Strategies to Innovate EmeRgENcy Care Clinical

Transcript:Strategies to Innovate EmeRgENcy Care Clinical:
Strategies to Innovate EmeRgENcy Care Clinical Trials Network SIREN 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) CCC DCC H SIREN Overview Trans-federal collaboration Funding: NINDS, NHLBI, NCATS Consulting: OECR, CCCRP in USAMRMC/DoD Combines resources for emergency care research across federal agencies Draws on experience from NETT, ROC and CCCRP to combine the best features SIREN Objectives Network 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 Performance Rapid initiation, enrollment, data base lock and analysis Quality: expert leadership, mentorship, quality Cost Effective: Rapid network formation, financial 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 NINDS Dr. Clinton Wright Dr. Robin Conwit Dr. Scott Janis Ellen Rosenberg Shanta Rajaram NHLBI Dr. George Sopko Dr. Renee Wong NIH Office of Emergency Care Research Dr. Jeremy Brown NCATS Dr. Todd Wilson Dept. of Defense Lt. Col. Jennifer Hatzfeld The SIREN Network NCATS SIREN Sites Pathway for New Trial PI brings proposal to SIREN executive committee for full discussion SIREN executive committee finds proposal suitable for SIREN network PI applies through NHLBI usual mechanism for clinical trial PI applies through NINDS usual mechanism for clinical trial Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research 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-Initiated Phase II and Above Multi-site Clinical Trials (PAR-16-300 and PAR-16-301) - Frequently Asked Questions January 18, 2017 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)