View item

US National Institutes of Health – Clinical Trials to Test the Effectiveness of Treatment, Preventive, and Services Interventions (Collaborative R01 - Clinical Trial Required) – RFA-MH-18-700
Sponsor: US National Institutes of Health 		Closing Date: 15-Oct-2018
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)."

Examples of studies that are not responsive to this FOA and will not be reviewed include the following:
• Applications whose scope of work involves examining intervention effectiveness without studying whether the intervention engages the target(s) presumed to underlie benefits and without examining whether intervention-induced changes in targets are associated with clinical benefit.
• Adaptations of existing interventions in the absence of a compelling justification and in the absence of a clear experimental therapeutics approach to examining how the intervention engages the adaptation target (see the NAMHC Workgroup Report, “From Discovery to Cure: Accelerating the Development of New and Personalized Interventions for Mental Illnesses http://www.nimh.nih.gov/about/advisory-boards-and-groups/namhc/reports/fromdiscoverytocure.pdf”, see Recommendation 2.4.1, page 19, for additional guidance regarding the empirical justification for intervention adaptations and augmentations.)
• Studies conducted in academic research laboratories as opposed to effectiveness studies in community practice clinics/settings (e.g., studies in research clinics that involve research therapists or other features that are not representative of typical practice settings and substantially impact generalizability).
• Trials using patented medications that lack superior efficacy or safety relative to currently available off-patent medications.
• Studies of stigma or health literacy interventions that do not explicitly study the impact on mental health service access, engagement, quality and/or outcomes of care.

Eligibility
• Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
• Applications from Foreign Organizations: Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Funding
• Application budgets are not limited but need to reflect the actual needs of the proposed project
• The maximum project period is 5 years; however, applicants are strongly encouraged to propose a project period of 3 or 4 years.

Please see the Funding Opportunity Announcement for further information. Applications may be prepared and submitted via the NIH ASSIST system or Grants.gov. For complete instructions, you must refer to both the NIH Application Guide and the Funding Opportunity Announcement (FOA), noting that instructions in the FOA take precedence over the Application Guide.

Key Dates
Letter of Intent (non-mandatory) due to NIH: 15 September 2018
Applications due to UQR&I: 1 October 2018
Applications close with NIH: 15 October 2018, 5:00pm local time of applicant organisation
Future application closing dates: 15 February 2019, 15 June 2019, 15 October 2019, 14 February 2020, 15 June 2020, 15 October 2020
Expiration date of FOA: 16 October 2020 (new date; original expiration date: 16 October 2018)

Ahead of internal review, ensure all online components on ASSIST or Grants.gov are complete. To initiate review, email your completed Funding Application Coversheet to internationalgrants@research.uq.edu.au. Interested applicants are strongly encouraged to make contact with the UQR&I international team (via internationalgrants@research.uq.edu.au) well in advance of the UQR&I internal deadline to discuss their application.
Website: https://grants.nih.gov/grants/guide/rfa-files/RFA-MH-18-700.html

Return