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.
Posted December 16, 2013; Updated December 28, 2013