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

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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 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.Preclinical studies may be appropriate but must include a clinical component.

Projects that are strictly animal research will not be considered for funding and should consider other FY23 TSCRP funding opportunities.