DoD Tuberous Sclerosis Complex Clinical Research Award | Apply Online

Opportunity Summary:

The DoD Tuberous Sclerosis Complex Clinical Research Award (CRA) is a funding opportunity under the Department of the Army (USAMRAA) and the Tuberous Sclerosis Complex Research Program (TSCRP) aimed at advancing research that can meaningfully improve the treatment or management of tuberous sclerosis complex (TSC). First introduced in FY08, the FY10 version of this mechanism prioritizes clinical and translational research, especially projects that directly involve human subjects. While the emphasis is clearly on human-focused work, the program also notes that preclinical studies will be considered, particularly when they are positioned to support translation toward patient impact. The overall intent is to move scientifically solid ideas closer to real-world clinical benefit, and the program explicitly encourages interdisciplinary teamwork to bring fresh perspectives into the TSC field.

A core expectation of this award is that applications include preliminary data. The announcement specifies that unpublished results from the Principal Investigator (PI) and/or named collaborators must be provided if they are relevant to the proposed project. In practice, this means proposals are not meant to be purely speculative; they should be grounded in evidence that the approach is feasible and promising. Alongside preliminary data, the application needs a strong scientific rationale built on logical reasoning and a critical review of existing literature, signaling that reviewers will weigh how well the project is justified and how convincingly it builds on what is already known.

Collaboration is a major feature of this opportunity, and applicants may include an optional "qualified collaborator" to strengthen the project. The program strongly supports partnerships that are genuinely interdisciplinary, introduce new investigators to TSC research, or add expertise that would not normally exist in a single laboratory or clinical team. Importantly, collaborations that meet specific criteria can qualify an application for a higher level of funding (as referenced in the full announcement). To be considered a qualifying collaboration, the PI must include a formal Statement of Collaboration explaining who the collaborator is and how the collaboration meets the program's requirements, and the collaborator must also provide a letter describing their role. The collaboration must be essential to the project, meaning the work could not be accomplished without the collaborator's unique contribution. Additionally, either the PI or collaborator must already have TSC research experience demonstrated through publications and/or prior funding, the collaborator must be at least an Assistant Professor (or equivalent), and they must commit a minimum of 10 percent effort with that contribution reflected in the budget. The announcement also clarifies what does not count as a qualifying collaboration, such as simply providing reagents, acting as a service provider or core facility for routine lab or statistical work, or arrangements where the project could realistically be completed within a single PI's lab.

The award supports one of two study categories per application, and applicants must choose only one. The first category is clinical and translational research studies, which can include direct clinical research involving human subjects, research using human-origin materials (such as tissues or specimens), studies of cognitive phenomena, biomarker research, correlative studies linked to existing clinical trials, and other translational work that still keeps a strong emphasis on human relevance. Although human subject work is preferred, preclinical studies are still eligible for consideration. The announcement also points applicants to a set of translational research "pathways" (hosted by the National Cancer Institute) as a resource for thinking through how to move from discovery toward clinical goals, suggesting that the program values clear translational planning rather than disconnected experiments.

The second category is clinical trials, defined here as prospective patient accrual studies that test an intervention (such as a drug, device, behavioral approach, surgical procedure, or other intervention) in humans and measure outcomes. If an applicant proposes a clinical trial, the program imposes additional readiness and documentation requirements. The clinical trial is expected to begin within 12 months of the award date, which signals that the DoD wants trials that are close to launch rather than early-stage concepts. A full clinical protocol must be submitted by the application deadline in addition to the project narrative, and it will be reviewed separately using clinical-trial-specific criteria. Applications that propose a trial but fail to include the required protocol will be administratively withdrawn, meaning they will not proceed to review. The announcement also limits each application to a single clinical trial with a distinct study design, reinforcing the idea that the submission should be focused and operationally realistic.

Regulatory readiness is another key theme for clinical trial proposals. When the proposed work requires an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE), the announcement expects the IND/IDE to be submitted or approved before the grant application is submitted, especially when the study supports an FDA submission pathway. The government also reserves the right to withdraw or revoke funding if the required IND/IDE is not obtained within six months after the award date. Taken together, these requirements indicate that trial proposals must be close to regulatory clearance and capable of moving quickly into patient enrollment.

From an administrative standpoint, this opportunity was posted February 16, 2010, with an application closing date of June 25, 2010 (archived July 25, 2010). It was offered as a discretionary funding opportunity using a Cooperative Agreement/Grant instrument, categorized under science and technology and other research and development. The estimated total funding amount listed is $1.8 million, with an expected number of awards of one, suggesting a competitive program designed to fund a single, relatively substantial project rather than many smaller awards. Eligibility is listed as unrestricted, meaning it is open to many entity types, subject to any additional eligibility clarifications in the full text. The CFDA number provided is 12.420 (Military Medical Research and Development), and there is no cost sharing or matching requirement noted.

In short, the DoD TSCRP Clinical Research Award is built for well-justified, data-supported projects that can move the needle for TSC patients, with a strong preference for human-subjects research and a structured pathway for funding either a focused clinical/translational study or a single, launch-ready clinical trial. It rewards meaningful, effort-backed collaborations, and it sets clear expectations for feasibility, documentation, and regulatory preparedness, especially for trials intended to start quickly after award.

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Previous opportunity: U.S. Nuclear Regulatory Commission, Office of Nuclear Regulatory Research Announcement of Opportunity, Fiscal Year 2010

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