DoD DMRDP Military Infectious Diseases Clinical Trial Award | Apply Online

FAQs: DoD DMRDP Military Infectious Diseases Clinical Trial Award (FY14 MID CTA)

What is the FY14 MID CTA funding opportunity?

The Military Infectious Diseases Clinical Trial Award (FY14 MID CTA) is a Department of Defense (DoD) funding opportunity under the Defense Medical Research and Development Program (DMRDP), managed through the U.S. Army Medical Research Acquisition Activity (USAMRAA). It is associated with CFDA 12.420, Military Medical Research and Development, and is intended to move promising infectious disease therapies and diagnostics into early testing in humans.

What problem area is this award focused on?

This award specifically targets serious and debilitating combat-related or trauma-induced wound infections. The proposed work must clearly address the health care needs of Service Members and Veterans, with a focus on prevention and/or treatment improvements that are relevant to military medicine.

Does the clinical trial have to be conducted in a military population?

No. The clinical trial does not have to be conducted in a military population, as long as the product being tested and the evidence generated are clearly relevant to the health care needs of Service Members and Veterans and aligned with the military infectious disease mission described in the announcement.

What types of studies does this program support?

The program is focused on clinical translation and supports clinical trials and clinical testing in human subjects. It is designed to generate measurable evidence related to safety, effectiveness, and/or efficacy of a novel therapy or diagnostic in human patients.

Does this award support basic research or preclinical studies?

No. The scope is intentionally focused on clinical trials and clinical testing rather than basic or preclinical studies. The intent is to fund the step where an intervention that is already supported by appropriate prior evidence advances into well-designed human studies.

What phases of clinical development are allowed?

Supported studies may range from proof-of-concept and first-in-human efforts (including Phase 0) through Phase II drug trials. The program may also support clinical testing of Class I, II, or III medical devices.

Are Phase III trials or pivotal trials allowed?

No. Phase III drug trials aimed at FDA licensure are not allowed. Likewise, definitive pivotal testing intended to obtain FDA clearance for a device or assay is not allowed under this announcement.

What is the core requirement for how award funds must be used?

A defining requirement is that award dollars must directly support a clinical trial or clinical testing activity. This is defined by prospective enrollment of human subjects and evaluation of an intervention for a measurable outcome.

How does the announcement define an "intervention"?

The announcement uses a broad definition of intervention, which can include drugs, biologics, devices, procedures, rehabilitation modalities, behavioral interventions, and similar approaches, as long as they are tested in humans and outcomes reflect a direct effect on participants.

Does the program support diagnostics and biomarker-driven approaches?

Yes. The term "device" is broadened to include diagnostics, including in vivo or in vitro tests and biomarker-driven approaches, as long as they are clinically tested in human subjects with measurable outcomes.

How are in vitro diagnostics described in the opportunity?

In vitro diagnostics are framed in FDA-style terms and include reagents, instruments, and systems used to examine human specimens for diagnosis, determining health status, or supporting treatment and prevention decisions.

What regulatory requirements should applicants be prepared for?

Applicants must be prepared for regulatory requirements associated with human testing. If a drug is not FDA-approved for the proposed investigational use, an Investigational New Drug (IND) application may be needed. If an investigational device is not cleared or approved for the proposed clinical use, Investigational Device Exemption (IDE) requirements may apply.

Is there a deadline for obtaining IND or IDE documentation after award?

Yes. The announcement sets a strict expectation that if documented IND or IDE status is not obtained within six months of the award date, the DoD may terminate the award for failure to meet a material condition.

What does the IND/IDE requirement imply about project maturity?

It signals that competitive applications are expected to be mature and near-ready for clinical execution, with realistic plans and capabilities to meet regulatory milestones quickly after award.

What kind of preliminary data is expected in the application?

Proposals are expected to include preliminary data that directly support the clinical trial concept. This may include unpublished data generated by the principal investigator (PI), collaborators, or subawardees.

How important is the scientific rationale and literature support?

The trial must be grounded in a sound scientific rationale supported by critical analysis of the existing literature. The announcement emphasizes that proposals should not be based only on a promising idea; they should be backed by evidence and thoughtful justification.

What must applicants show regarding access to the intervention being tested?

Applicants must demonstrate access to the necessary intervention materials, such as the compound, device, assay components, or manufacturing supply chain required to conduct the clinical trial or clinical testing as proposed.

What does the program expect regarding access to a human subject population?

Applicants must show access to an appropriate human subject population and address recruitment feasibility, including how accrual targets will be met and how differences in standards of care could affect enrollment, comparators, or outcomes.

What clinical trial design elements are expected to be clearly specified?

Applications are expected to specify well-defined clinical endpoints, include a statistical analysis plan, demonstrate appropriate statistical expertise, and provide a power analysis with sample size projections tied to the study objectives.

What kind of results is the DoD looking for from funded studies?

The program is looking for interpretable, decision-quality clinical results that can guide the next development step, including evidence related to safety, effectiveness, and/or efficacy in human testing.

How should applicants address the potential impact of the proposed trial?

Proposals must explain how results could realistically improve prevention and/or treatment of combat-related or trauma-induced wound infections, in a way that is relevant to Service Members and Veterans.

Is project management and institutional support emphasized?

Yes. Strong project management and institutional support are treated as essential. Applicants are expected to document institutional commitment and access to facilities and resources needed to run the trial successfully.

Is a study coordinator required or expected?

The announcement indicates that applications should include a study coordinator (or coordinators) responsible for managing key operational needs such as moving the protocol through the local IRB and other regulatory processes, coordinating multi-site activities if applicable, and managing participant accrual.

What is a Transition Plan and why is it required?

A Transition Plan is required to describe what happens after the award period ends, including a credible path to continue development of the therapy or diagnostic and progress to the next stage of clinical development or commercialization. This reinforces the program's translational intent and interest in projects that will not stall after early clinical testing.

What funding mechanism is used for this opportunity?

This opportunity used a cooperative agreement mechanism. The emphasis on coordination, regulatory milestones, and transition planning reflects a hands-on approach where the government often expects substantial programmatic engagement to keep clinical work on track.

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

The announcement anticipated making about four awards, with an estimated total funding level of $11.4 million.

Who was eligible to apply?

Eligibility was listed as unrestricted, meaning a wide range of organizations could apply.

When was the opportunity posted and when did it close?

The opportunity was posted on June 4, 2013, with a final closing date of October 17, 2013. The archive date was November 3, 2013.

What is the practical purpose of this award within the development pipeline?

In practical terms, the award aims to fund the critical step between strong supporting evidence (including appropriate animal model results) and larger, later-stage regulatory trials. It is intended to de-risk and justify subsequent development efforts by producing credible early human data.