NIDCD Phase III Definitive Clinical Trials in Communication Disorders (R01)

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-Purpose. This funding opportunity announcement (FOA) is targeted toward supporting well-designed, investigator-initiated Phase III Definitive Clinical Trials (DCT) to establish safe and effective treatments or interventions for communication disorders. A Phase III DCT proposed under this FOA should have the potential to provide a significant impact on clinical practice or public health policy if successful. It is expected that applicants for a Phase III DCT already have adequate pre-clinical and preliminary clinical data to support the Phase III DCT. Also, information necessary to address core design and clinical issues prior to the conduct of the Phase III DCT should have already been established, and a complete, detailed Manual of Procedures (MOP) has been developed. The MOP MUST be submitted as an appendix to the Phase III Definitive Clinical Trial application. The NIDCD Clinical Trial Planning Grant (R34) (PAR-08-203) and/or the NIDCD Phase I/II Preliminary Clinical Trial FOA (PAR-08-204) can be used to gather this information and prepare the MOP. -Mechanism of Support. This FOA will utilize the NIH Research Project Grant (R01) award mechanism. Awards for multicenter Phase III DCTs or awards of $500,000 or more in direct costs in any grant year will be converted to the cooperative grant award mechanism (U01).-Funds Available and Anticipated Number of Awards. Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

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