Planning Grants for Clinical Trials (R34)

NIGMS now offers the R34 planning grant mechanism. Support can be requested to assemble all necessary information prior to making an R01 application to NIH requesting support for the full trial. Foreign institutions are not eligible for this mechanism. See NIH Guide notice GM-13-126 for more information on the NIGMS policy for the acceptance of clinical trial applications.

Features of an R34 planning grant application:

  • Enables peer review of scientific rationale
  • Time for finalization of design/protocol
  • Planning and development of documentation, including manual of operations, informed consent, training materials, etc.
  • Establishment of safety and oversight plans, including a charter if a DSMB is expected
  • Time for submission(s) for IRB approvals
  • Planning for data handling, statistical analysis
  • Identification of coordinating center
  • Time to seek recruitment sites
  • Development of complete trial budget
  • Acquisition of the study agent(s)
  • Up to $100,000 direct costs
  • Duration of up to 1 year​