DoD Ovarian Cancer Clinical Development Award | W81XWH 18 OCRP CDA

Opportunity Information: Apply for W81XWH 18 OCRP CDA

The DoD Ovarian Cancer Clinical Development Award (OCRP CDA; Funding Opportunity Number W81XWH-18-OCRP-CDA) is a translational funding mechanism run through the Department of Defense (Dept. of the Army, USAMRAA) designed to move promising ovarian cancer advances into real clinical use quickly. Its central focus is on accelerating the clinical introduction of medical products and technologies that directly target ovarian cancer biology, with an emphasis on near-term clinical impact. Projects are expected to be beyond basic discovery and positioned at the point where a product, tool, or intervention is ready to be evaluated in people or in clinically anchored settings, such as studies that support or refine clinical trial efforts.

A key feature of this award is that applicants must already have strong proof-of-concept evidence for the proposed product or approach. That proof can be shown through a prototype, a preliminary version of a device or test, or other data demonstrating potential utility. Because the program is meant to push work into clinical development rather than earlier validation, preclinical animal studies are not allowed under this mechanism. Instead, the program supports small-scale, early-stage human research, including Phase 0 and Phase 1 clinical trials, studies that enrich or enable clinical trials (for example, biomarker-driven stratification or correlative studies), and projects that are related to or associated with ongoing or completed clinical trials. The application must include relevant supporting data, whether published or unpublished, that clearly justify the study rationale and demonstrate readiness for the proposed clinical development step.

The application is expected to make a convincing case that the study can actually be executed as proposed. That means demonstrating access to an appropriate human participant population or to the necessary human anatomical samples in a way that will produce meaningful outcomes. Applicants must address feasibility directly, including how they will meet enrollment or accrual targets and what infrastructure or partnerships support recruitment and sample access. In parallel, the application needs to document that the required drug, compound, device, assay materials, or other key resources are available and accessible for the duration of the project, so reviewers can see that the effort will not stall due to supply, licensing, manufacturing, or procurement barriers.

Strong clinical study design is a major review expectation. Projects should include clearly defined, clinically appropriate endpoints, along with a detailed statistical analysis plan. This includes a power analysis and sample size justification that matches the study objectives and allows a clear interpretation of results. The program also requires a transition plan describing what comes next after the award ends, including likely funding paths and practical resources needed to progress to the next development stage. This could involve advancing to a larger clinical trial, moving toward regulatory steps, or planning for delivery into the military or civilian healthcare marketplace. In other words, the award is not intended to end with a standalone pilot result; it is intended to produce a concrete springboard to the next development milestone.

For applicants proposing clinical trials, there is an optional nested Early-Career Investigator (ECI) component meant to build the next generation of ovarian cancer clinical investigators. One ECI may be included in an application, and that investigator must be within five years of their last postdoctoral position (for PhD pathways) or clinical fellowship (for MD pathways), or an equivalent milestone, as of the full application deadline, and must meet specific eligibility requirements. When an ECI is included, the application qualifies for a higher direct cost cap, and the primary PI is expected to provide mentorship to the ECI in the conduct of clinical trial research.

The opportunity also emphasizes rigor and transparency in study design and reporting, referencing widely recognized standards that promote reproducibility and translational reliability (for example, the Landis et al. Nature 2012 recommendations on transparent reporting). Additionally, proposed work must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the broader American public, reflecting the DoD mission context for its medical research investments.

From an administrative and regulatory standpoint, any DoD-funded research involving human subjects, human anatomical substances, or human cadavers requires review and approval by the USAMRMC Office of Research Protections Human Research Protection Office (HRPO) before research can begin. This HRPO review is in addition to local IRB or ethics committee review, and local IRB/EC approval is not required at the time of application submission. However, applicants need to plan for HRPO timelines, with at least 2 to 3 months recommended for regulatory review and approval. Protocols should be written to align specifically with the DoD-supported scope of work, because submitting broader protocols can trigger more extensive DoD compliance review and potentially require modifications to meet DoD-specific human research protections requirements.

Awards under this announcement are made as assistance agreements, meaning either grants or cooperative agreements, with the choice driven by how much substantial involvement the DoD anticipates during performance. If substantial involvement is expected (such as active collaboration or participation), a cooperative agreement is used; if not, a grant is used. The program also signals an expectation that data, information, and research resources generated through funded projects will be made available to the broader research and advocacy communities and to the public, consistent with CDMRP sharing principles.

Funding levels are capped in direct costs at up to $600,000 total for the period of performance for standard awards, and up to $800,000 total when the optional nested Early-Career Investigator is included. The opportunity was open broadly to eligible applicants without restriction by organization type (subject to any clarifications in the full announcement). The original closing date for the FY18 cycle was August 8, 2018, with an anticipated number of awards around four, and awards intended to be made no later than September 30, 2019.

• 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 Ovarian Cancer Clinical Development 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 Apr 11, 2018.
• Applicants must submit their applications by Aug 08, 2018. (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 4 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.

Apply for W81XWH 18 OCRP CDA

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