NIGMS accepts investigator-initiated applications for clinical trials using the R01 mechanism with the following considerations and limitations (see NOT-GM-22-027 for further details).

Considerations

• The proposed clinical trial must be completely within the NIGMS clinical research areas (anesthesiology, clinical pharmacology, injury and critical illness, sepsis, wound healing) supported by the Division of Pharmacology, Physiology and Biological Chemistry (PPBC).
• The primary objective of the trial should be to provide mechanistic understanding of the biology underlying one or more of the NIGMS PPBC Division clinical research areas.
• A strong evidence base of fundamental biological and clinical information supporting a robust, mechanistic hypothesis for the trial should already exist in peer-reviewed literature.

Limitations

• NIGMS typically does not support exploratory or pilot/feasibility clinical trials unless arrangements for support of the large-scale clinical trial have been negotiated.
• NIGMS is unlikely to support large-scale or multi-site clinical trials unless other NIH institutes/centers or federal agencies agree in advance to establish partnerships to optimize trial efficiency, recruitment, and oversight.
• NIGMS generally will not support trials that are specifically designed to seek regulatory approval of future clinical diagnostics or treatments.
• NIGMS does not support clinical dissemination and implementation research, comparative effectiveness or outcomes research, and/or pragmatic clinical trials.

Clinical studies that do not meet the Revised NIH Definition of “Clinical Trial” should be submitted via the PA 20-185 NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed) notice of funding opportunity. NIGMS encourages discovery research in the NIGMS clinical research areas – for example, an observational study intended to provide biospecimens for molecular analyses that provide mechanistic understanding that will inform future clinical research/trials. We strongly encourage advance discussion with NIGMS staff of all applications that involve clinical studies or clinical trials. All clinical study and clinical trial applications above $500,000 direct costs in any one year are subject to NIH pre-submission requirements.

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