DoD Tuberous Sclerosis Complex Clinical Translational Research Grant

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. Projects supported by this award mechanism may include, but are not limited to:

·        Studies moving from preclinical to clinical research and/or the reverse; or analyzing human anatomical substances and/or data associated with completed clinical trials to understand the mechanism of action, or to improve diagnosis, prognosis, or treatment.

·        Studies advancing clinical trial readiness through development of biomarkers, clinical endpoints, and validation of pharmacokinetics/pharmacodynamics.

·        Pilot clinical trials, where limited clinical testing (e.g., small sample size) of a novel intervention to produce information on diagnostic or therapeutic effectiveness, safety, tolerability, or mechanisms of action. These studies should be aimed at obtaining preliminary data leading to the development of interventions with the potential to improve TSC outcomes.

·        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, include but are not limited to epilepsy surgery, tumor resection, reproductive health, perinatal surveillance and care, etc.

Preclinical studies may be appropriate but must include a clinical component. Projects that are strictly animal research will not be considered for CTRA funding and should consider other FY24 TSCRP funding opportunities.