NIDCD Phase I/II Preliminary Clinical Trials in Communication Disorders (R01)

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-Purpose. The NIDCD is committed to identifying effective interventions for the treatment or prevention of communication disorders by supporting robust, well-designed, and well-executed clinical trials. Before a full scale Phase III Definitive Clinical Trial (DCT) (PAR-08-205) can be undertaken, earlier stage Phase I/II Preliminary Clinical Trials (PCT) are often required. This FOA is specifically targeted towards supporting studies that will provide the preliminary data that are necessary to address core scientific, design, and clinical issues prior to the conduct of the Phase III DCT. It is intended that these PCTs will serve to optimize the design of the eventual Phase III DCT and NOT address the definitive clinical question with lower power. -Mechanism of Support. This FOA will utilize the NIH Research Project Grant (R01) grant mechanism. Applications involving multi-sites or with $500,000 or more in Direct Costs in any grant year may be converted to the U01 grant mechanism (cooperative agreement) at the time of the award indicating substantial NIDCD staff involvement. -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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