DoD Joint Program Committee/Military Infectious Diseases Clinical Study Award | Apply Online

Opportunity Summary:

The DoD Joint Program Committee-2/Military Infectious Diseases Clinical Study Award (CSA) is a Department of Defense funding opportunity designed to move promising wound infection solutions into human testing, specifically for combat-related or trauma-induced wound infections and their downstream complications. The program is built around translation: it is meant to take therapies, interventions, or in vitro diagnostic tools that have already shown convincing performance in relevant animal models and push them into early clinical development so they can be evaluated for safety and early signals of effectiveness in real-world, military-relevant scenarios.

What this award will fund is narrowly defined. Applicants must propose either one early-phase clinical trial (Phase 0, Phase I, or Phase II, including first-in-human or proof-of-concept work) or one clinical investigation of an in vitro diagnostic (IVD) medical device, covering Class I through Class III device testing. The core requirement is that the funded work must involve human subjects (for clinical trials) or human specimens (for IVD investigations) and must be structured to produce measurable outcomes tied to safety, effectiveness, and/or efficacy. The goal is to generate the kind of clinical evidence that accelerates a product or approach toward practical clinical use in settings where traumatic wounds and infection risk are high.

At the same time, the program draws a hard line around what is not allowed. Phase III clinical trials intended for full FDA licensure of a drug or definitive FDA clearance testing for a device or assay are explicitly prohibited under this announcement. Preclinical research is also not an allowable use of funds under this mechanism; investigators who are still in the animal-model or preclinical stage are directed to apply instead to the separate FY17 JPC-2/MIDRP Applied Research Award. In other words, the CSA is meant for teams that are ready to operate in the clinical space now, not to generate foundational preclinical evidence.

The application expectations reflect that clinical-readiness focus. Proposals must include relevant preliminary data, and any unpublished data must come from the PI team, collaborators, or subawardees named in the application. Applicants are expected to present a strong scientific rationale grounded in critical analysis of the literature and logical reasoning that supports why the intervention or diagnostic should work in the target population. A practical feasibility case is required as well: teams must document that they have access to the drug, compound, device, assay, or other materials needed, and that the quality and manufacturing controls match FDA-appropriate standards for the product and development stage (for example, GLP, GMP, and Quality System Regulation, as applicable). They also need to show that an appropriate human subject population (or specimen resources for IVD studies) is available and accessible so the study can realistically enroll and produce interpretable results.

Operational and methodological rigor is a major emphasis. Applicants should define clear endpoints appropriate for the trial or device investigation, provide a detailed statistical analysis plan, and include the statistical expertise needed to justify the design. A power analysis and sample size projections are expected so reviewers can see that the study is properly sized to answer its main objectives. For clinical trials, the program also expects applicants to think through accrual logistics, including how enrollment targets will be met and how existing standards of care could affect recruitment or outcomes. On the compliance side, proposals should incorporate coordination resources such as study coordinators to help navigate Institutional Review Board (IRB) review and other regulatory processes and to manage multi-site operations and enrollment, when applicable. If the local IRB determines the study is greater than minimal risk, the protocol must identify an independent research monitor with expertise aligned to the specific risks involved.

A notable feature of the CSA is its support for collaboration through a Partnering PI option. Up to three PIs can participate, with one designated as the Initiating PI and the remaining as Partnering PIs, each receiving a separate award. The intent is to enable genuinely team-based projects where each PI provides substantial intellectual contribution and complementary capabilities, which can be especially important for studies that require clinical sites, microbiology and infectious disease expertise, device development, regulatory strategy, and biostatistics working together. Multi-disciplinary and multi-organizational projects are allowed, but participating organizations are expected to proactively address intellectual property and material transfer considerations so that administrative barriers do not derail execution.

For multi-institutional trials or device investigations, the program expects explicit planning for how collaborating institutions will communicate and transfer data, and how data, specimens, images, and other study materials will be handled throughout the project. In addition, multi-institutional efforts must include a separate intellectual and material property plan agreed to by all institutions involved. Across all projects, applicants must demonstrate institutional support and access to the resources needed to complete the work, reinforcing the program’s expectation that these studies are ready to launch and run smoothly soon after award.

Finally, the CSA places real weight on what happens after the study ends. Every application must include a Transition Plan describing how results will be advanced beyond the funded period, including what the next development step will be and where future funding might come from if the study is successful. This requirement is consistent with the program’s overall purpose: to produce actionable clinical evidence that moves a therapy or diagnostic closer to fieldable medical utility for preventing, detecting, diagnosing, or treating wound infections relevant to combat and traumatic injury.

Key administrative details from the posting include the funding opportunity number W81XWH-17-DMRDP-MID-CSA, administration through DOD-AMRAA, eligibility listed as unrestricted (open to various entity types, subject to any additional eligibility language in the full notice), an expected five awards, and a posted closing date of May 9, 2016 (as shown in the source listing). The award ceiling is listed as 0 in the posted record, which typically means applicants need to consult the full announcement documents for budget limits or constraints rather than relying on the summary field alone.

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