Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (Collaborative R01-Clinical Trial Required)

Funder: National Institutes of Health

Due Date: 10/15/2018

Budget: $18,000,000

Opportunity: RFA-MH-18-700

This Funding Opportunity Announcement (FOA) seeks to support clinical trials to establish the effectiveness of interventions and to test hypotheses regarding moderators, mediators, and mechanisms of action of these interventions. This FOA supports clinical trials designed to test the therapeutic value of treatment and preventive interventions for which there is already evidence of efficacy, for use in community and practice settings. Applications might include research to evaluate the effectiveness or increase the clinical impact of pharmacologic, somatic, psychosocial (psychotherapeutic, behavioral), device-based, rehabilitative and combination interventions to prevent or treat mental illness. This FOA also supports clinical trials to test patient-, provider-, organizational-, or systems-level services interventions to improve access, continuity, quality, equity, and/or value of services. The intervention research covered under this announcement is explicitly focused on practice-relevant questions.

This FOA supports trials that require participation of two or more collaborative sites for completion of the study. Accordingly, the collaborating studies share a specific protocol across the sites and are organized as such in order to increase sample size, accelerate recruitment, or increase sample diversity and representation. Each site has its own Program Director/Principal Investigator (PD/PI) and the program provides a mechanism for cross-site coordination, quality control, database management, statistical analysis, and reporting.  Support for fully-powered effectiveness studies via a single R01 grant is provided through a separate FOA, RFA-MH-18-701 “Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Applications (R01).”

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