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S trategies to I nnovate E me R g EN cy Care Clinical Trials Network SIREN

S trategies to I nnovate E me R g EN cy 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.

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S trategies to I nnovate E me R g EN cy Care Clinical Trials Network SIREN

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  1. Strategies to Innovate EmeRgENcy Care Clinical Trials Network SIREN

  2. 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)

  3. H H H H H H H H H CCC DCC H

  4. 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

  5. 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

  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/USAMRMC NIH Office of Emergency Care Research Dr. Jeremy Brown NCATS Dr. Todd Wilson Dept. of Defense Lt. Col. Jennifer Hatzfeld NINDS Dr. Clinton Wright Dr. Robin Conwit Dr. Scott Janis Ellen Rosenberg ShantaRajaram • NHLBI Dr. George Sopko Dr. Renee Wong

  8. The SIREN Network 11 Hubs With spokes PARTNERS CCC DCC NINDS NHLBI DoD NCATS NCATS CTSA OECR Central IRB, Central contracting, Monitoring

  9. 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

  10. Pathway for New Trial • PI brings 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 both NHLBI and NINDS Area of study falls within NHLBI PI applies through NINDS usual mechanism for clinical trial PI applies through NHLBI usual mechanism for clinical trial

  11. 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

  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, 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) 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.

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