Clinical Studies and Trials

The Pharmacological and Physiological Sciences Branch in the NIGMS Division of Pharmacology, Physiology, and Biological Chemistry accepts investigator-initiated R01 applications for clinical studies and trials directly related to the Institute's research areas, subject to the following requirements.

Investigators are strongly encouraged to consult with NIGMS staff at the earliest stages to establish the appropriateness of their proposal and to review Institute requirements. Staff will determine whether the goal of a trial fits the Institute's scientific mission and if in staff's judgment NIGMS would want to support the full trial if properly planned. The planning process must be complete before NIGMS will accept a multisite trial application that exceeds $500,000 in direct costs in any year. See NIH Guide notice GM-14-130 for more information on the NIGMS policy for the acceptance of clinical trial applications.

The review of NIGMS clinical trial applications will vary according to the cost and scope of the study. Applications for single-site studies under $500,000 in direct costs per year generally will be reviewed within the standing study sections of the NIH Center for Scientific Review. Applications for multisite studies generally will be reviewed within the NIGMS Office of Scientific Review. All multisite trial applications and/or applications that exceed $500,000 in direct costs in any year are subject to Institute budget policies and NIH presubmission requirements.

Clinical Studies and Trials Staff Contacts

Information Required to Discuss Clinical Trial Applications

Investigator-Initiated Applications for Clinical Trials (R01)

NIGMS Guidelines for Data and Safety Monitoring in Clinical Trials

Criteria for Assessing Clinical Trial Applications at NIGMS

Clinical Studies and Trials Resources