Notice of Intent to Publish a Funding Opportunity Announcement for Clinical Centers (CC) for the NHLBI Prevention and Early Treatment of Acute Lung Injury (PETAL) Clinical Trials Network (U01)

Notice Number: NOT-HL-13-167

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

National Heart, Lung, and Blood Institute (NHLBI)

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

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 FOA is provided below.

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 intends that the applicants 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 Network CCs should be led by a pulmonary/critical care clinician-scientist along with an emergency department clinician-scientist or other specialty that can document early access to patients at risk for acute lung injury and related critical illnesses. Each CC application must include one additional satellite institution that can assist with recruitment. Approximately eleven CCs are expected to be awarded.

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

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

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