Notice of Intent to Publish Request for Applications (RFAs) for Clinical Centers and a Data Coordinating Center of the Asthma Network (AsthmaNet)

Notice Number: NOT-HL-08-118

Key Dates
Release Date:  April 30, 2008

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 two concurrent RFAs in June 2008 to invite applications to participate as a Clinical Center or Data Coordinating Center in the NHLBI Asthma Network (AsthmaNet), a clinical research network that will develop and conduct multiple clinical trials to address the most important asthma management questions and new treatment approaches in pediatric and adult populations.  AsthmaNet is designed to promote cooperation and coordination, facilitate scientific exchange, provide training opportunities, and leverage resources. The protocols will include clinical trials to evaluate and/or compare existing or new therapeutic approaches to asthma management as well as a limited number of proof of concept studies to advance the development of novel therapies and studies that investigate the mechanistic bases for interventions examined in AsthmaNet.  Up to 9 clinical centers and 1 DCC may be awarded in response to this RFA.

Clinical Centers will be responsible for proposing and prioritizing protocols, participating in protocol development, preparing protocol budgets, conducting the research, analyzing and interpreting research results, and disseminating research findings. Clinical Centers will also be responsible for working with the Data Coordinating Center to develop common definitions and standardization across protocols wherever appropriate.  Each Clinical Center is encouraged to use the multiple principal investigators option (http://grants.nih.gov/grants/multi_pi/index.htm); each Clinical Center is expected to be comprised of a partnership between a lead principal investigator with expertise in pediatric asthma and a lead principal investigator with expertise in adult asthma.  The investigators may be from either the same or different institutions.  To enhance availability of study populations, Clinical Centers may include collaborations with additional recruitment sites at location(s) different from the Clinical Center.

The Data Coordinating Center will require leadership in protocol concept development and feasibility assessment, research design, data analysis, timely implementation and management of collaborative Phase II-III and Phase III, proof of concept and mechanistic research.  The DCC should provide evidence of successful performance as a DCC for multicenter studies (not necessarily in asthma) within the past three years.  The Data Coordinating Center will support protocol development, data collection and analysis, editorial and meeting coordination for manuscript preparation, coordination of the activities of the Steering Committee, Protocol Review Committee, and Data and Safety Monitoring Board, drug acquisition and distribution, and overall study coordination and quality assurance.  The Data Coordinating Center will be responsible for distributing protocol funds to the Clinical Centers for the implementation of protocols.  The Data Coordinating Center will also initiate and coordinate activities to promote standardization of asthma research vocabularies and methodologies and coordinate AsthmaNet activities with NHLBI bioinfomatics programs.

This is a new initiative and the NHLBI encourages all qualified applicants.

Inquiries

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Interested parties are encouraged to contact:

Virginia S. Taggart, M.P.H.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Bethesda MD 20892-7952
Telephone: (301) 435-0202
Email:  taggartv@nhbli.nih.gov 

Robert Smith, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive
Bethesda MD 20892-7952
Telephone: (301) 435-0202
Email:   smithra3@nhlbi.nih.gov


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