DoD Epilepsy, Longitudinal Risk Factors Award | W81XWH 18 ERP LRFA

Frequently Asked Questions (FAQs): DoD Epilepsy, Longitudinal Risk Factors Award (FY18 ERP LRFA)

What is the DoD Epilepsy, Longitudinal Risk Factors Award (FY18 ERP LRFA)?

The FY18 ERP Longitudinal Risk Factors Award (opportunity number W81XWH 18 ERP LRFA) is a Department of Defense (DoD) research funding opportunity to improve understanding of post-traumatic epilepsy (PTE) that develops after traumatic brain injury (TBI). The program is designed to fund one large, prospective, longitudinal epidemiological study that follows a defined cohort over time to characterize how PTE emerges, progresses, and affects patients.

What is the main goal of this funding opportunity?

The main goal is to generate longitudinal, real-world evidence about the natural history of PTE after TBI, including how and when epilepsy develops, how it changes over time, and which measurable factors influence risk and outcomes. The work is intended to be relevant to military Service members, Veterans, and civilians.

How many awards are expected to be made?

The funding opportunity indicates an expected number of awards of 1, meaning it is intended to support a single major study rather than multiple smaller projects.

What type of study is required under this award?

This award requires a large-scale, prospective, longitudinal epidemiological study. The required focus area is longitudinal studies of the natural history of PTE, with follow-up over time to observe meaningful outcomes and changes rather than short-term snapshots.

What does the opportunity mean by "longitudinal" in this context?

In this context, longitudinal means following the same defined group of individuals over time with repeated outcome ascertainment. The intent is to track the natural evolution of post-traumatic epileptogenesis and PTE outcomes, including timing of onset, disease course, and how comorbidities and quality of life change over time.

What population should be studied?

The study should follow a defined group of people (a cohort) who can be used to assess and characterize the relationship between TBI and later PTE. The opportunity emphasizes relevance to military Service members and Veterans while also recognizing civilian relevance.

What must applicants explain about TBI in the cohort?

Applicants are expected to clearly explain how they will assess and characterize the relationship between TBI and later PTE, including the types and nature of TBIs represented in the study population. Examples include TBI severity, mechanism of injury, and relevant clinical features.

What must applicants explain about how PTE will be measured over time?

Applicants should describe how the study will capture the onset and course of epilepsy after injury, including longitudinal outcome ascertainment and sufficient follow-up to observe PTE development, progression, and related outcomes.

What kinds of outcomes are considered high priority?

Examples of high-priority outcomes include seizure frequency and severity; comorbidities (such as depression, sleep disorders, functional impairments, or other major illnesses); latency between TBI and development of PTE; mortality; treatment patterns or treatment response as observed in real-world care (not as part of a clinical trial); and overall quality of life for individuals living with PTE.

Is the award intended to support a clinical trial?

No. Research centered on interventional clinical trials, particularly pharmacological interventions, is strongly discouraged. The program is oriented toward observational, real-world, longitudinal characterization rather than testing interventions.

Is animal research allowed under this mechanism?

Animal research is not intended under this mechanism. The focus is on humans and on observational longitudinal studies related to PTE after TBI.

What kinds of study designs are discouraged?

Proposals that fall outside the longitudinal natural history focus are strongly discouraged. In particular, animal studies and interventional clinical trials (especially pharmacological interventions) are not aligned with the stated intent of the mechanism.

Are multi-site studies or consortia allowed?

Yes. Interdisciplinary research teams and multi-site consortia are explicitly encouraged, reflecting the infrastructure and expertise often needed to execute a comprehensive longitudinal epidemiological study.

What types of data or measures does the announcement encourage teams to include?

The announcement encourages evaluating the feasibility and value of combining multiple kinds of outcome measures, such as neuropsychological testing, imaging, and genomic data, alongside clinical and epidemiologic variables.

Are preliminary data required?

Yes. Preliminary data are required under this mechanism.

Do applicants need to already have a cohort identified?

Yes. Applicants must have expedited access to an already identified, suitable cohort capable of supporting the study hypotheses. This favors teams that already have a cohort assembled or have firm agreements and pathways to access an existing cohort (for example, through established registries, healthcare systems, or longitudinal datasets), rather than proposals that would spend much of the award period building a cohort from scratch.

What application components are specifically required?

Applicants must submit a Preproposal Narrative and include a Longitudinal Studies Research Statement addressing how the project will function as a longitudinal study (for example, follow-up schedule, retention strategy, outcome ascertainment over time, and handling of missing data). A statistical plan is also required, along with identification of personnel appropriately qualified to carry it out.

What should be included in the Longitudinal Studies Research Statement?

Based on the announcement, it should address key operational and analytic features of a longitudinal study, including the follow-up schedule, participant retention strategy, how outcomes will be ascertained over time, and how missing data will be handled.

Is a statistical plan required?

Yes. A statistical plan is required, and applicants must identify personnel appropriately qualified to carry out the statistical work, consistent with the expectation of rigorous, well-powered epidemiological analysis and careful longitudinal modeling.

What is the funding mechanism (grant vs cooperative agreement)?

Funding is provided as an assistance agreement, meaning the award will be made as either a grant or a cooperative agreement depending on anticipated DoD involvement. If substantial DoD involvement is expected (such as collaboration or participation in the research), a cooperative agreement would be used; if not, a standard grant would be used.

What is the maximum funding amount and project length?

The anticipated direct costs are capped at $2.5 million for the full period of performance, and the maximum project period is 4 years.

Who is eligible to apply?

Eligibility is broadly open to organizations. The key investigator requirement is that the named Principal Investigator (PI) must be at or above the level of Assistant Professor (or equivalent).

Which DoD office sponsors this opportunity?

The sponsoring office is within the Department of Defense, Department of the Army, USAMRAA.

What is the CFDA number and activity category for this opportunity?

The activity category is research and development under CFDA 12.420.

When was the opportunity posted and when did it close?

The opportunity was originally posted on June 11, 2018, and the original closing date was October 4, 2018.

What should applicants emphasize to align with reviewer expectations?

Applicants should tightly align with the required focus on longitudinal natural history of PTE after TBI, clearly define and justify the cohort, explain TBI characterization and PTE outcome capture over time, propose meaningful longitudinal follow-up, and provide the required narratives and rigorous statistical approach. Proposals outside this longitudinal observational scope are discouraged.