NIGMS Clinical Trials

Research Projects: Research Project (R01), Investigator-Focused Award (R35), and Research Project with Complex Structure (RM1)

NIGMS only funds investigator-initiated clinical trial applications using the R01, R35, and RM1 mechanisms that are within the NIGMS clinical research areas:

• anesthesiology,
• clinical pharmacology, 
• injury and critical illness, 
• sepsis, and
• wound healing.

Limitations

For R01s, R35, and RM1s, NIGMS generally does not support:

• Exploratory or pilot/feasibility clinical trials unless arrangements for support of the large-scale clinical trial have been negotiated.
• Trials to evaluate clinical outcomes such as safety, tolerability, clinical efficacy, or effectiveness.
• Large-scale, multi-site clinical trials to optimize trial efficiency, recruitment, and oversight.
• Trials that are specifically designed to seek regulatory approval of future clinical diagnostics or treatments.
• Clinical dissemination and implementation research, comparative effectiveness or outcomes research, and/or pragmatic clinical trials.

Small Business Awards

NIGMS prioritizes small business award clinical trials that promote research in NIGMS clinical research areas:

• anesthesiology,
• clinical pharmacology, 
• injury and critical illness, 
• sepsis, and
• wound healing.

NIGMS has a particular interest in:

• Small business clinical trials applications that focus on the development of technologies to address complex and interdisciplinary research questions in clinical areas that impact multiple organs systems.

Limitations

For small business awards, NIGMS generally does not support:

• Large-scale, multi-site clinical trials to optimize trial efficiency, recruitment, and oversight
• Clinical dissemination and implementation research, comparative effectiveness or outcomes research, and/or pragmatic clinical trials.

Career Development Awards

NIGMS does not prioritize the use of mentored career awards for candidates to serve as the lead investigator of an independent clinical trial, a clinical trial feasibility study, or a separate ancillary study to an existing trial.

NIGMS encourages candidates to work with mentors who have funding for ongoing clinical trials to develop the skills needed for future independent clinical trial research relevant to NIGMS clinical areas: 

• anesthesiology 
• clinical pharmacology
• injury and critical illness
• sepsis

Research Capacity Building Programs

NIGMS supports research capacity building clinical trials through:

• The Institutional Development Award (IDeA) program
• Native American Research Centers for Health (NARCH) program

NIGMS supports clinical trials supported through the IDeA and NARCH programs in research areas that are within the mission of the NIH.