Summary: The fiscal year 2026 (FY26) Autism Research Program (ARP) Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of autism. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept trials (e.g., pilot, first-in-human, phase 0) to demonstrate the feasibility or inform the design of more advanced trials through large-scale trials to determine efficacy in relevant patient populations.

Distinctive Features:

Applications are strongly encouraged to address one of the FY26 ARP Clinical Trial Award Areas of Interest.

Partnering Principal Investigator (PI) Option for Early-Career Investigator: The FY26 Clinical Trial Award mechanism is offering a higher level of funding for applications that propose to partner an experienced PI (i.e., Initiating PI) with an Early-Career Investigator (i.e., Partnering PI) wishing to pursue a career in autism clinical trial research.

FY26 Clinical Trial Award submissions are required to include community collaborations to optimize research impact. Research teams are therefore required to establish and utilize effective and equitable collaborations and partnerships with community members to maximize the translational and impact potential of the proposed research. Applications to the FY26 ARP Clinical Trial Award are expected to name at least one community partner (e.g., Autistic individual or caregiver, representatives of community-based organizations) who will provide advice and consultation throughout the planning and implementation of the research project. Interactions with other team members should be well integrated and ongoing, not limited to attending seminars and semi-annual meetings (see Attachment 12, Community Collaboration Plan).

Miscellaneous

• Unrestricted