Notice of Change to NIDCD Phase I/II/III Clinical Trials in Communication Disorders

Notice Number: NOT-DC-12-004

Update: The following update relating to this announcement has been issued:

Key Dates
Release Date: November 18, 2011

Issued by
National Institute on Deafness and Other Communication Disorders (NIDCD)


The NIDCD clinical trials program is changing from soliciting applications with the R01 Research Program Grant mechanism to the U01 Cooperative Agreement mechanism.  NIDCD has routinely utilized the U01 mechanism to facilitate the management of phase III clinical trial awards in recent years with positive benefits for both NIDCD and clinical trial PIs.  NIDCD’s new approach will extend the U01 benefits into the application stage and will now include all phases of clinical trials.  A U01 cooperative agreement enables the NIDCD program official to have substantial involvement as Project Collaborator in helping with trial design before award and execution after award, in addition to normal stewardship.  The proposed Funding Opportunity Announcement (FOA) will support a cooperative agreement between NIDCD project collaborator and investigator to support phase I and II clinical trials of preliminary efficacy and phase III clinical trials of definitive efficacy. 

This change is projected to take effect in the spring 2012 with the anticipated first receipt date in June 2012, and will replace both PAR-08-205 NIDCD Phase III Definitive Clinical Trials in Communication Disorders (R01), and PAR-11-290 NIDCD Phase I/II Preliminary Clinical Trials in Communication Disorders (R01).  NIDCD anticipates that PAR-08-205 and PAR-11-290 will remain active until after their Cycle I receipt dates.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and projects.


Please direct all inquiries to:

Gordon B. Hughes, M.D.
Division of Scientific Programs
National Institute on Deafness and Other Communication Disorders
6120 Executive Blvd.
EPS-400C MSC 7180
Bethesda, MD 20892-7180
Telephone: 301-435-4085
Fax: 301-402-6251

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