While the U.S. spends a significant amount of time and money on clinical research, many of the questions that patients, their families, and clinicians ask about healthcare — specifically questions about which options are best for individual circumstances and goals — cannot be easily answered. The current clinical research system faces several problems: it’s too expensive, it takes a long time to get results, and it doesn’t answer practical questions that patients want answers to.
In 2014, the Patient Centered Outcomes Research Institute (PCORI) invested more than $250 million in the development of PCORnet: The National Patient-Centered Clinical Research Network, designed to empower people to make informed healthcare decisions by enabling clinical research that is faster, easier, less costly and, most importantly — more relevant to their needs.
PCORnet is a large, highly representative, national “network of networks” that collects data routinely gathered in a variety of healthcare settings, including hospitals, doctors’ offices, and community clinics. By engaging a variety of stakeholders – patients, families, providers, and researchers – PCORnet empowers individuals and organizations to use this data to answer practical questions that help patients, clinicians, and other stakeholders make informed healthcare decisions.
A hallmark of PCORnet is that the patients, clinicians, and healthcare system leaders are all 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.
The mission of PCORnet is to enable people to make informed healthcare decisions by efficiently conducting clinical research relevant to their needs.
Who is Involved?
PCORnet is comprised of a Coordinating Center and 33 Partner Networks, including 13 Clinical Data Research Networks and 20 People-Powered Research Networks.
Clinical Data Research Networks (CDRNs) 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. Patient-Powered Research Networks (PPRNs) are networks operated and governed by groups of patients and their partners, including caregivers, clinicians, researchers, and others. They are focused on a particular condition or population, and their members are interested in sharing health information and participating in research. An extension of PCORI’s Patient Engagement philosophy remains an integral part of CDRN and PPRN Partner Networks. PCORnet empowers patients, caregivers and other stakeholders to become engaged in the research process from start to finish – including the design, conduct, analysis, and dissemination of research results
The PCORnet Coordinating Center, led by the Duke Clinical Research Institute, Genetic Alliance, and Harvard Pilgrim Health Care Institute provides technical and logistical support to all of the CDRN and PPRN networks.
How Does It Work?
PCORnet uses a Distributed Research Network (DRN). In a DRN, each Partner Network securely collects and stores data in a standardized way within their own institutions. When a researcher or user (called a Requestor) submits a research question through an online access point called the “Front Door,” that question is reviewed by the Coordinating Center. The Coordinating Center then taps the data of the individual Partner Networks through a specialized query format. A response to the original question is generated, and sent back to the researcher. Through this structure, PCORnet allows researchers to ask the same question of millions of people across the country all at the same time.
The goal of PCORnet is to significantly reduce the time and effort required to start studies and build the necessary research infrastructure to conduct them. PCORnet 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.
How Does PCORnet Ensure the Security of Patient Data?
PCORnet’s Distributed Research Network uses four layered techniques that maximize the security of personal information.
- The Network uses a Common Data Model that does not include any real patient/member/participant or provider identifiers. Instead, each site within a network contributing data creates a pseudo-identifier for each patient and provider. This pseudo-identifier is not traceable to a specific individual without a separate cross-walk table that each site stores separately from the data and is not part of the Common Data Model.
- Each Partner Network uses a distributed database. Because each site contributing data holds its own data, a single data breach cannot expose the entire Network’s data.
- PCORnet encrypts data during transmission.
- The PCORnet Coordinating Center stores transferred data in a Federal Information Security Management Act (FISMA) compliant tier III data center.
How Does PCORnet Ensure the Data are Used Appropriately?
PCORnet’s governance structure provides oversight to ensure that the Network’s resources are used efficiently and appropriately. There is a multi-stakeholder Executive Committee that oversees the operations of the PCORnet, as well as Data, Research, and Engagement Committees that address cross-network issues such as research ethics, privacy, patient involvement, and clinical trial designs and methods.