Single Source: Accelerating Medicines Partnership Schizophrenia (AMP SCZ): Clinical Trial Data Processing, Analysis, and Coordination Center (U24 Clinical Trial Not Allowed) | RFA MH 24 151

Opportunity Information: Apply for RFA MH 24 151

This NIH funding opportunity (RFA-MH-24-151) supports a single-source cooperative agreement (U24) to stand up and run the Clinical High Risk for Psychosis Clinical Trial Data Processing, Analysis, and Coordination Center, or CTDPACC. The core purpose of the award is not to run the clinical trial sites themselves, but to provide the centralized “backbone” that makes a multi-site proof-of-principle study work smoothly: executive management, operational direction, overall coordination, and the full set of data processing and analysis functions needed to support the companion funding opportunity that establishes the Clinical High Risk (CHR) for Psychosis Clinical Trial Network. The trial context is a 12 to 16 week proof-of-principle (PoP) study that will use one or more “Phase 2 ready” compounds, meaning interventions sufficiently mature for mid-stage clinical testing rather than early exploratory agents.

Programmatically, the opportunity sits within the Accelerating Medicines Partnership Schizophrenia (AMP SCZ) effort, which previously evaluated drug development tools such as biomarkers, predictive or stratification algorithms, and clinical outcome measures. The CHR for Psychosis Clinical Trial Network is intended to validate how useful those tools really are in a prospective clinical trial environment, especially in people at clinical high risk for psychosis. The CTDPACC is therefore positioned as the integrator and analytic hub: it aligns the network on common procedures, ensures consistent and high-quality data flow, and delivers the statistical and informatics capabilities needed to test whether the AMP SCZ-derived tools can reliably support decision-making in treatment development.

Operationally, “data processing, analysis, and coordination” implies responsibility for creating and enforcing data standards across sites, building or managing the study database and data pipelines, monitoring data quality and completeness, and supporting timely interim and final analyses. It also implies a leadership role in trial logistics that typically includes harmonizing protocols and manuals of procedures, coordinating communications and reporting, supporting governance and decision-making structures, and helping the network stay on schedule during a relatively short PoP window. Because this is a cooperative agreement, NIH program staff generally have substantial involvement compared with a standard grant, so the funded center is expected to work closely with NIH and the companion trial network to execute the workplan and meet shared milestones.

The opportunity is listed under NIH, with the activity category in health and the CFDA number 93.242. The eligible applicant type called out in the provided source data is public and state-controlled institutions of higher education. The eligibility language also makes clear that non-U.S. (foreign) institutions cannot apply, and non-U.S. components of U.S. organizations are also not eligible to apply; however, “foreign components” as defined by the NIH Grants Policy Statement are allowed, which typically refers to discrete project elements performed outside the U.S. under a U.S. applicant organization, subject to NIH rules and justification. Applicants would need to rely on the full Notice of Funding Opportunity text for the precise definitions, documentation expectations, and any additional eligibility constraints.

Key administrative details included in the listing are that the sponsor is the National Institutes of Health, the funding instrument is a cooperative agreement (U24), and the original closing date was October 17, 2023, with a creation date of July 12, 2023. The title also states “Clinical Trial Not Allowed,” which in NIH terminology usually means the U24 itself should not propose to conduct an independent clinical trial as the primary funded activity; instead, it supports the clinical trial network and its study through coordination and analytic infrastructure functions rather than serving as a separate clinical trial award.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Single Source: Accelerating Medicines Partnership Schizophrenia (AMP SCZ): Clinical Trial Data Processing, Analysis, and Coordination Center (U24 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242.
• This funding opportunity was created on 2023-07-12.
• Applicants must submit their applications by 2023-10-17. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Public and State controlled institutions of higher education.

Apply for RFA MH 24 151

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