RFA-NS-16-015: Network for Emergency Care Clinical Trials: Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN) – Data Coordinating Center (DCC) (U24)
LOI: 30 days prior to application deadline
Internal Deadline: April 22, 2016, 5pm
External Deadline: June 1, 2016, 5pm
Type: Cooperative Agreement
Estimated Number of Awards: 1
Anticipated Amount: Application budgets should not exceed a maximum of $430,000 direct costs for Year 1 (2017), and $250,000 direct costs per year in Years 2-5 of SIREN.
Cost Sharing: This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Submission Process: PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://app.wizehive.com/webform/USCgrants
Materials to submit:
- Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt.).
- CV – (5 pages maximum)
Who May Serve as PI:
Standard NIH eligibility requirements.
The purpose of this funding opportunity announcement (FOA) is to solicit applications for the Data Coordinating Center (DCC) of the Strategies to Innovate EmeRgENcy Care Clinical Trials Network (SIREN). SIREN will provide a robust and readily accessible infrastructure for rapid implementation and high quality performance of clinical trials in a breadth of emergency indications related to neurology (e.g., status epilepticus, traumatic brain or spinal cord injury, not cerebrovascular because StrokeNet is the primary network for stroke clinical research), cardiovascular (e.g., cardiac arrest, decompensation of cardiac failure), respiratory (e.g., respiratory arrest, pulmonary embolus), hematology (e.g., exsanguination) and trauma. SIREN will consist of one Clinical Coordinating Center (CCC), one DCC and up to 15 clinical centers with their satellite sites (Hub and Spoke clinical site model). The SIREN infrastructure should be sufficient for implementation of at least four simultaneous large (>1,000 patient), simple, pragmatic trials in the Emergency Department (ED) and pre-hospital (e.g., transportation, EMS) settings. The purpose of SIREN is to advance emergency medicine by efficiently enabling performance of rigorous comparative effectiveness studies and assessments of novel therapeutic interventions.
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 DCC will contribute to this objective by performing clinical trial data management, data quality control, data monitoring and statistical analyses for SIREN. The DCC is responsible for the SIREN Data Safety Monitoring Board (DSMB) and preparing reports for external regulatory and oversight groups. The DCC is encouraged to be innovative in improving clinical trial efficiency and quality.
The Clinical Coordinating Center (CCC) will provide scientific and organizational leadership to SIREN to achieve both efficiency and excellence in its implementation and performance of clinical trials. Responsibilities of the CCC will specifically include the SIREN central Institutional Review Board (IRB), master contract agreements with the clinical sites for trial performance, recruitment plans, enrollment tracking and quality improvement. The role and responsibilities of the CCC are described more fully in RFA-NS-16-014.
The Data Coordinating Center (DCC) will provide scientific and organizational leadership to SIREN in all aspects of data management, data quality, statistical design and statistical analysis. Responsibilities of the DCC particularly include management and support of the DSMB, and reporting to regulatory authorities (e.g., central IRB, FDA). The role and responsibilities of the DCC are described more fully below (see DCC: Roles and Responsibilities).
The Hubs will provide scientific leadership and conduct clinical trials in the ED and pre-hospital (e.g. ambulance, other transport) settings. A Hub is envisioned as a regional academic medical center or tertiary care facility that will enroll patients itself along with providing clinical and organizational leadership to its network of 2-10 satellite sites (Spokes). The Hub must be capable of providing physicians with expertise in emergency medicine, neurology, cardiology, pulmonology, hematology, general surgery, trauma surgery, neurosurgery, cardiovascular surgery or other subspecialties, as required. The roles and responsibilities of the Hubs and Spokes are described more fully in RFA-NS-16-016.
Visit our Institutionally Limited Submission webpage for updates and other announcements.