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 (with or without NIH funding regardless of whether a planning grant application has been funded) 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.

NIGMS now offers a planning grant mechanism for clinical trials, per discussion and concept approval at the September 2010 National Advisory General Medical Sciences Council meeting, and details can be found in PAR-17-268. Funding will enable limited time and support to assemble all necessary documentation prior to making an R01 application to NIH requesting full support for a clinical trial. Additionally, this will allow early review of the scientific rationale for the proposed clinical trial.

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

Planning Grants for Clinical Trials (R34)

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