DoD Tuberous Sclerosis Complex Pilot Clinical Trial Award
The PCTA mechanism supports exploratory studies involving limited human exposure that produce diagnostic or therapeutic information, safety, and tolerability studies and studies to determine the mechanism of action. These studies should be aimed at obtaining preliminary data leading to the development of interventions, as well as clinical biomarkers, with the potential to improve TSC outcomes. Preclinical studies will not be supported by this mechanism. Examples of acceptable studies include but are not limited to the following: â₏¢ Identification of an appropriate population for the proposed study. â₏¢ Identification of the dosage, duration, and/or delivery strategy of an intervention. â₏¢ Evaluation of the feasibility of the intervention in TSC. â₏¢ Development of clinical biomarkers or outcome measures for future clinical trials. â₏¢ Evaluation of efficacy and safety. If the clinical trial involves the use of a drug that has not been approved by the U.S. Food and Drug Administration (FDA) for the proposed investigational use, then an Investigational New Drug (IND) application to the FDA that meets all requirements under the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312) must be submitted to the FDA prior to the application submission deadline. If the investigational product is a device, evidence that an Investigational Device Exemption (IDE) application that meets all requirements under 21 CFR 812 has been submitted to the FDA prior to the application submission deadline, or that the device is exempt from an IDE, is required. Documentation of approval or exemption of the IND or IDE prior to programmatic review must be obtained and submitted to the CDMRP Help Desk (help@eBRAP.org), otherwise the Government reserves the right to withdraw the application
Office: U.S. Army Medical Research Acquisition Activity
Phone: 301-682-5507
