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Support for Clinical Trials at NIMH

Collage In 2014, NIH revised its definition of a clinical trial (see NOT-OD-15-015) and in 2016, launched a multi-faceted effort to enhance its stewardship over clinical trials (see NIH webpage on Clinical Trial Requirements for Grants and Contracts). All applicants conducting research on human subjects are encouraged to visit this webpage to better understand the definition of a clinical trial, new requirements for clinical trial research, and NIH strategies for implementation. Given the current NIH definition of clinical trials, some investigators may newly discover that their human subjects research is now a clinical trial and subject to the new NIH clinical trial requirements.

For due dates on or after January 25, 2018, NIH will require that all applications involving one or more independent clinical trials be submitted through a Funding Opportunity Announcement (FOA) specifically designated as ‘Clinical Trial Required’ or ‘Clinical Trial Optional’. The content below provides an overview of how the NIMH approaches its clinical trial portfolio and provides links to relevant NIMH FOAs that support clinical trial research. General inquiries regarding NIMH clinical trials and/or the clinical trial FOAs may be submitted to NIMHClinicalTrials@mail.nih.gov.

NIH Definition of a Clinical Trial

NIH defines a clinical trial as “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes” (NOT-OD-15-015). Go to NIH’s Definition of a Clinical Trial webpage to learn more and to find out if your study meets the NIH definition of a clinical trial.

NIMH FOAs to Address the Safety, Efficacy, and Effectiveness of Preventive, Therapeutic, and Services Interventions

NIMH solicits clinical trial applications through a series of FOAs that cover the intervention development pipeline, from first-in-human, early testing of new interventions, confirmatory efficacy trials, through to effectiveness trials. NIMH requires an experimental therapeutics approach (see Clinical Trials – Applicant FAQs, Q3) for the development and testing of therapeutic, preventive, and services interventions, in which the studies do not only evaluate the clinical effect of the intervention, but also generate information about the mechanisms underlying a disorder or an intervention response. Studies proposed under these FOAs must clearly identify a target or mediator of the intervention being tested. A positive result will require not only that an intervention improves clinical outcomes, but that it also has a demonstrable effect on a target, such as a neural pathway, a key cognitive operation, interpersonal or contextual factor that is hypothesized to mediate the intervention’s effect, etc.

The NIMH FOAs for therapeutic, preventive, and services interventions support a wide range of intervention modalities: cognitive, behavioral, and other psychosocial approaches, psychopharmacological interventions, and interventions utilizing direct brain modulation/stimulation. The choice of targets, measures, and clinical endpoints will vary with the intervention modality. Applicants should carefully read the FOA to which they are responding and the Clinical Trials — Applicant FAQs for more detail on the expectations for specific intervention modalities. Applicants are strongly encouraged to contact a Scientific/Research Contact listed at the end of the relevant FOA to discuss the FOA and NIMH priorities.

Clinical Trial Pipeline - Phase of Intervention Development*
General Inquiries: NIMHClinicalTrials@mail.nih.gov
First in Human Exploratory Experimental Therapeutics Confirmatory Efficacy Effectiveness (Prevention, Treatment, Services)

First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01 - Clinical Trial Required)*

 

Pilot Effectiveness Trials for Treatment, Preventive and Services Interventions (R34 - Clinical Trial Required)

 

Early Stage Testing of Pharmacologic or Device-based Interventions for the Treatment of Mental Disorders (R61/R33 - Clinical Trial Required) and (R33 - Clinical Trial Required)*

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

Development of Psychosocial Therapeutic and Preventive Interventions for Mental Disorders (R61/R33- Clinical Trial Required) and (R33 Clinical Trial Required)

Confirmatory Efficacy Clinical Trials of Non-Pharmacological Interventions for Mental Disorders (R01 Clinical Trial Required)

 

* The intent of the U01 and R61/R33 for drug development is to support early phase clinical trials to de-risk drug and device therapeutic candidates for further development.

Scientific/Research Contact Information
General Inquiries: NIMHClinicalTrials@mail.nih.gov
Application Due Dates: Standard Dates Apply

Scientific/Research Contact Information
General Inquiries:
NIMHClinicalTrials@mail.nih.gov
Application Due Dates: February 14, 2018; June 15, 2018; October 15, 2018 for all application types (new, resubmission, and revision applications).

Scientific/Research Contact Information
General Inquiries: NIMHClinicalTrials@mail.nih.gov
Application Due Dates: February 14, 2018; June 15, 2018; October 15, 2018 for all application types (new, resubmission, and revision applications).

Scientific/Research Contact Information
General Inquiries: NIMHClinicalTrials@mail.nih.gov
Application Due Dates: February 14, 2018; June 15, 2018; October 15, 2018 for all application types (new, resubmission, and revision applications).

Scientific/Research Contact Information
General Inquiries: NIMHClinicalTrials@mail.nih.gov
Application Due Dates: February 14, 2018; June 15, 2018; October 15, 2018 for all application types (new, resubmission, and revision applications).

Scientific/Research Contact Information
General Inquiries: NIMHClinicalTrials@mail.nih.gov
Application Due Dates: February 14, 2018; June 15, 2018; October 15, 2018 for all application types (new, resubmission, and revision applications).

Limited NIMH Participation on Parent Research Grant FOAs for Clinical Trials

NIMH utilizes the NIH Parent R01 and R21 Clinical Trial FOAs to accept “mechanistic” clinical trial applications only. A “mechanistic” clinical trial is designed to understand a biological or behavioral process; the pathophysiology of a disease; the mechanism of action of an intervention; or to advance biomarkers of physiological function, target engagement or impact of novel therapeutics. It does not have as a primary aim, establishing the efficacy or effectiveness of the intervention.

NIMH “mechanistic” clinical trials may fall into two categories (though there may be others):

  1. Mechanistic clinical trials using an intervention of known efficacy. These clinical trials utilize an efficacious intervention to investigate the pathophysiology, and/or psychopathology of mental disorders or the mechanisms of therapeutic responses; and to advance biomarkers of basic neurobiological processes. In such studies: (1) the primary aims do not involve establishing efficacy/effectiveness, and (2) the intervention chosen has already been demonstrated to have efficacy.
  2. Mechanistic clinical trials utilizing an experimental manipulation: These studies utilize an experimental manipulation and are primarily focused on understanding brain function by measuring responses to the experimental manipulation. These studies may not have been considered clinical trials in the past. See Case Study #18 on the NIH Definition of Clinical Trial Case Studies webpage.

NIH Guide Notice NOT-MH-18-004 describes they types of clinical trials that NIMH will support under these NIH FOAs.

Selected Other Clinical Trial FOAs

NIMH also participates on selected FOAs that seek or allow clinical trial application submission. Applications submitted to NIMH via these FOAs are expected to comport with NIMH’s experimental therapeutics model.

These FOAs include:

  • Announcements from other NIH Institutes or Centers (on which NIMH participates)
  • Career (K) FOAs that accept independent clinical trials (on which NIMH participates; see NIMH guidance for K applicants proposing Clinical Trials)
  • Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) FOAs

A current listing of these FOAs can be found on the NIMH Funding and Policy Announcements webpage.

Additional Resources for Applicants

Selected Publications

Published Guide Notices

  • NOT-MH-18-004 (November 3, 2017) - NIMH Only Accepts Clinical Trial Applications Proposing Mechanistic Studies for Clinical Trial Parent R01 and R21 Announcements
  • NOT-MH-17-044 (August 17, 2017) - Notice of NIMH's Interest in Pediatric Pharmacologic Trials in Autism Spectrum Disorders, directed at testing selective GABAergic agents
  • NOT-MH-17-039 (July 24, 2017) - Notice of NIMH's Interest to Highlight High-Priority Pediatric Pharmacologic Trial Research Areas
  • NOT-MH-15-012 (March 17, 2015) - Data Sharing Expectations for Clinical Research Funded by NIMH
  • NOT-MH-15-009 (January 16, 2015) - Notice Announcing Data Harmonization for NIMH Human Subjects Research via the PhenX Toolkit
  • NOT-MH-14-015 (June 12, 2014) - Data Sharing Expectations for NIMH-funded Clinical Trials
  • NOT-MH-14-004 (January 15, 2014) - Enhancing the Reliability of NIMH-Supported Research through Rigorous Study Design and Reporting

Clinical Trials — Applicant FAQs

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