Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) – Network Clinical Center (Hub) (U24)

RFA-NS-16-016
Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) – Network Clinical Center (Hub) (U24)emergency medicine
Department of Health and Human Services
National Institutes of Health

Background

There is a clear public health imperative to stimulate and support research that improves care and clinical outcomes.  According to the Centers for Disease Control and Prevention (CDC), unintentional injuries are the leading cause of death for Americans under the age of 45.  In 2011, the most recent year with data published by the CDC, there were 136 million ED visits in the United States, accounting for about 4% of all health care spending.  Of the 136 million visits, 12%, or some 16 million, resulted in a hospital admission. About half of the top 10 reasons for presentation at an ED (i.e. chest pain, headache, cough, back symptoms, shortness of breath) are neurologic or heart, lung, blood (HLB) conditions and together these make up about 17% of all ED visits.

Clinical emergency care research covers all stages of the provision of emergency care, from pre-hospital emergency medical services to hospital EDs, trauma systems and emergency operative interventions. The principles of emergency care –making accurate and timely diagnoses and interventions– are independent of the disease, organ system and venue. The ED is the common entry portal for more than half of all hospitalized patients. Although dysfunction may start in one organ system, in a critical situation other organs can become rapidly involved, so successful care must address multiple systems. These characteristics of emergency care justify establishment of SIREN as a single, adaptable network able to support clinical trials in the multiple indications of neurology, cardiology, respiratory, hematology and trauma.

Research Objectives

SIREN will harness multidisciplinary emergency care expertise to provide scientific leadership and the infrastructure required to conduct large, simple, pragmatic clinical trials to advance knowledge of optimal patient management in the prehospital and ED setting.  In addition, the network may be called upon to include other venues where post emergency care is provided (such as critical care units, the operating room or other hospital settings) when required by the needs of peer-reviewed, meritorious clinical trials.

The Hubs will contribute to these objectives by exemplary execution of clinical trials, including rapid start up and enrollment, protection of human subjects, and provision of accurate data in a timely fashion. To facilitate trial performance, the Hubs will select and provide oversight and leadership to satellite clinical sites (“Spokes”).

General Information

Document Type: Grants Notice
Funding Opportunity Number: RFA-NS-16-016
Funding Opportunity Title: Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) – Network Clinical Center (Hub) (U24)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Health
Category Explanation:
Expected Number of Awards: 10
CFDA Number(s): 93.837 — Cardiovascular Diseases Research
93.838 — Lung Diseases Research
93.839 — Blood Diseases and Resources Research
93.853 — Extramural Research Programs in the Neurosciences and Neurological Disorders
Cost Sharing or Matching Requirement: No
Posted Date: Mar 08, 2016
Last Updated Date: Mar 09, 2016
Original Closing Date for Applications: Jun 01, 2016  
Current Closing Date for Applications: Jun 01, 2016  
Archive Date: Jul 02, 2016
Estimated Total Program Funding:
Award Ceiling:
Award Floor:

Eligibility

Eligible Applicants:
County governments
City or township governments
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
State governments
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
Small businesses
Independent school districts
Special district governments
For profit organizations other than small businesses
Public and State controlled institutions of higher education
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Private institutions of higher education
Native American tribal organizations (other than Federally recognized tribal governments)
Additional Information on Eligibility: Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Additional Information

Agency Name: National Institutes of Health
Description: The purpose of this funding opportunity announcement (FOA) is to invite applications for Clinical Centers (Hubs) in Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN).SIREN will enable conduct of high-quality, multi-site clinical trials to improve the outcomes for patients with neurologic, cardiac, respiratory, and hematologic, and trauma emergency events. SIREN will consist of one Clinical Coordinating Center (CCC), one Data Coordinating Center (DCC) and up to 10 clinical centers (Hubs). A Hub will typically be an academic center or tertiary referral center which will actively enroll patients into every clinical trial performed in SIREN, regardless of disease focus.A Hub will additionally provide scientific leadership and administrative oversight to its multiple satellite sites (“Spokes”).Together the Hub and Spokes will provide access to a large and varying patient population for clinical trials. SIREN will implement a total of at least four large (1,000 patient) simple, pragmatic clinical trials in the emergency department and pre-hospital settings. The clinical trials will be meritorious, peerreviewed projects which will be awarded under separate funding announcements.
Link to Additional Information: http://grants.nih.gov/grants/guide/rfa-files/RFA-NS-16-016.html
Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH OER Webmaster FBOWebmaster@OD.NIH.GOV
If you have any problems linking to this funding announcement, please contact the NIH OER Webmaster

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