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PCORnet: The National Patient-Centered Clinical Research Network

01/29/2014

"This platform could change the way research is done in the future … We all need to work together to make this a success,” concluded COPD Foundation Founder and President John Walsh near the end of FasterCures’ Jan. 29 Webinar about the new $100 million PCORnet (National Patient-Centered Clinical Research Network) initiative of the Patient-Centered Outcomes Research Institute (PCORI).

Walsh represented one of the 18 Patient-Powered Research Networks (PPRNs) awarded PCORI funding. His comments followed a presentation by Joe V. Selby, executive director of PCORI, and Susan Sheridan, PCORI’s director of patient engagement, about the vision for this ambitious new resource and its importance for post-market comparative effectiveness research (CER) but also for upstream therapy development.

As Selby described it, the goal of PCORnet is to improve the nation’s capacity to conduct comparative clinical effectiveness research more efficiently, by creating a large, highly representative, national patient-centered clinical research network with a focus on conducting CER, both randomized and observational. The vision is to support a learning U.S. healthcare system, which would allow for large-scale research to be conducted with enhanced accuracy and efficiency within real-world care delivery systems. With this “network of networks” – bringing together interoperable electronic health records, claims, and patient-reported data on millions of individuals – in place, he was confident that “we can make R&D cost less and go faster.”

Key to the success of PCORnet will be use of the infrastructure for a range of research activities supported by PCORI and other sponsors. “We’re very interested in the sustainability and use of this network. We’d like to be co-funding outcomes research with other funders, whether NIH or patient foundations. This is a resource that others can use,” Selby emphasized.

The building blocks of the network are the 11 Clinical Data Research Networks (CDRNs) and 18 PPRNs that were approved for funding by PCORI’s Board of Governors in December. Selby explained that the CDRNs – which are primarily networks of academic medical centers, hospitals, and physician practices – are expected to compile complete, longitudinal data on a minimum of one million patients within 18 months. Each individual network’s data must be in an interoperable format with other awardee networks and successfully respond to queries. And each CDRN must identify, characterize, and survey at least three patient cohorts – one in obesity, one in a common condition, and one in a rare condition.

The PPRNs represent groups of activated individuals willing to provide their own patient-reported data for comparative effectiveness research. They must represent at least 0.5 percent of the U.S. population with a condition and collect patient-reported data for at least 80 percent of the cohort. The COPD Foundation’s Walsh said the “opportunity to share common data elements” and create a “uniform process to collect and analyze data and recruit for clinical studies” is significant, and that “we need a community-wide effort to keep it successful.”

The inclusion of PPRNs and PCORI’s overall emphasis on meaningful patient engagement are unique in this kind of large-scale research enterprise. Patients will be engaged in all aspects of the development of PCORnet, including enrollment and diversity, governance, data collection (including development of patient-reported outcomes measures), and data sharing and privacy. For Selby, patient engagement is not a box to be checked, but is rather a key ingredient for getting to relevant, useful research. Engagement also “drives dissemination and adoption; it improves practice,” he said.

Achieving a single functional research network – “a national sandbox,” as Selby referred to it – capable of facilitating efficient, large-scale interventional and observational research is no mean feat. In addition to the technical and policy hurdles, challenges will include facilitating the trust that leads to collaboration between networks and engaging individuals and organizations beyond the initial awardees. But improving the nation’s capacity to conduct CER and pre-market clinical research rapidly and efficiently, and providing needed evidence to help patients and their caregivers make better informed decisions have become a national imperative. The time has come to take on the challenge.