NIGMS supports a limited number of investigator-initiated clinical trials in selected areas related to its mission, including trauma, burn and peri-operative injury; wound healing; sepsis; and anesthesiology and peri-operative pain. We will now offer planning grants (see PAR-11-287) to enable the assembly of the organizational elements and documentation needed for a clinical trial R01 application. This will also permit early peer review of the scientific rationale of a proposed trial. Before applying for a planning grant, we strongly recommend consulting with the appropriate NIGMS program staff listed in the funding opportunity announcement to determine whether the goal of the proposed trial aligns with the NIGMS mission and scientific priorities. Letters of intent for the planning grants are due by September 24, 2011, and applications are due by October 24, 2011. We will accept subsequent submissions on the same dates in 2012 and 2013. As this planning grant program proceeds, we will assess its value to applicants, and we welcome your feedback at any time. For more information, please see the NIGMS Web site on Clinical Studies and Trials.