* Article update: As of May 2, 2017, PCORnet released a refreshed view of its data that sheds light on more recent patient encounters than was previously available and includes an expanded list of conditions of interest.
The National Patient-Centered Clinical Research Network, PCORnet, today released early data on its patient demographics and conditions of interest, offering the public a first glimpse of the much-anticipated research network. Founded in 2014 as an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI), PCORnet aims to speed the pace and quality of clinical research in the United States.
“We are thrilled to publicly share a first look at the research scope of PCORnet, a network that promises to transform the landscape of clinical research through large amounts of health data and patient partnerships,” said Rachael Fleurence, PhD, Chair, PCORnet Executive Committee, and PCORI, Program Director. “The achievement of this major milestone is the result of countless individuals who have all shared in our dedication to unite people, clinicians, and health systems in a way that drives faster, real-world insights to help people make informed healthcare decisions.”
PCORnet represents millions of Americans across more than 100 healthcare organizations. The demographic summary released today includes data on up to 41 million individuals who received care at a PCORnet network partner in 2014, stratified by their sex, race, and age[i]. It also details the number of individuals who experienced a medical encounter in 2014 in which they were diagnosed with one of nine conditions of interest based on diagnosis codes[ii] for respiratory conditions, selected malignancies, myocardial infarction, stroke, rheumatoid arthritis, ulcerative colitis, hypertension, renal disease, and influenza/pneumonia, also stratified by sex, race, and age.
As early as spring 2017, researchers will be able to partner with PCORnet to query health records and other data from millions of individuals represented in PCORnet’s Common Data Model (CDM). Momentum and interest continue to build as PCORnet shares this first round of data in preparation for its public launch.
“The enthusiasm for PCORnet underscores the pressing need for a national evidence generation system that puts the interests of people and healthcare stakeholders at the forefront,” said Adrian Hernandez, MD, MHS, Co-Principal Investigator, PCORnet Coordinating Center. “Today’s public announcement of our initial network demographics and conditions is an important milestone that puts us one step closer to our goal of facilitating timely, meaningful answers to people’s everyday health questions.”
Trailblazing a new, people-centered approach to clinical research has been a massive undertaking. The PCORnet team began by successfully creating a Distributed Research Network that is comprised of Patient-Powered Research Networks (PPRNs) that are motivated to play an active role in clinical research and Clinical Data Research Networks (CDRNs) representing health organizations partnering to conduct research as a network. With a robust governance structure in place, PCORnet’s available health data is currently being standardized via the CDM for research use. PCORnet allows network partners to respond to research queries and return aggregate data to the PCORnet Coordinating Center for analysis to protect privacy first.
Now that the network has released its initial demographics and conditions, PCORnet is moving forward with its next major effort: the use of a PCORnet-wide single Institutional Review Board (IRB) approach to significantly reduce the time and expense of conducting multisite studies within the network. This effort will enable PCORnet institutions to use the NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Reliance Platform from the National Institutes of Health instead of the traditional approach of using local IRBs for each research site. PCORnet is pilot-testing the SMART IRB approach in partnership with INVESTED, a PCORnet-designated study of high-dose influenza vaccine. This pilot and related evaluation will inform the adoption of a single IRB approach within PCORnet in 2017.
PCORnet, the National Patient-Centered Clinical Research Network, is an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). The goal of PCORnet is to improve the nation’s capacity to conduct clinical research by creating a large, highly representative network that directly involves patients in the development and execution of research. More information is available at www.pcornet.org.
The Patient-Centered Outcomes Research Institute (PCORI) is an independent, nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continually seeking input from a broad range of stakeholders to guide its work. More information is available at www.pcori.org.
[i] Some individuals may have visited more than one PCORnet network partner and would be counted more than once.
[ii] Diagnosis codes used by PCORnet to define the nine conditions of interest for its demographic summary include ICD-9-CM (International Classification of Diseases, Ninth Revision, Clinical Modification) and SNOMED CT (Systematized Nomenclature of Medicine – Clinical Terms).