Guest Blog: PCORI’s Big Idea for Big Data

Joe Selby and Rachael Fleurence | May 31, 2013

Talk about “Big Data” is common lately, especially in healthcare. After all, there are few fields where more data are collected and consulted on a daily basis—and where there is such widespread agreement that the information isn’t being used as well as it could be to improve outcomes.Many have tackled this challenge. But given all of the complex issues faced daily by patients and those who care for them, much more remains to be done.

Many of us recognize that, as a nation, our current way of conducting healthcare research isn’t sustainable. Research budgets are tightening, the cost of clinical trials is accelerating, and new data are revealing ever greater nuances to consider in how we categorize and treat patients.

In short, we have more research questions than ever before and fewer resources to put toward finding answers.

For research to more effectively serve patients, clinicians and others who make health care decisions, we need a new model that brings healthcare systems, clinicians, and patients themselves fully into the process of using data to improve health and healthcare outcomes.

Patient-Centered Outcomes Research Institute advances comparative effectiveness research

Numerous organizations have contributed to laying the foundation for this effort. These include the Office of the National Coordinator (ONC), Agency for Healthcare Research and Quality, National Institutes of Health, Food and Drug Administration (FDA), and U.S. Department of Veterans Affairs (VA). But the task is difficult.

Now, we at the Patient-Centered Outcomes Research Institute are building on those efforts to launch a major next step – investing $68 million in initial funding to develop a National Patient-Centered Clinical Research NetworkExternal Links Disclaimer.  We see this initiative as providing a much-needed national data infrastructure that will advance patient-centered comparative effectiveness research.

We announced our plans on April 23 at the National Press Club in Washington, D.C., with a roundtable featuring representatives from leading healthcare stakeholder groups. The panelists—from the Association of American Medical Colleges, America’s Health Insurance Plans, National Patient Advocate Foundation, Pharmaceutical Research and Manufacturers of America, FDA and ONC—discussed the unique value our initiative can provide.

Patient-centered comparative effectiveness research comes with challenges

They also described the challenges we face, including:

  • data standards and systems inter-operability,
  • protecting the security of the data and the privacy of patients.
  • developing the capacity to conduct randomized studies in typical clinical care settings

The Patient-Centered Outcomes Research Institute ’s challenge is to take the data from existing, real-world clinical settings, and to actively  involve patients, clinicians, and health care systems in building a national research resource for conducting meaningful comparative effectiveness research that can inform and improve future care.

As Farzad Mostashari, MD, ScM, the National Coordinator for Health Information Technology, noted, “Right now, we are spending trillions on health care, and 99.999 percent of it doesn’t contribute anything to knowledge.”

The National Patient-Centered Clinical Research Network will encompass a wide group of stakeholders

From the outset, the network we propose will include:

  • patients,
  • researchers,
  • healthcare systems,
  • clinicians, and
  • other stakeholders.

This will make it especially well suited to capitalize on the universe of healthcare information that can be collected, analyzed, and transformed into meaningful discoveries.

New funding announced for research networks

We launched our effort by releasing two new Funding AnnouncementsExternal Links Disclaimer. The funding will go toward creating a series of patient and health systems networks that will eventually link together to become the national network we envision. Required letters of intent are due June 19.

  • We’ll provide up to $56 millionExternal Links Disclaimer to create up to eight clinical data research networks (CDRN), comprised of multiple health systems able to connect and share large amounts of data from de-identified electronic health records (EHR).
  • We will provide up to $12 millionExternal Links Disclaimer to fund the creation of 12-to-18 patient-powered research networks (PPRN), consisting of motivated patients focused on a specific disease or condition and organized to conduct and participate in clinical research.

Once formed, we expect the PPRNs and CDRNs will increasingly work together to establish, test, and refine models for data-driven patient-centered research projects.

Creating a national network presents challenges

We know there are many hurdles to overcome:

  • We must learn how to efficiently obtain reliable and equivalent clinical information from a variety of EHR platforms and healthcare settings, and directly from patients.
  • We will have to collect and store clinical data in ways that allow for aggregation, analyses over multiple sites, and use by external researchers and systems.
  • We also will need to support individual patients in the PPRNs in new approaches to accessing and sharing their personal data. We are particularly interested in the possibilities presented by the Blue Button initiative, which could let patients obtain their clinical data electronically to share it with researchers.
  • We’ll need to pay scrupulous attention to issues of patient privacy and data security.

Patient-Centered Outcomes Research Institute is one of the few research organizations with the resources and capacity to facilitate the creation of a national data infrastructure. We take this responsibility seriously; indeed, improving our nation’s capacity to conduct comparative effectiveness research is one of the reasons we were established.

We want to hear from you

We look forward to watching this initiative grow and evolve with the input, support, and involvement of our entire stakeholder community.

We invite your commentsExternal Links Disclaimer on our vision: watch an archived webcast of the April 23 discussionExternal Links Disclaimer and tell us what you think. Also, consider applyingExternal Links Disclaimer for the funding we’re dedicating to creating an enduring, sustainable national research network that will serve the interests of patients for decades to come.


The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit 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 health care decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work. More information is available at Links Disclaimer.