Notice of the NHLBI Program for Ancillary Studies in Clinical Trials

Notice Number: NOT-HL-06-136

Key Dates
Release Date: October 31, 2006

Issued by
National Heart, Lung, and Blood Institute (NHLBI), (

The purpose of this Notice is to announce the intention to issue a Request for Applications (RFA) in late 2006 to solicit research grant applications to conduct time-sensitive ancillary studies in conjunction with ongoing Phase II-III clinical trials or network clinical trials related to heart, lung, and blood diseases and sleep disorders.   The first receipt date for applications would be early 2007.

This RFA will provide a flexible mechanism to capitalize on the current investment in clinical trials, by using their patient cohorts, data, and biological materials. Using the R01 mechanism structure, the ancillary study can address any research question related to the mission of NHLBI for which the parent study can provide participants and infrastructure.   However, parent trials do not have to be related to the NHLBI mission.  All ancillary study applications must demonstrate the time-sensitive nature of their proposal.  Also, all parent trials must be independently funded and will not receive support under this RFA. 

This initiative will use an accelerated review/award process in place of the procedures traditionally used for investigator-initiated research grants to allow applicants to plan and conduct their time-sensitive ancillary studies in coordination with the work schedules of ongoing clinical trials.  Applications selected for funding under this RFA will receive their awards approximately twenty weeks after the application receipt dates. 

This RFA will encourage basic scientists, clinical, and behavioral investigators from academia and industry to work together and provides a cost-efficient approach for collecting information within the framework of ongoing clinical trials.  Additionally, this initiative will strongly encourage but not require that the principal investigators on these ancillary studies be new or junior investigators, with more senior scientists functioning in the co-investigator role.  However, this initiative will not be open to applications where the principal investigator of the ancillary study is also the principal investigator of the parent study.

This Notice is to encourage investigators who believe that they have sufficient expertise to begin considering applying for this RFA program.



Interested parties may contact:

Jamie Varghese-Skipper, Ph.D.
Division of Cardiovascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 9198
Bethesda, MD  20892
Telephone:  (301) 435-0535
FAX:  (301) 480-1454

David Gordon M.D., Ph.D.
Division of Cardiovascular Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 9166
Bethesda, MD  20892
Telephone:  (301) 435-0515
FAX:  (301) 480-7971

Weekly TOC for this Announcement
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