The 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 ASD. Applications are strongly encouraged to address one of the FY24 ARP Clinical Trial Award Areas of Interest. 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.
Research funded by the FY24 ARP should be responsive to the needs of people with ASD, their families, and/or caregivers. Researchers are therefore encouraged to establish and utilize effective collaborations and partnerships with community members to maximize the impact potential of the proposed research.
CDMRP encourages research on health areas and conditions that affect women uniquely, disproportionately, or differently from men, including studies analyzing sex as a biological variable. Such research should relate anticipated project findings to improvements in women’s health outcomes and/or advancing knowledge for women’s health.
Deadlines:
• Required Pre-Application Deadline: May 16, 2024
• Invitation to Submit an Application: June 2024
• Application Submission Deadline: Aug. 15, 2024
To meet the intent of the funding opportunity the ARP encourages applications that address critical needs of the ASD community in one or more of the FY24 ARP Clinical Trial Award Areas of Interest.
• (New for FY24) Community supported and participatory research interventions
• Cultural, socioeconomic, and gender factors in diagnosis, treatment efficacy, delivery, and access to services
• Pharmacological, genetic, and other biological treatments for ASD core symptoms or to alleviate co-occurring conditions
• Dissemination/implementation of clinically validated interventions
• (New for FY24) Gender identity and sexual health, including puberty and sexual education for Autistic individuals
• Health care provider-focused training or tools to improve health care delivery for Autistic individuals across the life span and the continuum of care (i.e., primary care, urgent/emergent care, and disaster relief)
• Improve diagnosis and access to services across the life span
• Interventions promoting success in key transitions to adulthood for individuals living with ASD
• Mental health issues (such as grief, masking, suicide risk, trauma, etc.) or disorders in Autistic individuals
• Non-pharmacological therapies for ASD core symptoms or to alleviate co-occurring conditions (including pain, sleeping, eating)
• Pragmatic trials
• (New for FY24) Uncovering new advances using a strength-based model
• Understanding heterogeneity in treatment response, including identification of psychosocial or biological factors that (1) impact treatment outcomes or (2) can be used to prospectively identify treatments that are most likely to benefit particular subgroups of individuals
• Understanding physical health and related issues in aging Autistic adults, including cardiovascular issues, joint pain, asthma, obesity, etc.
For application submissions under the Single PI Option: Investigators must be at or above the level of Assistant 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 Assistant 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 contribute at least 50% effort 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 FY24 ARP CTA should not exceed $1.9M. 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 FY24 ARP CTA with the Partnering PI Option for Early-Career Investigator will not exceed $2.2M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.