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 The application must include relevant supporting data, whether published or unpublished, that clearly justify the study rationale and demonstrate readiness for the proposed clinical development step.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.Apply for W81XWH 18 OCRP CDA
- 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.
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Frequently Asked Questions (FAQs) - DoD Ovarian Cancer Clinical Development Award (OCRP CDA)
What is the DoD Ovarian Cancer Clinical Development Award (OCRP CDA)?
The OCRP Clinical Development Award (Funding Opportunity Number W81XWH-18-OCRP-CDA) is a Department of Defense translational funding mechanism intended to move promising ovarian cancer advances into real clinical use quickly. It prioritizes near-term clinical impact and supports work that is positioned for evaluation in people or in clinically anchored settings.
What is the main purpose or focus of this award?
The central focus is accelerating the clinical introduction of medical products and technologies that directly target ovarian cancer biology. The program is designed to support projects that are beyond basic discovery and are ready for clinical development steps that can lead to practical use in healthcare.
What kind of projects are considered a good fit?
Projects that are ready to be evaluated in humans (or tightly connected to clinical trial efforts) are the intended fit. Examples described include small-scale early-stage human research (including Phase 0 and Phase 1 clinical trials), studies that enrich or enable clinical trials (such as biomarker-driven stratification or correlative studies), and projects associated with ongoing or completed clinical trials.
Are basic discovery or early validation projects appropriate for this mechanism?
No. The award is intended for clinical development rather than early discovery or earlier-stage validation. Applications are expected to demonstrate readiness for a clinical development step.
Is proof-of-concept required at the time of application?
Yes. A key feature of the award is that applicants must already have strong proof-of-concept evidence for the proposed product or approach. The proof can be demonstrated through a prototype, a preliminary device/test, or other data showing potential utility.
What types of supporting data can be used to justify readiness?
The application must include relevant supporting data, published or unpublished, that justifies the study rationale and shows the proposed work is ready for the targeted clinical development step.
Are preclinical animal studies allowed under this award?
No. Preclinical animal studies are explicitly not allowed under this mechanism. The program supports early-stage human research and clinically anchored studies instead.
What human research activities does the award support?
The mechanism supports small-scale, early-stage human research, including Phase 0 and Phase 1 clinical trials. It also supports studies that support, refine, enrich, or enable clinical trial efforts (including biomarker-driven stratification and correlative studies) and projects tied to ongoing or completed clinical trials.
Does the award require access to human participants or human samples?
Yes. The application is expected to demonstrate feasibility by showing access to an appropriate human participant population and/or access to necessary human anatomical samples, with a plan that supports meaningful outcomes.
How should feasibility be addressed in the application?
Applicants are expected to address feasibility directly, including how enrollment or accrual targets will be met and what infrastructure or partnerships support recruitment and/or sample access.
Do applicants need to show that key study resources will be available?
Yes. The application needs to document that required drugs, compounds, devices, assays, materials, or other key resources are available and accessible for the duration of the project, so the work is not delayed by supply, licensing, manufacturing, or procurement barriers.
What expectations are there for clinical study design?
Strong clinical study design is a major review expectation. Projects should include clearly defined, clinically appropriate endpoints and a detailed statistical analysis plan.
Is a statistical analysis plan and power analysis required?
Yes. The program expects a statistical analysis plan that includes a power analysis and sample size justification aligned with the study objectives to enable clear interpretation of results.
Is a transition plan required, and what should it cover?
Yes. The award requires a transition plan describing what will happen after the award ends, including likely funding paths and practical resources needed to reach the next development stage. Examples include advancing to a larger clinical trial, moving toward regulatory steps, or planning for delivery into military or civilian healthcare marketplaces.
Is the award intended to fund a standalone pilot study?
No. The intent is not to end with a standalone pilot result. The award is meant to provide a concrete springboard to the next development milestone.
What is the optional nested Early-Career Investigator (ECI) component?
For applicants proposing clinical trials, the mechanism includes an optional nested ECI component intended to help develop the next generation of ovarian cancer clinical investigators. One ECI may be included in an application.
Who is eligible to be included as an Early-Career Investigator (ECI)?
An ECI must be within five years of their last postdoctoral position (for PhD pathways) or within five years of clinical fellowship (for MD pathways), or an equivalent milestone, as of the full application deadline, and must meet specific eligibility requirements.
How does including an ECI affect the budget cap?
When the optional nested ECI is included, the application qualifies for a higher direct cost cap compared to the standard award.
What is expected of the primary PI when an ECI is included?
The primary PI is expected to provide mentorship to the ECI in the conduct of clinical trial research.
What are the direct cost limits for this funding opportunity?
Direct costs are capped at up to $600,000 total for the period of performance for standard awards, and up to $800,000 total when the optional nested ECI component is included.
What kind of award instrument is used (grant vs. cooperative agreement)?
Awards are made as assistance agreements, meaning either grants or cooperative agreements. The choice depends on whether substantial DoD involvement is anticipated during performance: cooperative agreements are used when substantial involvement is expected, and grants are used when it is not.
Are there expectations for data and resource sharing?
Yes. The opportunity indicates 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.
Does the opportunity emphasize rigor and transparency in reporting?
Yes. The award emphasizes rigor and transparency in study design and reporting and references widely recognized standards that promote reproducibility and translational reliability (for example, the Landis et al. Nature 2012 recommendations on transparent reporting).
How does the DoD mission context factor into relevance requirements?
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.
What human research approvals are required before work can begin?
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.
Is HRPO review in addition to local IRB or ethics review?
Yes. HRPO review is in addition to local IRB or ethics committee review.
Is local IRB/EC approval required at the time of application submission?
No. Local IRB/ethics committee approval is not required at the time of application submission, based on the information provided.
How long should applicants plan for HRPO review?
Applicants are advised to plan for HRPO timelines, with at least 2 to 3 months recommended for regulatory review and approval.
How should protocols be scoped to reduce delays in DoD review?
Protocols should be written to align specifically with the DoD-supported scope of work. Submitting broader protocols can trigger more extensive DoD compliance review and may require modifications to meet DoD-specific human research protections requirements.
Who could apply (organization type restrictions)?
The opportunity was described as open broadly to eligible applicants without restriction by organization type, subject to any clarifications in the full announcement.
What was the original closing date and expected award timing for the FY18 cycle?
The original closing date for the FY18 cycle was August 8, 2018. Awards were intended to be made no later than September 30, 2019.
How many awards were anticipated?
The anticipated number of awards was around four.
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| DoD Ovarian Cancer Pilot Award Apply for W81XWH 18 OCRP PA Funding Number: W81XWH 18 OCRP PA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Ovarian Cancer Investigator-Initiated Research Award Apply for W81XWH 18 OCRP IIRA Funding Number: W81XWH 18 OCRP IIRA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Ovarian Cancer, Ovarian Cancer Academy- Early-Career Investigator Award Apply for W81XWH 18 OCRP OCA Funding Number: W81XWH 18 OCRP OCA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
| DoD Ovarian Cancer, Omics Consortium Development Award Apply for W81XWH 18 OCRP OMCDA Funding Number: W81XWH 18 OCRP OMCDA Agency: Department of Defense, Dept. of the Army -- USAMRAA Category: Science and Technology and other Research and Development Funding Amount: Case Dependent |
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