Three years ago, PCORI began an ambitious journey to address an urgent national need: creating a platform that could help us conduct patient-centered comparative clinical effectiveness research (CER) and related studies faster, less expensively, and with more power than previously possible. That’s when our Board of Governors approved an initial $100 million in funding for PCORnet, the National Patient-Centered Clinical Research Network.
In launching PCORnet, we saw the rare opportunity to truly transform the way research is done by harnessing the power of electronic health record (EHR) information covering tens of millions of patients, along with claims data and information reported by patients themselves. These information streams are available through PCORnet’s large distributed “network of networks” that embeds research within delivery systems and engages patients and clinicians within those systems in decisions about what to study. To ensure this initiative addresses the real-world needs of patients and those who care for them, we insisted it be developed and run by patients, researchers, clinicians, and health system leaders.
PCORnet was a natural fit for PCORI, which was created to fund CER studies that can help patients, their families, clinicians, payers, and other healthcare stakeholders make better-informed decisions, focusing on outcomes that patients tell us are important. Our Board had a vision that PCORnet could serve as a resource to spread this kind of research well beyond the studies PCORI itself funds.
Today, we are on the path to realizing PCORnet’s promise. What’s more, we celebrate the natural next step in fulfilling our Board’s vision for this network to become a resource for the nation, open for use by all interested researchers and research funders.
At Health Datapalooza, April 27–28 in Washington, DC, representatives from PCORnet, the National Patient-Centered Clinical Research Network, will discuss integrating patients’ voices into data. Patient panelists will describe how patient engagement has been, and continues to be, vital in developing PCORnet’s research infrastructure and data governance. And a researcher will discuss how PCORnet’s Collaborative Research Groups work with patients to expand the patient-centered data infrastructure to allow cross-network collaboration.
PCORI's Investment in a National Research Resource
PCORnet’s development began in December 2013, when our Board approved funding for an initial group of participating networks. These included both health system-based Clinical Data Research Networks (CDRNs) and Patient-Powered Research Networks (PPRNs). PCORnet’s 18-month first phase of development involved 29 partner networks; a three-year second phase involving funding for 33 networks began in fall 2015 and continues through mid-2018.
To date, our Board has approved $324 million in funding for PCORnet’s technical infrastructure and to support the development and expansion of the participating networks. The Board also has approved $64 million to support 17 studies to demonstrate PCORnet’s research capacities while answering important patient-centered questions. These include PCORI-funded studies on preventing recurrent heart attacks and strokes in people with heart disease and improving obesity prevention and treatment. Other projects include one jointly funded by PCORI and the Crohn’s and Colitis Foundation and additional studies funded by the National Institutes of Health (NIH), Centers for Disease Control and Prevention, and Agency for Healthcare Research and Quality.
In launching PCORnet, we saw the rare opportunity to truly transform the way research is done.
PCORnet is proving itself increasingly capable of allowing investigators to conduct a variety of research-related activities, including pre-research feasibility queries as well as enabling observational and interventional studies. Through its partner networks, PCORnet facilitates access to standardized data from more than 130 health systems and patient groups. These data represent about 110 million patients who have had at least one medical encounter in the past five years. To safeguard patient privacy and security, the data do not go into a central database but remain with the networks and institutions where they originate, subject to the protections in place there.
In addition to watching PCORnet’s capabilities mature, I’ve been excited to see some of the innovative work that partner networks have been doing individually and in groups. A number of the PPRNs are making it easier for network participants to retrieve their own EHR data through existing online portals. The PPRNs then offer them an immediate option to make these data available for research.
Some health systems involved in the CDRNs are looking at ways to use aggregated EHR data in making individual clinical decisions. The PORTAL network, for example, uses EHR data from nearly 12 million patients to assess the effectiveness of different treatment options; it then makes that information available to patients to help them make clinical decisions.
Meanwhile, the Pennsylvania-based Geisinger Health System, which is part of PCORnet’s PaTH network, is capturing genetic test results in its EHRs to make that information available for research. Other partner networks are working with health systems on fast-turnaround studies that leverage EHR and other systems–based data to answer questions. And an NIH-funded study of adults with influenza is piloting the use of a PCORnet-wide single institutional review board, which should significantly reduce the time and expense of conducting multisite collaborative clinical research studies.
An Exciting Time for PCORnet
All of us at PCORI and our PCORnet colleagues are proud of what this initiative has achieved and confident we’ll see many more accomplishments as its second phase continues. We’re also excited by another milestone: the birth of a new nonprofit organization committed to PCORnet’s long-term sustainability and growth. A long-term plan for PCORnet’s sustainability is a vision our Board has had ever since we launched the project.
The People-Centered Research Foundation (PCRF), which evolved from a work group of researchers within PCORnet, was formed in March as a private nonprofit that builds on the successes of PCORnet and furthers its mission as a sustainable platform for efficient, innovative research. PCORI’s principles of patient-centeredness and engagement are deeply embedded within PCRF. Former FDA Commissioner Robert Califf, MD, one of those who originally helped us advance the PCORnet concept, chairs PCRF’s distinguished Board of Directors, which includes representatives from patient communities, health plans, and the life sciences industry.
As Califf said in a note to the PCORnet community last month, PCRF is committed to accelerating people-driven research that engages patients, researchers, and other stakeholders in the design, conduct, dissemination, and implementation of studies that can lead to improved population health. This goal aligns fully with the approach to research PCORI has followed since we began funding studies.
The future is very promising for PCORnet and PCRF, through PCORnet’s current phase of development and beyond.
The future is very promising for PCORnet and PCRF, through PCORnet’s current phase of development and beyond. It was always our Board’s vision for PCORnet to become a self-sustaining resource for the nation, with planning toward that goal to begin during the network’s second phase of development.
PCRF will work in parallel and in collaboration with PCORnet and its participating networks to make PCORnet self-sustaining, even as the networks continue to use their current PCORI funding to build additional research infrastructure. To support PCORnet and PCRF as they move forward, our Board recently approved up to $25.4 million to PCRF for further infrastructure and capacity building.
Through PCRF and its leaders, we’re confident that PCORnet will find substantial opportunities to secure external funding to support new studies and continue to advance the network’s infrastructure, allowing it to expand into new areas of patient-centered research. The goal is that PCORnet, through PCRF, will effectively and quickly evolve into a national evidence-generation resource available to all interested in using it. Researchers, delivery systems, health plans, and other funders will find an open door to supporting and using PCORnet’s infrastructure while advancing its commitment to patients’ involvement every step of the way.
We at PCORI are confident that the healthcare community will see PCORnet as a valuable research platform. We believe its innovative use of health data and patient engagement offers the nation a model of research that generates important findings to positively influence clinical practice and care delivery. This influence, in turn, will lead to improving health and health care.