OpportunityTitle: NIDCD Phase I/II Preliminary Clinical Trials in Communication Disorders (R01)
AdditionalInformationOnEligibility: Other Eligible Applicants include the following:   Alaska Native and Native Hawaiian Serving Institutions; Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.  Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.    Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Description: 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.
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GrantorContactText: NIH OER Webmaster &lt;br/&gt;FBOWebmaster@OD.NIH.GOV &lt;br/&gt;