the planning year.

Does the CTDA allow planning for medical device trials?

Yes. The CTDA explicitly includes planning for trials of medical devices in FDA Classes I through III.

Can the CTDA support work related to test article readiness (purity/formulation)?

Yes. The opportunity notes that practical trial-enabling tasks may include evaluating issues related to test article purity and formulation, as well as developing a safety monitoring plan.

What is meant by an "appropriately defined" cohort of ill Gulf War veterans?

GWIRP-supported clinical trials must recruit an appropriately defined cohort of ill Gulf War veterans, and applicants must specify a published case definition they will use to define Gulf War Illness (GWI). The case definition must reflect the multisymptom nature of GWI rather than treating it as a single-symptom condition.

Do applicants have to use a specific Gulf War Illness case definition?

Applicants must specify a published case definition for GWI. The announcement emphasizes that the definition must reflect GWI as a multisymptom illness.

Why does the opportunity emphasize the case definition and eligibility criteria?

The program signals that cohort definition and eligibility criteria are central to whether a future trial will be considered credible and relevant, not minor administrative details.

Does the opportunity reference any background resources on case definitions and prior research?

Yes. The opportunity points applicants to the 2008 Research Advisory Committee report, which discusses case definitions and summarizes prior treatment research in Gulf War veterans and related multisymptom conditions.

Is the CTDA intended to lead to another GWIRP funding mechanism?

Yes. The CTDA is structured as a bridge to a later, full clinical trial application, with the expectation that recipients will use the planning year to produce outputs that can be incorporated into a later GWIRP Clinical Trial Award (CTA) application.

Are CTDA awardees expected to apply for the GWIRP Clinical Trial Award (CTA)?

Yes. Awardees are expected to apply for the CTA in the program year following completion of the CTDA, using the planning outputs developed during the CTDA period.

Does receiving a CTDA guarantee future funding for the full clinical trial?

No. The CTDA does not guarantee future trial funding. A later CTA depends on the competitiveness of the application and the availability of federal funds.

Is eligibility for the later CTA restricted based on prior CTDA receipt?

Yes, as described in the opportunity: if the CTA is offered in later years referenced (FY13 or FY14), only investigators who previously received the FY11 CTDA would be eligible to submit a CTA application.

What human subjects approvals are required for DoD-funded work under this program?

Any DoD-funded work involving human subjects or human anatomical substances must receive approval from the local Institutional Review Board (IRB) and also from the U.S. Army Medical Research and Materiel Command Office of Research Protections, Human Research Protections Office (HRPO).

What is HRPO and why is it important here?

HRPO refers to the Human Research Protections Office within the U.S. Army Medical Research and Materiel Command Office of Research Protections. The opportunity emphasizes HRPO review/approval as a required layer of oversight in addition to local IRB approval for applicable work.

When does the program expect an IND or IDE to be submitted for the later CTA?

The opportunity highlights that the later Clinical Trial Award requires an IND or IDE (when applicable) to be submitted before the CTA application is submitted, which is why CTDA recipients are encouraged to advance IND/IDE preparations during the CTDA year.

How many awards were anticipated and what was the estimated total funding?

The program anticipated making about four awards, with an estimated total funding level of $640,000.

Is cost sharing or matching required?

No. The opportunity states that it did not require cost sharing or matching.

Who was the awarding agency for this opportunity?

The opportunity was offered by the Department of the Army, USAMRAA.

What is the Funding Opportunity Number for this CTDA?

The Funding Opportunity Number is W81XWH-11-GWIRP-CTDA.

What type of funding instrument was used?

The opportunity was described as a discretionary grant/cooperative agreement.

What was the category of this funding opportunity?

The opportunity was listed under the Science and Technology / R&D category.

What were the key dates for the FY11 application window?

The application window opened May 5, 2011. The original and current closing date was August 24, 2011. The opportunity archive date was September 23, 2011.

What was the stated eligibility for applicants?

Eligibility was listed as unrestricted (open to any entity type), subject to any additional eligibility notes in the full text.

Can an applicant submit more than one CTDA application?

Yes. Investigators were allowed to submit multiple applications as long as each application addressed a different future trial concept.

Can a single CTDA application cover planning for multiple clinical trials?

No. Each application could request support for planning a single clinical trial.

What kinds of planning deliverables does the CTDA aim to produce?

The CTDA is intended to result in a trial-ready package that has the key pieces needed for execution and rigorous review, such as a well-developed protocol and design, an assembled team and collaborations, a concrete recruitment plan for an appropriately defined cohort of ill Gulf War veterans, operational systems for QA/QC and data management, and a detailed statistical analysis plan, along with advanced steps toward required regulatory submissions when applicable.

What is the CTDA best suited for in practical terms?

It is best suited for Gulf War Illness intervention concepts that are already sufficiently mature to justify a Phase II or Phase III trial concept, but still need the full set of protocols, teams, recruitment pipelines, regulatory steps, and operational systems put in place before a large clinical trial can responsibly begin.