DoD Tuberous Sclerosis Complex, Clinical Translational Research Award

Background
The CTRA supports studies that will move promising, well-founded preclinical and/or clinical research findings closer to clinical application, including diagnosis, prognosis, or treatment of TSC. The proposed research must be relevant to active-duty Service Members, Veterans, military beneficiaries, and/or the American public. The FY24 TSCRP Clinical Translational Research Award (CTRA) encourages applications in mechanistic studies, animal model development, biomarkers, therapeutics, and patient-centered studies that address specific focus areas related to TSC.

Grant Details
The CTRA supports studies moving from preclinical to clinical research and/or the reverse; analyzing human anatomical substances and/or data associated with completed clinical trials to understand the mechanism of action or improve diagnosis, prognosis, or treatment. It also includes advancing clinical trial readiness through biomarker development, clinical endpoints, and validation of pharmacokinetics/pharmacodynamics.

Pilot clinical trials are supported for limited clinical testing of a novel intervention to produce information on diagnostic or therapeutic effectiveness. Additionally, new studies improving clinical care of TSC encompassing the analysis of existing real-world clinical practice data to develop/improve guidelines for better outcomes in defined areas relevant to the FY24 TSCRP focus areas.

Eligibility Requirements
Extramural and Intramural organizations are eligible to apply, including foreign or domestic organizations, for-profit and non-profit organizations, and public entities. Independent investigators at or above the level of Assistant Professor (or equivalent) are eligible to be named as a PI.

Advanced practice providers or nurses are also eligible to be named as a PI for studies addressing improving clinical care of TSC.

Period of Performance
Awards supported with FY24 funds will be made no later than September 30, 2025. The anticipated direct costs budgeted for the entire period of performance for an FY24 CTRA should not exceed $1,000,000.

The anticipated direct costs budgeted for the entire period of performance for an FY24 TSCRP CTRA with Partnering PI Option Award should not exceed $1,150,000.

Grant Value
$3.4M is expected to fund approximately two Clinical Translational Research Award applications.