PCORnet: An Update on Our Blueprint for Transforming Health Research

I just spent a few days attending Health Datapalooza in Washington, DC, the annual gathering of researchers, policymakers, software developers, patients, and others interested in how to use health data to improve care and patient outcomes. And it was clear from the presentations on the stage and the buzz in the hallways that PCORI’s work in this area is generating a lot of attention.

My colleague Rachael Fleurence, PhD, and I, along with PCORI Board of Governors member Harlan Krumholz, MD, were part of two Datapalooza panels on new health data sources for research. It was the ideal platform for bringing the audience up to date on PCORnet, the National Patient-Centered Clinical Research Network we’re developing along with our 29 research network partners.

We’ve invested more than $100 million in PCORnet, an effort to build the infrastructure needed to boost our nation’s capacity to conduct clinical outcomes research that will produce evidence allowing patients and those who care for them make better-informed health and healthcare decisions. When fully in place, we expect PCORnet will be able to harness clinical data from more than 10 million individuals to foster a wide range of studies.

Since development of PCORnet began in late winter, we’ve been busy working on organizational policies and inventorying tools and best practices that might be applicable network-wide. We’ve also developed the first version of a common data model that will create frequently used variables that can be applied in future studies. And we’ve paid particularly close attention to setting up the mechanisms needed to ensure a patient-centered approach to governance—including how health data can be used to advance critically needed research while security and patient privacy are properly safeguarded.

The Nuts and Bolts of Making PCORnet Run Smoothly

We’re doing this important work through a series of task forces and a patient council that will guide PCORnet's activities. We have chartered 11 task forces to address vital aspects of the research process that can accelerate or impede scientific progress, such as ethical and regulatory considerations, clinical trial design, and embedding research into healthcare operations. The task forces will provide a venue for exchanging ideas, sharing expertise, and incubating solutions that can be used across PCORnet.

We are also reviewing nominations for PCORnet's Patient Council, an advisory body that will provide feedback and recommendations on key policies to ensure consideration of the highest patient-engagement standards and of issues related to patient consent and privacy protection.

To change the culture of research, PCORnet will listen to the end users of clinical evidence. Our Patient and Consumer Engagement Task Force, Health Systems Interactions and Sustainability Task Force, and Patient Council will be venues to explore, and understand, perspectives that patients and other stakeholders bring to the research process. This will include perspectives on data privacy and how to ensure research results reach their intended audience.

A Spotlight on Privacy and Security

I’ve mentioned data privacy and security a couple of times, for good reason. It should be no surprise that developing thoughtful and effective policies and processes related to these key issues is one of PCORnet's biggest challenges. We know the stakes are high.

A bedrock feature of this initiative is that patient-level data will remain under the control and stewardship of the individual network that collected it, be it one of our 11 health system-based clinical data research networks (CDRNs) or one of the 18 patient-powered research networks (PPRNs). The data will be secured behind institutional firewalls at all times.

But we plan to go further. With patients and other stakeholders at the table, each CDRN and PPRN will develop its own data-security and privacy-protection policies. This approach will enable each partner network to have the flexibility to conduct research in ways acceptable to its communities. We recognize that the needs of a rare disease network led by motivated and concerned parents (see box), for instance, may require different research policies than a major academic medical center.

Given the complexity of health data privacy, developing these policies will take several months. We are committed to making this process transparent, sharing policies on the PCORnet website as they are ratified by the network.

Spotlight on a Patient-Powered Research Network

Patient-Generated Health Data

One important element of PCORI-funded research is understanding the experiences of individual patients, and one of the ways to learn about those experiences is by collecting patient-generated data. Such information can be obtained in a variety of ways, including during medical visits, through use of smartphones and other electronic devices, and as part of research studies.

Our Patient-Reported Outcomes Task Force is surveying all the partner networks to learn the scope and types of patient-reported data that each currently collects or is considering collecting in the near future. This survey will help guide the development of a common set of data elements that could be collected PCORnet-wide.

The Time Is Now, the Pace Is Fast

The first phase of PCORnet is an 18-month initiative, which is just the blink of an eye in “research time.” We are ambitious in our intention to lay the foundation for efficient, patient-centered clinical research as quickly as we can. We expect there will be a second phase, which will provide ongoing support for the infrastructure established in Phase 1 and initiate pilot studies using that infrastructure. We anticipate that in Phase 2, additional networks will apply to participate in PCORnet.

Learn more on PCORnet's website, and follow us on Twitter @PCORnetwork.

Greene is a Senior Program Officer in PCORI’s CER Methods and Infrastructure program