DoD Autism Research Program, Clinical Trial Award

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The ARP Clinical Trial Award supports research with the potential to have a major impact on the treatment or management of ASD. Funding from this award mechanism must support a clinical trial and may not be used for preclinical research studies. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention, or other) is tested on a human subject for a measurable outcome with respect to safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. Principal Investigators (PIs) seeking funding for a preclinical research project should consider the FY17 ARP Idea Development Award (Funding Opportunity Number: W81XWH-17-ARP-IDA). Further, PIs seeking funding for the initial development and proof-of-principle testing of an intervention, and not a robust statistically powered clinical trial, should consider the FY17 ARP Clinical Translational Research Award (Funding Opportunity Number: W81XWH-17-ARP-CTRA). The term “human subjects” is used in this Program Announcement to refer to individuals who will be recruited for or who will participate in the proposed clinical trial. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm.

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