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. PCORI was established 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 is a large, highly representative, national network for conducting CER. It fosters 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 is collected and stored in standardized, interoperable formats under rigorous security protocols, and data sharing across the network uses 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
- 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 involves 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 is establishing a functional research network of health information that is nationally representative and will significantly reduce the 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 enables studies to be conducted using real-time data drawn from real-world settings, it should increase the relevance 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 is developing 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 reviews proposed policies and recommendations from the Coordinating Center Task Forces. Collectively, the policies, operations, and products of the Steering Committee and Task Forces support the development of a robust infrastructure for the efficient conduct of patient-centered clinical research. In addition, the Steering Committee plays an important role in exploring uses of the network by all funders of research.
The Steering Committee includes 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 provide venues for networks to share experiences and best practices in a given topic area, such as patient and consumer engagement.
Phase II: Sustaining the Network
Phase II of PCORnet will begin in fall 2015. The basic network structure funded under Phase I—clinical data research networks (CDRNs) and patient-powered research networks (PPRNs), supported by a coordinating center—will continue in Phase II. Phase I networks and new applicants may apply as CDRNs and PPRNs for this funding.
Funding from PCORI will support general activities of the networks, including structure, governance, communications, and logistics. In addition, Phase II funding will be devoted to building the capacity of any newly funded networks, developing and maintaining data resources, and conducting “prep-to-research” activities. In response to emerging research opportunities, PCORnet during Phase II will develop new areas of research capacities, including expansion of the PCORnet Common Data Model.
Recipients of Phase II funding are expected to conduct individual and joint research projects and supplement PCORI infrastructure funding with other 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.
In coming years, PCORI’s support for this infrastructure initiative will decrease with the expectation of funding from other agencies, such as the National Institutes of Health and the Food and Drug Administration. Seeded by PCORI’s initial investment, we envision a long lifespan for PCORnet.
Posted: December 16, 2013; Updated: January 7, 2015