DoD Neurofibromatosis Clinical Trial Award | Apply Online

Opportunity Summary:

The DoD Neurofibromatosis Clinical Trial Award (CTA) is a funding opportunity under the Department of the Army (USAMRAA) and the Congressionally Directed Medical Research Programs (CDMRP) Neurofibromatosis Research Program (NFRP). It is specifically designed to move promising neurofibromatosis (NF) and/or schwannomatosis interventions into human testing, with the expectation that supported projects could meaningfully improve treatment options or disease management. This mechanism has been in place since FY1999; by the time of this FY2010 announcement, 23 applications had been submitted historically and 6 had been recommended for funding, signaling that it is a competitive program geared toward well-justified, trial-ready studies.

A central requirement is that the proposed work must be an actual clinical trial, meaning a prospective study that enrolls human participants and tests an intervention for a measurable outcome. The announcement is broad about what counts as an intervention, explicitly including drugs, devices, behavioral approaches, surgical procedures, and other interventional strategies, as long as the study is designed to evaluate outcomes in human subjects. The award cannot be used for preclinical studies, and applications that are essentially laboratory or animal work are expected to be directed to other funding mechanisms instead. Each application is also limited to one clinical trial with a distinct study design, so applicants are expected to present a single, coherent protocol rather than multiple related trials bundled into one proposal.

The program emphasizes readiness and rigor. Applicants are required to include relevant preliminary data or unpublished results from the Principal Investigator (PI) and/or named collaborators that directly support the proposed trial. Beyond data, the trial must be grounded in a sound scientific rationale built from critical analysis of the existing literature and logical reasoning about why the intervention should work and what the study will demonstrate. Operationally, the timeline matters: the clinical trial is expected to begin no later than 12 months after the award date, reflecting the program s focus on near-term clinical execution rather than long lead-time development.

Regulatory planning is treated as a make-or-break issue. If the trial involves an intervention that requires FDA authorization, the announcement expects Investigational New Drug (IND) or Investigational Device Exemption (IDE) materials to be submitted or approved prior to the grant application, particularly when the study is intended to support an FDA filing. Even after an award is made, the Government reserves the right to withdraw or revoke funding if an IND or IDE is required but is not secured within 6 months of the award date. In practical terms, applicants need to demonstrate that they understand the regulatory pathway, have already initiated it, and can keep the trial on schedule.

From a study design and feasibility perspective, the CTA requires applicants to show they can actually enroll participants and complete the trial in a way that yields interpretable results. Applications must demonstrate access to an appropriate volunteer population and explain how accrual targets will be met, including consideration of how existing standards of care could affect recruitment, enrollment decisions, or the available pool of participants. The announcement also calls for clearly defined endpoints that match the trial objectives, along with a detailed statistical analysis plan. A power analysis and sample size justification are expected so reviewers can see that the study is adequately sized to answer its primary questions rather than being underpowered or exploratory without a clear path to interpretation.

Project management capacity is another explicit expectation. The CTA requires inclusion of a study coordinator (or coordinators) to manage regulatory submissions and approvals (such as IRB and Human Subjects Research Review Board processes), coordinate activities across participating sites in multi-site trials, and support participant accrual. In addition, applicants must demonstrate institutional support, which typically means showing that the host organization has the infrastructure, oversight, clinical resources, and commitment needed to run the trial responsibly and efficiently.

In terms of basic opportunity details, this FY2010 CTA (Funding Opportunity Number W81XWH-10-NFRP-CTA) was offered as a discretionary research and development award, using either a cooperative agreement or grant instrument type. The program anticipated making about 2 awards with an estimated total funding level of $2.7 million, and it did not require cost sharing or matching. Eligibility was listed as unrestricted (open to any type of entity, subject to any clarifications in the full announcement). The opportunity was posted February 23, 2010, with an application closing date of May 20, 2010, and it was later archived June 19, 2010. For assistance, the announcement provided CDMRP and program contact points, including phone and email support for application access issues and electronic receipt help.

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Previous opportunity: DoD Neurofibromatosis Investigator Initiated Focused Research Award

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