Launching PCORnet, a national patient-centered clinical research network

The Patient-Centered Outcomes Research Institute (PCORI) has launched PCORnet, a major initiative to support an effective, sustainable national research infrastructure that will advance the use of electronic health data in comparative effectiveness research (CER) and other types of research. In December 2013, PCORI's board of governors funded 11 clinical data research networks (CDRNs) and 18 patient-powered research networks (PPRNs) for a period of 18 months. CDRNs are based on the electronic health records and other electronic sources of very large populations receiving healthcare within integrated or networked delivery systems. PPRNs are built primarily by communities of motivated patients, forming partnerships with researchers. These patients intend to participate in clinical research, by generating questions, sharing data, volunteering for interventional trials, and interpreting and disseminating results. Rapidly building a new national resource to facilitate a large-scale, patient-centered CER is associated with a number of technical, regulatory, and organizational challenges, which are described here.

[1]  Steven J. Jacobsen,et al.  The Vaccine Safety Datalink: A Model for Monitoring Immunization Safety , 2011, Pediatrics.

[2]  George Hripcsak,et al.  Caveats for the use of operational electronic health record data in comparative effectiveness research. , 2013, Medical care.

[3]  Bruce H Fireman,et al.  Confounding Adjustment in Comparative Effectiveness Research Conducted Within Distributed Research Networks , 2013, Medical care.

[4]  Stephen B. Johnson,et al.  Central challenges facing the national clinical research enterprise. , 2003, JAMA.

[5]  Hyeon-Eui Kim,et al.  Identifying Appropriate Reference Data Models for Comparative Effectiveness Research (CER) Studies Based on Data from Clinical Information Systems , 2013, Medical care.

[6]  M. Solomon,et al.  Ethical oversight of research on patient care. , 2013, The Hastings Center report.

[7]  Edm Forum.  Building the Electronic Clinical Data Infrastructure to Improve Patient Outcomes: CER Project Profiles , 2012 .

[8]  Amy P Abernethy,et al.  Improving health care efficiency and quality using tablet personal computers to collect research-quality, patient-reported data. , 2008, Health services research.

[9]  Marsha A Raebel,et al.  Design considerations, architecture, and use of the Mini‐Sentinel distributed data system , 2012, Pharmacoepidemiology and drug safety.

[10]  Stephanie M. Fullerton,et al.  Research Practice and Participant Preferences: The Growing Gulf , 2011, Science.

[11]  Richard Platt,et al.  Ethics, regulation, and comparative effectiveness research: time for a change. , 2014, JAMA.

[12]  Jill Sage,et al.  The Patient-Centered Outcomes Research Institute. , 2014, Bulletin of the American College of Surgeons.

[13]  Sengwee Toh,et al.  Multivariable confounding adjustment in distributed data networks without sharing of patient‐level data , 2013, Pharmacoepidemiology and drug safety.

[14]  Gila Neta,et al.  Use of PRECIS ratings in the National Institutes of Health (NIH) Health Care Systems Research Collaboratory , 2016, Trials.

[15]  J. Selby,et al.  Network News: Powering Clinical Research , 2013, Science Translational Medicine.

[16]  Sarah E. Daugherty,et al.  Patient-powered research networks: building capacity for conducting patient-centered clinical outcomes research , 2014, J. Am. Medical Informatics Assoc..

[17]  R. Platt,et al.  Distributed Health Data Networks: A Practical and Preferred Approach to Multi-Institutional Evaluations of Comparative Effectiveness, Safety, and Quality of Care , 2010, Medical care.

[18]  R. Platt,et al.  Developing the Sentinel System--a national resource for evidence development. , 2011, The New England journal of medicine.

[19]  D. Blumenthal,et al.  The "meaningful use" regulation for electronic health records. , 2010, The New England journal of medicine.

[20]  Sarah M. Greene,et al.  The role of research in integrated healthcare systems: the HMO Research Network. , 2004, The American journal of managed care.