Notice Number: NOT-NS-15-021

Key Dates
Release Date: May 5, 2015
Estimated Publication Date of Announcement: November 2015
First Estimated Application Due Date: March 2016
Earliest Estimated Award Date: December 2016
Earliest Estimated Start Date: December 2016

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Advancing Translational Sciences (NCATS)

Purpose

The National Institute of Neurologic Disorders and Stroke (NINDS), the National Heart, Lung and Blood Institute (NHLBI), the National Center for Advancing Translational Science (NCATS), the Office of Emergency Care Research (OECR) in the National Institute of General Medical Sciences (NIGMS), and the Defense Medical Research and Development Program for Combat Casualty Care (DMRDP) intend to publish a Funding Opportunity Announcement (FOA) to solicit applications for an emergency care clinical trials network entitled Strategies to Innovate EmeRgENcy Care Clinical Trials (SIREN). The network will be composed of a Clinical Coordinating Center (CCC), a Data Coordinating Center (DCC), and multiple Regional Clinical Centers with their linked clinical sites. The network will be charged with executing trials of high impact for the treatment of patients with neurological, cardiac, pulmonary, hematologic and traumatic medical and surgical emergencies. Applications for SIREN trials will be solicited from the national scientific community. Investigator-initiated clinical trials that are considered highly meritorious by peer-review will be funded separately for execution by the network, in some cases coordinated with additional trial-specific sites.

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

The FOA is expected to be published in November, 2015 with an expected application due date in March, 2016.

This FOA will utilize the U24 activity code.

Research Initiative Details

This Notice encourages investigators with expertise in emergency care research, particularly neurologic, heart, lung, blood and trauma related indications, to begin to consider applying for this new FOA.

The SIREN network will be responsible for simultaneously executing at least 4 large, randomized, clinical trials that focus on improving care of patients with emergency conditions relevant to the mission of NINDS, NHLBI and the Defense Medical Research and Development Program for Combat Casualty Care (DMRDP) presenting to the pre-hospital or emergency department setting. The Regional Clinical Centers will work collaboratively with the SIREN Clinical and Data Coordinating Centers, including use of the central IRB and master trial agreements formed by the Clinical Coordinating Center in coordination with the new Trial Innovation Centers being set up by the National Center for Advancing Translational Science. Regional Coordinating Centers are expected to establish and work with subsidiary clinical sites, the identity and number of which may vary from protocol to protocol. The SIREN Regional Clinical Centers will be responsible for patient recruitment and treatment for SIREN studies

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

Robin Conwit, MD
National Institute Neurologic Disorders and Stroke (NINDS)
Telephone: 301-496-3299
Email: conwitr@ninds.nih.gov

Monica Shah, MD, FACC
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0504
Email: shahmr@nhlbi.nih.gov

Jeremy Brown, MD
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-4481
Email: jeremy.brown@nih.gov