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Congressionally Directed Medical Research Programs (CDMRP) -- Autism Research Program (ARP) -- Clinical Trial Award (CTA)
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. It is expected that the proposed clinical trial begin no later than 12 months after the award date, or 18 months after the award date for U.S. Food and Drug Administration (FDA)-regulated studies.
PIs seeking funding for a preclinical research project should consider the FY19 ARP Idea Development Award (Funding Opportunity Number: W81XWH-19-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 FY19 ARP Clinical Translational Research Award (Funding Opportunity Number: W81XWH-19-ARP-CTRA).
The proposed research must be relevant to active duty Service members, Veterans, military beneficiaries, and/or the American public.
• Pre-Application Deadline: May 1, 2019
• Invitation to Submit an Application: June 2019
• Application Submission Deadline: August 8, 2019
Areas of Interest
The FY19 ARP Clinical Trial Award seeks applications from all areas of clinical research, and strongly encourages applications that address the critical needs of the ASD community in one or more of the following areas: • Behavioral, cognitive, and other non-pharmacological therapies for ASD core symptoms or to alleviate co-occurring conditions • Pharmacological, genetic, and other biological treatments for ASD core symptoms or to alleviate co-occurring conditions • Dissemination/implementation of clinically validated interventions • Improve diagnosis and access to services across the life span • Interventions promoting success in key transitions to adulthood for individuals living with ASD • Healthcare provider-focused training or tools to improve healthcare delivery for individuals with ASD across the life span and the continuum of care (i.e., primary care, urgent/emergent care, and disaster relief) • Cultural, socioeconomic, and gender factors in diagnosis, treatment efficacy, delivery, and access to services
Investigators must be at or above the level of Associate Professor (or equivalent) to be named by the organization as the PI on the application.
For application submissions under the Partnering PI Option for Early Career Investigator:
• The Initiating PI (Mentor) named by the organization as the PI on the application must be at or above the level of Associate Professor (or equivalent).
• By the full application submission date, the Partnering PI (Early-Career Investigator) must: ○ Be in a current postdoctoral training position or have completed postdoctoral training. ○ Be no more than 7 years from the receipt of a terminal degree (excluding time spent in residency or on family medical leave). Lapses in research time or appointments as denoted in the biographical sketch may be articulated in the application.
• The Partnering PI (Early-Career Investigator) must demonstrate at least 50% of protected time for the proposed research that would be supported by this award.
• It is not required that the Partnering PI (Early-Career Investigator) and the Initiating PI (Mentor) be located at the same institution.
The anticipated direct costs budgeted for the entire period of performance for an FY19 ARP Clinical Trial Award will not exceed $1,000,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.
The anticipated direct costs budgeted for the entire period of performance for an FY19 ARP Clinical Trial Award with the Partnering PI Option for Early-Career Investigator will not exceed $1,155,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.