Date: December 15, 2015
Authors: Joe Selby, MD, MPH; Rachael Fleurence, PhD; Adrian Hernandez, MD, MPH; Peter Margolis, MD, PhD; Richard Platt, MD, MSc; Sharon Terry, MA
Two years ago, PCORI began an ambitious journey to find a faster, less expensive, more powerful way to conduct comparative clinical effectiveness research (CER). That’s when our Board of Governors approved an initial $100 million investment in PCORnet, the National Patient-Centered Clinical Research Network. The goal: work with patients, researchers, clinicians, and health systems leaders to build and run a network using standardized electronic health record information, from multiple delivery systems covering tens of millions of patients, to conduct research addressing the real-world needs of patients and those who care for them.
Today, we look back on the recently completed 18-month first phase of this unprecedented initiative pleased by the progress we’ve made, aware of the challenges we’ve faced, and ready to build on our successes as we strive toward research readiness, network growth, and sustainability during the second phase of PCORnet’s development.
PCORnet grew out of the growing recognition within the healthcare community that our current clinical research system, for all of the great advances it produces, is badly in need of improvement. There are lots of reasons why.
Research—especially large clinical trials—is currently very expensive, very slow in both the setup and conduct of the study. Often, completed studies are not large enough or designed properly to answer the questions most critical to patients. They don’t involve patients who are representative of important population groups. Or they don’t yield results that will apply well in typical healthcare settings. And many simply fail to answer the practical questions that patients and clinicians face every day.
PCORnet is intended to address these issues by creating a “network of networks” that harnesses the power of large amounts of health information and unique partnerships among patients, clinicians, health systems, and others. In the process, it seeks to transform the culture of research from one directed by researchers to one driven by the needs of patients and other healthcare stakeholders.
Phase I Highlights
PCORnet began as a collection of 29 individual networks—11 Clinical Data Research Networks (CDRNs), based in large healthcare systems, and 18 Patient-Powered Research Networks (PPRNs), based in organizations led by patients and caregivers—plus a Coordinating Center providing logistical assistance.
Their task was to build the infrastructure for a secure national resource of standardized, complete clinical data that could be used by research teams to efficiently conduct important patient-centered research. In the process, the partner networks also had to figure out how to create processes that would make sure patients and other key stakeholders play a central and meaningful role in how PCORnet is organized and run.
We’re pleased to say that PCORnet and its partner networks succeeded in building out PCORnet’s basic structure, creating models for engaging patients and other stakeholders in their work, laying a foundation for making their health data “research ready” while protecting privacy and security, building unique and productive partnerships, and launching a series of demonstration studies. You can read more about these achievements here.
In July, PCORI’s Board approved a second investment of $142 million for PCORnet’s three-year second phase of development. These awards will fund the 13 CDRNs and 20 PPRNs that will finish building the network to the point where researchers from both within and outside PCORnet will be able to tap into its capacity to conduct a range of important studies.
Related goals include ongoing refinement of the processes needed to run PCORnet effectively and transform it into an independent network that takes full advantage of the unique partnerships and collaborations formed during Phase I. The work includes network efforts to develop and share new research tools, expand the standardized data resources, develop joint research proposals, respond to a range of queries from others with research ideas and funding, and conduct efficient clinical trials and large observational studies. PCORnet will attract research funding from multiple sources and share the research resources developed with the research community. You can read more about our Phase II goals here.
Facilitating progress toward meeting these new goals will be a new PCORnet governance structure, one that puts more day-to-day decision-making authority into the hands of CDRN and PPRN representatives rather than the Coordinating Center or PCORI staff. This new approach grew out of a commitment by PCORI and PCORnet leadership to apply the lessons learned as the network developed to making it work more effectively. You can find out more here.
From Concept to Reality
In a very short time, PCORnet has grown from a theory of how to improve patient-centered outcomes research and CER to a maturing enterprise that will provide a powerful national resource for faster, more efficient, and more patient-centered studies.
Already, PCORnet has led to the growth and expansion of many innovative research networks that have pioneered collaborations among clinical scientists, healthcare delivery systems, and patient organizations, which illustrate the network’s potential. The demonstration studies now under way will, we believe, further establish PCORnet’s capabilities and efficiencies.
We are confident that the national research community and research funders will see PCORnet as a vital resource worth using and investing in. More importantly, we believe the culture and practices PCORnet is building can offer a model of research integrated into care delivery and communities that others will adopt, leading to more efficient studies and more useful results from our national investments in improving health and health care.