PCORnet was born out of PCORI’s vision to provide a national health data infrastructure needed to advance a wide range of clinical research. It began with our recognition that the traditional way of conducting health research isn’t sustainable. Budgets for clinical trials research have been escalating rapidly even as resources become tighter and the number of critical questions increases. Moreover, PCORI has championed the idea that we need to better understand how therapies may work differently for different subpopulations rather than only for the average patient, which means we need substantially larger studies.
PCORI saw the tremendous potential for enhancing clinical research in the vast troves of real-world data becoming available with the advent of electronic health records (EHRs), patient portals, and other modes of capturing health data—provided, of course, that the data and patients’ privacy could be securely protected and linked.
Pragmatic Evaluation of Events And Benefits of Lipid-Lowering in Older Adults (PREVENTABLE) is the largest study to date to utilize this innovative research network, but PCORnet’s prowess at generating real-world evidence that answers important patient-centered questions has already been tested and proven through several kinds of research. These include observational studies, a randomized controlled trial, health systems studies, and prep-for-research analyses. PCORI funded several and others have been supported by federal agencies, such as NIH, the Food and Drug Administration (FDA), and the Centers for Disease Control and Prevention, as well as health systems and private companies, among others.
A number of these studies have been designated as the largest to date on their topics. For example, the PCORnet Bariatric Study drew from tens of thousands of medical records to show how commonly used weight loss surgeries compare in terms of safety and keeping weight off. Another study that tapped hundreds of thousands of records of children yielded strong evidence that receiving multiple doses of antibiotics during children’s first two years of life does not appreciably increase their risk of becoming overweight or obese, which could be reassuring to parents and clinicians.
PCORnet studies are also achieving more rapid recruitment to clinical trials using novel ways to reach highly diverse populations that take advantage of features in EHRs. For instance, through just 40 sites, the Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) study was able to quickly reach out to more than 450,000 potential study participants and enroll 15,000 patients. This was accomplished at a pace the researchers describe as five times faster than the typical cardiovascular disease study in the United States.
In preparing to apply for funding for PREVENTABLE, PCORnet researchers queried data from seven of the network’s nine Clinical Research Networks (CRNs) to identify well over 1 million potentially eligible participants at sites throughout the country.
PREVENTABLE will now recruit study participants from approximately 40 healthcare systems in seven of the CRNs and from 60 hospitals in the Veterans Affairs Health Network, which is also a study partner.
This exciting study is the latest and strongest demonstration that PCORnet® has evolved into what PCORI envisioned when we initiated development of this ambitious network with our first investment in late 2013.
Over the past five years, PCORnet’s network partners—including researchers, engaged patients, clinicians, health plan and health system leaders, and data experts—have devised and refined solutions to overcome many barriers that have stymied the use of real-world data for research. Those solutions include the development of faster approaches to contracting and Institutional Review Board review, a common data model that overcomes the lack of direct interoperability of data from differing systems, and a collaborative approach to governance and decision making within the network.
Together, they’ve demonstrated that this innovative network is research ready and open for business. And they’re ready to engage in new challenges. For example, PCORnet’s nine CRNs have now agreed to work with and support the FDA’s Sentinel Initiative for monitoring the safety of drugs and devices as Sentinel Operations Center Collaborators.
We at PCORI commend the PCORnet community for all it has achieved so far and what it has yet to accomplish. As PREVENTABLE indicates, many more answers to important patient-centered questions will come from research using PCORnet.