Flash back to 2016, when Hamilton had just premiered on Broadway, the Rio Olympics were in full swing, and Duke University cardiologist Neha Pagidipati first heard about a relatively new network of clinical research networks capable of producing granular insights from large, representative patient datasets across the U.S. At the time, Neha was trying to understand national patterns of weight management, and PCORnet® was one of the few available data sources capable of capturing a tremendous sample size without loss of important detail she needed to deliver on her study’s goals.
“PCORnet immediately caught my interest because it could capture lab results, blood pressure, and body mass index (BMI) data at scale,” said Neha. “With support from 11 sites participating in PCORnet, our study team successfully teased out associations between weight change and cardiometabolic risk factors in a massive, real-world population of U.S. adults with overweight or obesity. The results shed much-needed light on these conditions that impact millions of people living in the United States.”
The observational study, which looked at outcomes related to more than 800,000 people over a 12-month period, addressed exactly the kind of evidence gaps the Network was designed to answer when it was first funded in 2014.
While randomized controlled trials (RCTs) have long been the gold standard of clinical research, they typically include smaller, carefully selected, homogenous populations and are undertaken in specialized care settings. For these reasons, they often don’t illuminate all the information patients need to know, like how an intervention fares in real-world settings and among people with a wider range of circumstances.
PCORnet was developed with support from the Patient-Centered Outcomes Research Institute (PCORI) to address these gaps by serving as a national resource that brings together data from everyday health encounters, research expertise, and patient partnership. Observational research fueled by the Network complements RCTs with real-world insights that drive improved health outcomes across the U.S. PCORnet also supports more efficient participant recruitment and other services to advance the conduct of RCTs.
From big idea to proven national resource
The groundbreaking nature of PCORnet meant there was no blueprint for building the Network infrastructure. In 2016, when Neha first used the Network, the PCORnet® Common Data Model (CDM) was still in development. In fact, at the time, BMI codes were not yet fully mapped, meaning Neha’s study had to work through some kinks to align the disparate ways of coding BMI in medical records across the clinical research networks (CRNs) comprised of dozens of health systems and clinics that are participating in PCORnet. PCORnet® CRNs also had not worked with one another long enough to establish seamless processes and advanced knowledge of the data available for research.
Today, all that has changed.
“PCORnet has made progress in leaps and bounds from its early days in 2016,” said Neha. “The organization of the Network is smoother, and results are much more accelerated, vetted by PCORnet® CRNs who have worked together for years. The data available is also much more advanced. Today’s PCORnet® CDM maps a wealth of rich data fields to support observational research, and it is growing all the time.”
Currently working on her fourth PCORnet-supported study, Neha knows the Network better than most. Her latest research is comparing the safety and effectiveness of two glucose-lowering drugs in patients with type 2 diabetes. Neha wanted to include a relatively high number of patients taking these drugs who also have diabetic kidney disease (DKD), which drove her to once again select PCORnet as her research network of choice.
“We needed a network that could not only capture lab data across a broad enough population to meet our DKD participant target, but also allowed us to track long-term outcomes in these patients,” said Neha. “Frankly, PCORnet resources offer the only networked datasets out there that could support this research.”
In addition to the safety and efficacy questions, Neha’s study is also trying to understand why patients with type 2 diabetes may not receive guideline-recommended screening for DKD. It is the largest study to date asking these important questions, which is significant considering the high prevalence of type 2 diabetes and broad use of glucose-lowering drugs across the nation.
Neha says demand for PCORnet will only continue to increase as communities reap the benefits this kind of patient-centered, real-world research offers.
“We won’t find the answers diverse communities need if we only look to studies with a small number of homogenous participants,” said Neha. “Real-world, patient-centered answers start to surface only when we look across the country with a wide lens, capturing all types of people in all types of circumstances — this is the true power of PCORnet, and its infrastructure delivers.”