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In 2016, NIH launched a multi-faceted effort to enhance its stewardship over clinical trials. This effort, commonly known as the
NIH Clinical Trial Stewardship Reforms, was undertaken with the overall goals of ensuring rigor, transparency, and effectiveness of NIH-funded clinical trials.
NIH definition of a clinical trial was revised in 2014 in anticipation of these stewardship reforms to ensure a clear and responsive definition of a clinical trial. The
NIH definition of a clinical trial applies to a wide range of clinical trials (mechanistic, exploratory/development, pilot/feasibility, interventional, behavioral). Many clinical studies that were not considered to be clinical trials under the pre-2014 classification scheme now fall under the revised
NIH definition of a clinical trial. Resources (case studies,
FAQs, and a
decision tool) are available to help applicants determine if their clinical study is considered to be a
NIH-defined clinical trial.
Since January 25, 2018,
NIH policy has required all applications involving one or more clinical trials to be submitted through a Notice of Funding Opportunity (NOFO) specifically designed for clinical trials. A list of clinical trial required and clinical trial optional FOAs in which NIGMS participates can be found
here by selecting Clinical Trial in the Type of Research box.
Investigators are strongly encouraged to become familiar with
NIH Requirements for Clinical Trials and to consult with
NIGMS Clinical Trials Staff Contacts early in the planning process of their clinical trial application. Note that many
NIGMS clinical trial FOAs have restrictions on the types of clinical trials that are permitted. For example, clinical trials that are designed to test safety and efficacy of interventions (Phase I, Phase II, Phase III) for the purpose of future clinical treatment and/or regulatory approval are not permitted in the
NIGMS MIRA and
Multidisciplinary Teams/Collaborative Research Programs. Consultation with
NIGMS Clinical Trials Staff Contacts as well as the Scientific/Research Contacts on the FOA of interest at least 10 weeks prior to the application due date is strongly encouraged.
Clinical Trials Staff Contacts
Clinical Research Subject Areas
Investigator-Initiated Applications for Clinical Trials (R01)
NIGMS Guidelines for Data and Safety Monitoring in Clinical Trials
Clinical Studies and Trials Resources
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