The purpose of the NIH Clinical Trial Planning Grant (R34) is to provide support for the development of a Phase III clinical trial, including the establishment of the research team, the development of tools for data management and oversight of the research, the definition of recruitment strategies, and the finalization of the protocol and other essential elements of the study included in a manual of operations/procedures. The Clinical Trial Planning Grant is not designed for the collection of preliminary data or the conduct of pilot studies to support the rationale for a clinical trial.
An NIH-defined Phase III clinical trial is a broadly based prospective clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or control intervention or comparing two or more existing treatments. Often, the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions for disease prevention, prophylaxis, diagnosis or therapy. Community- and other population-based intervention trials also are included.
The planning grant is designed to permit early peer review of the rationale and design of the proposed clinical trial and to provide support for the development of a detailed Manual of Procedures (MOP) including all elements essential to the launching of a trial.
Investigators wishing to apply for an R34 grant should be aware that individual ICs may have specific requirements for this funding mechanism and, therefore, should consult IC staff to determine if an application is appropriate. NIH Offices that participate in this PA (ORWH, OBSSR, ORD, ODS) are listed but do not have funding authority and must work through an Institute or Center.