Advancing Real-World Effectiveness Evidence for Rapid-Acting Psychotropic Interventional Drugs (RAPIDs) (UM1 Clinical Trial Required)

The National Institutes of Health is seeking applications to establish the Rapid-Acting Psychotropic Interventional Drugs Clinical Trials Network (RAPIDs-CTN) under solicitation RFA-MH-27-150. The program aims to generate real-world evidence on the safe and effective implementation of rapid-acting psychotropic drugs in routine clinical practice, specifically for high-need populations such as those with treatment-resistant conditions or acute suicide risk. The project utilizes a milestone-driven UM1 Cooperative Agreement mechanism with a total program funding of 12 million dollars and an expected three awards. The network will be structured around a centralized Data Coordinating Center (DCC) and Federated Clinical Sites (FCS) located in diverse settings, including community mental health centers, VA medical centers, and emergency departments. The project is divided into two operational stages: Stage 1 (Years 1–2) focuses on network establishment, site onboarding, and pilot studies to determine safety, feasibility, and costs. Stage 2 (Years 3–5) involves the full-scale execution of unified pragmatic trials. Key requirements include the use of NIMH-supported Common Data Elements for data harmonization and the establishment of automated pipelines for data deposition into the NIMH Data Archive. Applicants must provide letters of collaboration for clinical site commitments and adhere to strict cybersecurity guidelines. Evaluation is based on scientific merit, study design, ethical considerations, and the ability of the DCC to manage multi-site governance and safety monitoring. Applications must be submitted by June 10, 2027, and require active SAM and eRA Commons registrations.