NIDCD Definitive Phase III Clinical Trial Planning Grant (R34)

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Purpose. The goal of this FOA is to provide support to complete the development of a comprehensive research protocol for large-scale, multicenter Phase III Definitive Clinical Trials (DCT). The planning grant is designed to permit early peer review of the proposed clinical trial in terms of its rationale, general design, organizational structure and implementation plan. The planning grant is used to support the development of a detailed Manual of Procedures (MOP) which is required for submission when applying for a Phase III Definitive Clinical Trial (PAR-08-205). The planning grant will provide support to establish the research team, develop tools for data management and oversight of the research, define recruitment strategies, and develop and finalize the MOP. The Planning Grant is NOT intended to support small Phase I/II Preliminary Clinical Trials. Applications for Phase I/II Preliminary Clinical Trials should use the NIDCD Phase I/II Preliminary Clinical Trials in Communication Disorders (PAR-08-204). Mechanism of Support. This FOA will utilize the R34 funding mechanism. Funds Available and Anticipated Number of Awards. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.

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