E me R g EN cy Care Clinical Trials Network SIREN SIREN Overview SIREN will enable conduct of highquality multisite clinical trials to improve the outcomes for patients with neurologic cardiac respiratory hematologic and trauma emergency events ID: 1009888
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1. Strategies to Innovate EmeRgENcy Care Clinical Trials Network SIREN
2. SIREN OverviewSIREN 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)
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4. SIREN OverviewTrans-federal collaborationFunding: NINDS, NHLBI, NCATSConsulting: OECR, CCCRP in USAMRMC/DoDCombines resources for emergency care research across federal agenciesDraws on experience from NETT, ROC and CCCRP to combine the best features
5. SIREN ObjectivesNetwork capable of supporting at least 4 concurrent large (>1,000 patients), simple pragmatic trials In ED and pre-hospital emergency settings.Neurological (except stroke), cardiovascular, pulmonary, hematological, trauma.High PerformanceRapid initiation, enrollment, data base lock and analysisQuality: expert leadership, mentorship, quality Cost Effective: Rapid network formation, financial support related to trial performance
6. 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.
7. SIREN Staff at NIH & DoD/USAMRMCNINDS Dr. Clinton WrightDr. Robin Conwit Dr. Scott JanisEllen RosenbergShanta RajaramNHLBI Dr. George SopkoDr. Renee Wong NIH Office of Emergency Care ResearchDr. Jeremy BrownNCATS Dr. Todd WilsonDept. of Defense Lt. Col. Jennifer Hatzfeld
8. The SIREN NetworkCCCDCCNCATSCTSACentral IRB, Central contracting,MonitoringNHLBININDSPARTNERS11 HubsWith spokesOECRDoDNCATS
9. SIREN SitesCensus Region: West Midwest South Northeast U WashingtonUCSFU ColoradoUCLAUC DavisU UtahU MinnesotaMed Coll WisconsinWashington UnivWayne StateU CincinnatiEmoryMUSC DCCHopkinsU PittPhiladelphiaMGHTemple
10. Pathway for New TrialPI brings proposal to SIREN executive committee for full discussion SIREN executive committee finds proposal suitable for SIREN networkArea of study falls within both NHLBI and NINDS Area of study falls within NINDSArea of study falls within NHLBI PI applies through NHLBI usual mechanism for clinical trial PI applies through NINDS usual mechanism for clinical trial
11. Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site ResearchsIRB 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-16-109http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.htmlGuidance on how costs associated with sIRBs may be charged as direct versus indirect costs can be found in Guide Notice NOT-OD-16-109
12. New FOAs for Investigator-Initiated Phase II and Above Multi-site Clinical Trials (PAR-16-300 and PAR-16-301) - Frequently Asked Questions January 18, 2017https://www.nhlbi.nih.gov/research/funding/new-foas-investigator-initiated-phase-ii-and-above-multi-site-clinical-trials-par-16-300-and-par-16The 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.