Change in Patient Recruitment Requirements in RFA-HL-11-030, “Clinical Coordinating Center for the Severe Asthma Research Program”

Notice Number: NOT-HL-11-109

Key Dates
Release Date:  June 11, 2010

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

Purpose

The purpose of this Notice is to modify the language of RFA-HL-11-030.  Given prevalence of severe asthma (5-10% of subjects with asthma), an accrual target of 2250 patients for six clinical centers in the first three award years for six clinical centers is not realistic and may adversely influence potential applicant pool. NHLBI has reduced the requirements in RFA-HL-11-018 (Clinical Centers for the Severe Asthma Research Program) for patient recruitment to an accrual target of 1440 patients for the six clinical centers in the first three years. 

Thus the relevant text in RFA-HL-11-030 for the Clinical Coordinating Center for the Severe Asthma Research Program is now changed to the following:

Section IV. Application and Submission Information;

6. Other Submission Requirements

Clinical Research Costs include (1) Longitudinal Protocol Initiation Costs and (2) Longitudinal Protocol Execution and Close-out Costs at the CCC. For budget planning, assume that 480 children and adults (80 participants per clinical center) will be enrolled across six clinical centers in the shared longitudinal protocol during each of the first three years (N=1440) of the project period.

All other aspects of the FOA remain unchanged. NHLBI apologizes for any confusion generated by these errors.

Inquiries

We encourage your inquiries concerning this Notice and welcome the opportunity to answer questions from potential applicants:

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

Patricia Noel, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 10042
Bethesda, MD 20892-7952
Telephone: (301) 435-0202
FAX: (301) 480-3557
Email: noelp@nhlbi.nih.gov


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