DOD Tuberous Sclerosis Complex, Clinical Translational Research Award | W81XWH 21 TSCRP CTRA

Frequently Asked Questions (FAQs)

What is the Tuberous Sclerosis Complex (TSC) Clinical Translational Research Award (CTRA)?

The TSC Clinical Translational Research Award (CTRA) is a Department of Defense (DoD) funding opportunity offered through the U.S. Army Medical Research Acquisition Activity (USAMRAA). It supports research designed to move strong preclinical and/or clinical findings closer to real-world clinical use for people affected by Tuberous Sclerosis Complex (TSC).

What is the main goal of this award?

The central goal is translational momentum: taking research that is already promising and well-grounded and advancing it toward practical clinical application. The focus is on bridging the gap between discovery and patient impact rather than supporting early exploratory ideas without a clear clinical path.

What kinds of impacts or outcomes is the program aiming for?

The opportunity emphasizes work that could lead to tangible improvements for people with TSC, including improved diagnosis, better prognostic tools, and new or optimized treatments. The overall priority is work positioned to improve patient care.

What does "clinical translational" mean in the context of this award?

In this context, "clinical translational" refers to studies that directly connect preclinical evidence and clinical application, or that strengthen the tools and evidence needed to move candidate interventions into practical clinical settings. The program highlights projects that meaningfully bridge discovery and clinical use.

Are early-stage exploratory or discovery projects a fit for this award?

Based on the description provided, the emphasis is not on early exploratory ideas without a clear path to the clinic. The award is positioned for teams with a credible foundation of preclinical or clinical evidence who can propose the next concrete translational step.

What types of studies are specifically highlighted as a good fit?

The announcement highlights several categories of work that fit well: (1) studies that move from preclinical research into clinical research (or back the other way), including analysis of human anatomical substances or human-derived data linked to completed clinical trials; (2) efforts to prepare therapies and interventions for clinical trials by developing and refining enabling tools like biomarkers and clinically meaningful endpoints, including PK/PD validation; and (3) pilot clinical trials, including behavioral interventions.

Does the opportunity support research using existing clinical trial samples or datasets?

Yes. The description explicitly includes correlative studies that use previously collected clinical trial samples or datasets (tied to completed trials) to identify signals related to why a therapy worked, which patients benefited most, or what biological pathways are linked to outcomes.

What are correlative studies in this program context?

Correlative studies, as described, are analyses that leverage clinical trial samples or data to connect biological signals to clinical outcomes. Examples mentioned include understanding why a therapy worked, determining who benefited most, and identifying pathways linked to outcomes.

Can projects move from clinical research back to preclinical research?

Yes. The opportunity notes studies that move from preclinical into clinical research or back the other way, indicating bidirectional translational work is within scope when it advances readiness for clinical impact.

Does the award support developing biomarkers and endpoints for trials?

Yes. A major highlighted category is getting therapies and interventions ready for clinical trials by developing and refining tools trials need, including biomarkers and clinically meaningful endpoints.

What is PK/PD, and is it supported under this award?

PK/PD refers to pharmacokinetics and pharmacodynamics, which are used to understand dose, exposure, biological effect, and whether a therapy engages its intended target. The opportunity states that validating PK/PD is included within scope as part of clinical trial readiness efforts.

Are pilot clinical trials allowed under this mechanism?

Yes. The description states that the mechanism can support pilot clinical trials, including behavioral interventions. These are generally smaller, carefully designed early-stage trials intended to assess feasibility, initial signals of benefit, or implementation considerations.

Are behavioral interventions considered in-scope?

Yes. Behavioral interventions are specifically mentioned as included within the types of pilot clinical trials supported.

Who is offering and administering this funding opportunity?

The Department of Defense (DoD) is offering the opportunity, and it is administered through the U.S. Army Medical Research Acquisition Activity (USAMRAA).

What is the Funding Opportunity Number for this award?

The Funding Opportunity Number listed is W81XWH-21-TSCRP-CTRA.

What CFDA number is associated with this opportunity?

The listing places the opportunity under CFDA 12.420, categorized as research and development.

What type of funding instrument(s) could be used for awards?

Awards could be made as either grants or cooperative agreements. The description notes that cooperative agreements may involve more substantial DoD involvement, depending on the nature of the work.

What does it mean that awards may be grants or cooperative agreements?

Based on the information provided, it means some funded projects could be structured as standard grants, while others could be cooperative agreements where DoD involvement is more substantial. Which structure applies may depend on the project and program needs.

Who was eligible to apply?

Eligibility was described as unrestricted and open to any type of entity, subject to any additional eligibility language that may have been included in the full announcement.

How many awards were expected?

The expected number of awards was two.

When was the opportunity posted and when did it close?

The opportunity shows a creation date of April 1, 2021, and an original closing date of July 8, 2021.

Was there a stated maximum award amount (award ceiling)?

The listing shows an award ceiling of 0. This typically indicates the ceiling was not specified in the summary record, and applicants would need to consult the full solicitation for budget limits, funding availability, and other constraints.

Is the award ceiling of 0 a real budget cap?

Not necessarily. The provided description indicates that a ceiling of 0 usually means the ceiling was not specified in the summary listing rather than implying that no funding is available. The full solicitation would be the place to confirm any actual budget limits or constraints.

What kind of research teams is this opportunity designed for?

This opportunity targets research teams that already have credible preclinical or clinical evidence and can propose the next translational step that brings TSC research closer to practical clinical tools or interventions.

What is the overall emphasis in DoD priorities reflected by this opportunity?

The priorities described favor work positioned to improve patient care by strengthening trial readiness, validating measures and biomarkers, making smart use of existing clinical trial resources, and conducting well-justified pilot testing in clinical settings, including non-pharmacologic and behavioral approaches.

Is this described as a discretionary funding opportunity?

Yes. The information provided describes it as a discretionary funding opportunity.