1. HMORN Member Organizations Most sites include insurance companies and multi-specialty practices Representing 10 million covered lives Reimbursement models include managed care, FFS, Medicare & Medicaid

2.  Vaccine Safety Datalink (10 sites, CDC, 1990)  Cancer Research Network (14 sites, NCI, 1999)  Developing Evidence to Improve Decisions about Effectiveness (14 sites, AHRQ, 2005)  Cardiovascular Research Network (15 sites, NHLBI, 2007)  Mini-Sentinel Initiative (13+ sites, FDA, 2009)  Mental Health Research Network (10 sites, NIMH, 2010)  Scalable Partnering Network for Comparative Effectiveness Research (10+ sites, AHRQ, 2010)  Surveillance, Prevention, and Management of Diabetes Mellitus (AHRQ, 2010) HMORN Collaborative Research Networks

3. HMORN Virtual Data Warehouse (VDW)  A series of dataset standards and automated processes at each of 15 HMORN sites Each institution’s VDW data remain at their site until a study-specific need arises SAS programs written at one site, can be run quickly with minimal customization at others  Data from all compatible sources, including: Legacy (pre-modern EMR) internal systems Claims (rx, facility, professional) EMR Current areas:Under development: Enrollment/Demographics Utilization (Encounters) Diagnoses Procedures Pharmacy Lab Results Vital Signs Census Death Tumor Infusion (chemo) Orders Dental Network-specific projects: EKG/echocardiogram

4. HMORN Multi-site Study Tools  Multi-center IRB Review IRB Authorization Agreements in place between HMORN sites Lead PI submits application to lead IRB Other sites review and decide whether to cede to lead IRB or retain local review based on perceived risk Lead IRB assumes ongoing oversight for institutions ceding to it  Pre-negotiated sub-award agreement template All sites sign MOU  agree to use as starting place Includes data use terms, up front  Data Sharing HMORN DUA template is customized to fit with HMORN subaward template Bidirectional DUAs in use Distributed research networks in development  Primarily designed and tested for data-only and observational studies

5. HMORN Strengths for Clinical Trials  The Integrated Health Systems Representing 10 million covered lives All sites have EMRs – most using EpicCare  Recruitment Infrastructure Research departments are “covered entities” VDW and other electronic data sources Skilled & dedicated programming and informatics Accurate feasibility assessment and efficient, targeted recruitment  Trial Conduct Efficient electronic communication with health care providers Excellent retention Surveillance for events, obtaining documents, determining costs Disseminating results  Future Innovations: Pragmatic, low-cost trials using EMR to recruit, randomize, intervene and collect follow-up data?