PCORnet: The National Patient-Centered Clinical Research Network
Patients, their families, and healthcare providers frequently must make crucial healthcare decisions while lacking key information about which preventive, diagnostic, or treatment approach would be best, given a patient’s preferences and circumstances. The Patient-Centered Outcomes Research Institute (PCORI) was created to fund comparative clinical effectiveness research (CER) that will provide needed evidence to help patients and their caregivers make better-informed decisions. However, the nation’s capacity to conduct CER rapidly and efficiently remains extremely limited.
To facilitate more efficient CER that could significantly increase the amount of information available to healthcare decision makers and the speed at which it is generated, PCORI has invested more than $100 million in the development of PCORnet: The National Patient-Centered Clinical Research Network.
PCORnet will be a large, highly representative, national network for conducting clinical outcomes research. PCORnet will foster a range of observational and experimental CER by establishing a resource of clinical data gathered in “real-time” and in “real-world” settings, such as clinics. Data will be collected and stored in standardized, interoperable formats under rigorous security protocols, and data sharing across the network will be accomplished using a variety of methods that ensure confidentiality by preventing patient identification.
- 11 Clinical Data Research Networks (CDRNs), which are system-based networks that originate in healthcare systems, such as hospitals, health plans, or practice-based networks, and securely collect health information during the routine course of patient care;
- 18 Patient-Powered Research Networks (PPRNs), which are networks operated and governed by groups of patients and their partners and are focused on a particular condition and interested in sharing health information and participating in research; and
- A Coordinating Center, led by Harvard Pilgrim Health Care Institute and Duke Clinical Research Institute, which will provide technical and logistical support to the data networks and assist in program evaluation.
A Network to Promote Research Done Differently and More Efficiently
PCORI’s distinct approach to research seeks to involve patients and other stakeholders in all aspects of the research process, from determining which research topics and outcomes should be studied to helping to develop and conduct the studies to sharing the results.
A hallmark of PCORnet is its requirement that the patients, clinicians, and healthcare systems that provide the research data housed in each constituent network be actively involved in the governance and use of the data. PCORnet aims to advance the shift in clinical research from investigator-driven to patient-centered studies.
PCORnet will establish a functional research network that is nationally representative of health information and will significantly reduce the amount of time and effort required to start studies and build the necessary infrastructure to conduct them. It will support a range of study designs, including large, simple clinical trials and studies that combine an experimental component, such as a randomized trial, with a complementary observational component.
Because PCORnet will enable studies to be conducted using “real-time” data drawn from “real-world” settings, it should increase the relevance of the kinds of questions that can be studied and the usefulness of the study results.
Phase I: Building PCORnet
During an 18-month development phase, PCORI is working with the PPRNs, CDRNs, Coordinating Center, and other stakeholders to refine the capabilities and capacity of the individual constituent networks. Through the work of the Coordinating Center Task Forces and a steering committee, PCORnet will develop policies governing data sharing, security. and protection of patient privacy across the overarching network. By the end of this phase, PCORI expects a functional research network to be in place and ready to support CER studies.
Functioning as an advisory group to PCORI leadership, the PCORnet Steering Committee will review proposed policies and recommendations from the Coordinating Center Task Forces. Collectively, the policies, operations, and products of the Steering Committee and Task Forces will support the development of a robust infrastructure for the efficient conduct of patient-centered clinical research. In addition, the Steering Committee will play an important role in exploring uses of the network by all funders of research.
The Steering Committee will include representatives from each CDRN and PPRN, the Coordinating Center, and federal and private sector funders of research and providers of clinical data. The Task Forces will focus on developing PCORnet policies, procedures, and infrastructure.
Phase II: Planning Under Way
Planning is under way for Phase II of PCORnet, and we expect to release a funding announcement in winter 2014 for an anticipated start in fall 2015. It will be open to Phase I networks and new applicants. All applications will be rigorously vetted through a competitive review process.
While the basic network structure funded under Phase I will continue in Phase II—clinical data research networks (CDRNs) and patient-powered research networks (PPRNs), supported by a coordinating center—the total amount of available funding will likely be lower than the current Phase I investment.
To inform the development of the Phase II PCORI Funding Announcement (PFA), PCORI is also issuing a Request for Information (RFI) to obtain information on the potential cost of ensuring continuity and sustainability of the network. While this RFI is open to all, PCORI is particularly interested in responses from individuals who have knowledge of and experience working with existing large regional or national research networks, especially networks oriented to patient-centered comparative effectiveness research. Responses to this RFI will inform and develop a Phase II PCORnet Business Case that delineates the range of costs required to sustain CDRNs and PPRNs during Phase II.
Phase II funding will support the structure, governance, communications, and logistics of the networks, which will ensure cohesion and ongoing functionality. In addition to supporting these general activities, Phase II funding from PCORI will be devoted to developing and maintaining data resources, conducting “prep-to-research” activities, and building the capacity of newly funded networks. In response to emerging research opportunities, it will likely be necessary during Phase II to develop new areas of research capacities, including expansion of the PCORnet Common Data Model.
Phase II funds may also be used to develop new areas of research capabilities in response to emerging research opportunities. To be successful, recipients of Phase II funding must be capable of conducting individual and joint research projects and must also demonstrate the capability to supplement PCORI infrastructure funding with direct research funds. Future studies conducted through PCORnet may include large retrospective and prospective observational studies as well as prospective individual and cluster-randomized comparative effectiveness trials. Additional funds may also be set aside to support competitive funding of infrastructure pilots or PCORnet-directed pilot funding, contingent on approval by PCORI’s Board of Governors.
In coming years, while PCORI will continue to provide funding to support this infrastructure initiative, this support will decrease with the expectation that it will be augmented by funding from other agencies such as the National Institutes of Health, the Food and Drug Administration, and others. Seeded by PCORI’s initial investment, we envision a long lifespan for PCORnet.
Posted December 16, 2013; Updated June 16, 2014