Notice of Intent to Issue a PA on Investigator-Initiated Multi-Site Clinical Trials

Notice Number: NOT-HL-07-108

Key Dates
Release Date: March 12, 2007

Issued by
National Heart, Lung, and Blood Institute (NHLBI) (http://www.nhlbi.nih.gov/)

The purpose of this Notice is to announce the intention to issue in April 2007, a Program Announcement (PA) to support applications to develop investigator initiated Phase II-III multi-site randomized, controlled clinical trials. The trials may address any research question related to the mission of NHLBI and may involve clinical or behavioral interventions.

This future Funding Opportunity Announcement (FOA) will use the NIH Research Project Grant (R01) award mechanism. Some awards may be converted by NHLBI to cooperative agreements.

This Notice is to encourage investigators who believe that they have sufficient expertise to begin considering applying for this PA. Receipt dates will follow standard NIH receipt dates, with the first receipt date being June 5, 2007.

All applications for Phase II-III multi-center clinical trials involving a randomized clinical or behavioral intervention responding to this PA will undergo primary technical review by the Clinical Trials Review Committee (a standing review committee) or, more rarely, a similar ad hoc Special Emphasis Panel (SEP) managed by the NHLBI's Division of Extramural Research Activities.

This PA is not designed for single-center randomized trials, or multi-site studies without a randomized intervention. Investigators are referred to PA-07-070 Research Project Grant (Parent R01) at (http://grants.nih.gov/grants/guide/pa-files/PA-07-070.html) for such studies which will undergo primary technical review by the appropriate study sections in the Center for Scientific Review (CSR).

APPLICATIONS FOR THE PA ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Interested parties may contact:

Patricia Haggerty, Ph.D.
Section Chief
Review Branch
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
Two Rockledge Center, Suite 7194
6701 Rockledge Drive
Bethesda, MD 20892-7956 (Express 20817)
Phone (301) 435-0288
Fax (301) 480-3541
Email: haggertp@nhlbi.nih.gov