NOT-HL-13-168: Notice of Intent to Publish a Funding Opportunity Announcement for a Clinical Coordinating Center (CCC) for Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network (U01)

Notice of Intent to Publish a Funding Opportunity Announcement for a Clinical Coordinating Center (CCC) for Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network (U01)

Notice Number: NOT-HL-13-168

Key Dates

Release Date: February 20, 2013
Estimated Publication Date of Announcement: April 2013
First Estimated Application Due Date: July 2013
Earliest Estimated Award Date: March 2014
Earliest Estimated Start Date: March 2014

Issued by

National Heart, Lung, and Blood Institute (NHLBI)

Purpose

The National Heart, Lung, and Blood Institute intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for institutions to serve as the Clinical Coordinating Center (CCC) for a new multi-center clinical trials network that will develop and test prevention or early treatment strategies for Acute Lung Injury. The new network, the Prevention and Early Treatment of Acute Lung Injury (PETAL) Network is expected to consist of one CCC which will be responsible for supporting all administrative and coordinating functions associated with PETAL. A separate FOA will invite applications for approximately eleven Clinical Centers.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

This FOA is expected to be published in the spring of 2013 with an expected application due date in the summer of 2013.

This FOA will utilize the U01 activity code. An overview of the planned FOAs is provided below.

Research Initiative Details

This Notice encourages investigators with expertise and insights into the area of clinical trials in patients with or at risk for Acute Lung Injury (ALI) (also known as ARDS by the new Berlin definition) to begin to consider applying for this new FOA.

The NHLBI Clinical Trials Network for the Prevention and Early Treatment of ALI (PETAL Network) will develop and conduct randomized controlled clinical trials to prevent or treat, and/or improve the outcome of patients with, or who are at risk for developing ALI.

Numerous observational studies suggest that acute lung injury and ARDS can be prevented and outcomes improved in patients at risk of, but without established disease. Recommendations from the critical care community stress using multidisciplinary approaches and studies of pre-ICU factors that will permit early identification and intervention in the emergency department or other locations within the hospital. This new initiative will require a collaborative team approach that will bring together pulmonary/critical care investigators, with experts in other relevant specialties including, but not limited to, emergency department physicians, trauma, sepsis, surgery, or infectious disease medicine.

PETAL CCC applicants should have experience in all aspects of initiating and running a complex clinical trials network. The CCC must be led by a PD/PI who is a statistician experienced with clinical trials design, analysis, and management, and a pulmonary/critical care clinician-scientist who will advise and monitor the clinical aspects of the Network. The CCC will also be expected to develop and manage a biorepository of clinical samples obtained from patients participating in the clinical trials. One CCC will be awarded.

The Network is expected to develop and participate in a streamlined Institutional Review Board model that will be designed and implemented by the steering committee of the Network.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Andrea L. Harabin, Ph.D.
Division of Lung Diseases
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Suite 10162, MSC 7952
Bethesda, MD 20892-7952
Telephone: 301-435-0222
Email: Andrea.harabin@nih.gov