Modification of PAR-10-184: NIAID Clinical Trial Implementation Grant (R01)

Notice Number: NOT-AI-11-026

Release Date: January 3, 2011

National Institute of Allergy and Infectious Diseases (NIAID)

The purpose of this Notice is to announce a substantive change to requirements articulated in PAR-10-184: NIAID Clinical Trial Implementation Grant (R01).

In Section I, 1. Research Objectives, the "Scope" section of PAR-10-184:

Delete "include a randomized design" from the sentence that reads: "The trial must be hypothesis- driven, include a randomized design, and have clear primary and secondary endpoints."

Randomization is only required for those trials for which it is an appropriate element of trial design.

All other aspects of PAR-10-184 remain unchanged.

Please direct all inquiries to:

Anna Ramsey-Ewing, Ph.D.
Associate Director for Extramural Science Policy
Office of the Director
Division of Extramural Activities
National Institute of Allergy and Infectious Diseases
6700-B Rockledge Drive, MSC 7610
Bethesda, MD 20892-7610
Phone: (301) 435-8536
FAX: (301) 402-0369
E-mail: ar15o@nih.gov