NINDS Clinical Trial Planning Grant (R34)

The NINDS seeks to fund high quality clinical trials to evaluate treatments for neurological disorders. This Funding Opportunity Announcement (FOA) invites applications under the NINDS Clinical Trial Planning Grant Program, the purpose of which is to provide support for the organization of activities critical for the successful implementation of high-risk, complex, or large-scale clinical trials. The planning grant is intended to (a) allow for early peer review for the rationale and design of the proposed clinical trial; (b) provide support for the development of a detailed manual of operations and procedures; and (c) provide support to develop essential elements of a clinical trial, such as the development of tools for data management and oversight of the research, the definition of recruitment strategies, the finalization of the protocol, analytical techniques, facilities, administrative procedures, obtaining IND/IDE, and the establishment of collaborative arrangements. The purpose of the NINDS planning grant is not to obtain preliminary data or to conduct pilot studies to support the rationale or the clinical trial. The expected product of the planning grant is a detailed clinical trial research plan including a complete manual of operations and procedures. Included in the planning grant application must be a completed study protocol and projected direct costs for the future phase III trial.