Strategic Innovation in Emergency Care Research Network (SIREN)
SIREN is a collaborative network enabling high-quality, multi-site clinical trials for patients with neurologic, cardiac, respiratory, hematologic, and trauma emergencies. It consists of Clinical Coordinating Center, Data Coordinating Center, and 11 Clinical Centers with affiliated satellites. The network aims to improve patient outcomes through rapid initiation, enrollment, data analysis, and expert leadership while maintaining cost effectiveness. Integrated logistics and a dedicated staff at NIH and DoD/USAMRMC support SIREN's objectives.
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S Strategies to trategies to I Innovate E Eme meR Rg gEN ENcy Care Clinical cy Care Clinical Trials Network Trials Network SIREN SIREN nnovate
SIREN Overview SIREN will enable conduct of high-quality, multi- site clinical trials to improve the outcomes for patients with neurologic, cardiac, respiratory, hematologic and trauma emergency events. SIREN consists of: Clinical Coordinating Center (CCC) Data Coordinating Center (DCC) 11 Clinical Centers with affiliated satellites (Hubs and Spokes)
H H H H H CCC DCC H H H H H
SIREN Overview Trans-federal collaboration Funding: NINDS, NHLBI, NCATS Consulting: OECR, CCCRP in USAMRMC/DoD Combines resources for emergency care research Combines resources for emergency care research across federal agencies across federal agencies Draws on experience from NETT, ROC and CCCRP to Draws on experience from NETT, ROC and CCCRP to combine the best features combine the best features
SIREN Objectives Network capable of supporting at least 4 concurrent Network capable of supporting at least 4 concurrent large (>1,000 patients), simple pragmatic trials large (>1,000 patients), simple pragmatic trials In ED and pre In ED and pre- -hospital emergency settings. hospital emergency settings. Neurological (except stroke), cardiovascular, Neurological (except stroke), cardiovascular, pulmonary, hematological, trauma. pulmonary, hematological, trauma. High Performance High Performance Rapid initiation, enrollment, data base lock and Rapid initiation, enrollment, data base lock and analysis analysis Quality: expert leadership, mentorship, quality Quality: expert leadership, mentorship, quality Cost Effective: Rapid network formation, financial Cost Effective: Rapid network formation, financial support related to trial performanc support related to trial performance
SIREN New Trial integrated logistics CCC: central IRB, master trial contracts, overall enrollment, recruitment plan. DCC: standardized CRFs, efficient and user friendly data collection methods, risk based monitoring, efficient data base lock. Hubs and Spokes: access to large diverse population, local enrollment and recruitment plan, strong relationship with EMS, and with specialists and subspecialists.
SIREN Staff at NIH & DoD/USAMRMC NIH Office of Emergency Care Research Dr. Jeremy Brown NINDS Dr. Clinton Wright Dr. Robin Conwit Dr. Scott Janis Ellen Rosenberg Shanta Rajaram NCATS NCATS Dr. Todd Wilson NHLBI Dr. George Sopko Dr. Renee Wong Dept. of Defense Lt. Col. Jennifer Hatzfeld
The SIREN Network PARTNER PARTNERS S 11 Hubs With spokes NINDS CCC CCC DCC DCC NHLBI DoD NCATS NCATS NCATS CTSA CTSA OECR Central IRB, Central contracting, Monitoring
SIREN Sites U Washington U Minnesota MGH Med Coll Wisconsin Wayne State Temple UC Davis U Pitt Philadelphia UCSF U Utah Hopkins U Colorado U Cincinnati Washington Univ UCLA MUSC DCC Emory Census Region: West Midwest South Northeast
Pathway for New Trial PI brings proposal to proposal to SIREN executive committee for full discussion SIREN executive committee finds proposal suitable for SIREN network Area of study falls within NINDS Area of study falls within NHLBI Area of study falls within both NHLBI and NINDS PI applies through NINDS usual mechanism for clinical trial PI applies through NHLBI usual mechanism for clinical trial
Final NIH Policy on the Use of a Single Institutional Final NIH Policy on the Use of a Single Institutional Review Board for Multi Review Board for Multi- -Site Research Site Research sIRB sIRB is the selected IRB of record that conducts the ethical review for participating sites of the multi-site study NOT-OD-16-094 and NOT-OD-16-109 http://grants.nih.gov/grants/guide/notice- files/NOT-OD-16-094.html Guidance on how costs associated with sIRBs may be charged as direct versus indirect costs can be found in Guide Notice NOT-OD-16-109
New FOAs for Investigator New FOAs for Investigator- -Initiated Phase II and Above Multi Initiated Phase II and Above Multi- - site Clinical Trials (PAR site Clinical Trials (PAR- -16 16- -300 and PAR 300 and PAR- -16 Asked Questions Asked Questions January 18, 2017 16- -301) 301) - - Frequently Frequently https://www.nhlbi.nih.gov/research/funding/new-foas- investigator-initiated-phase-ii-and-above-multi-site-clinical- trials-par-16-300-and-par-16 The NIH requirement for a single IRB on studies it funds applies to all competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after May 25, 2017. Ongoing, non-competing awards will not be expected to comply with this policy until the grantee submits a competing renewal application. The NHLBI FOAs for multi-site clinical trials will be updated in the future to reflect the new requirement and its effective date. In the meantime, applicants may consider the use of a single IRB in advance of this policy s effective date.
