Cancer Prevention and Control Clinical Trials Planning Grant Program (R34 Clinical Trials Optional)

The FOA will support studies for the acquisition of data critical to complete the protocol of a full-scale multi-center Phase II or later phase trial. Applicants must describe the proposed future clinical trial and identify the specific issues that require additional planning. Although the scientific literature or preliminary data may provide the rationale for conducting a future clinical trial, investigators often lack critical information about the study population, intervention, outcome, or operational risks necessary to finalize the trial protocol completely. The immediate goal is that the proposed studies will yield information that is both scientifically necessary and also sufficient to permit final decisions about the design or conduct of the clinical trial that increase rigor and feasibility. Preliminary studies may be needed to fill information gaps and address unknowns this can include a pilot/ feasibility clinical trial if necessary, thereby improving trial design and rigor.