The Affordable Care Act generated more than the health exchanges and our favorite Sunshine Act. The law also created the Patient-Centered Outcomes Research Institute (PCORI), tasked with launching and coordinating comparative clinical effectiveness research (CER) – to find out which drugs, devices, and treatment options are more effective than others. PCORI recently began an 18-month project which aims to link together a network of millions of patients' medical records. Researchers could glean valuable information on comparative effectiveness from the data.
PCORI's vision, entitled PCORnet: The National Patient Centered Clinical Research Network, involves a "large, highly representative, national network for conducting clinical outcomes research." Importantly, the network would "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."
The Washington Post recently highlighted the progress PCORI has made, along with the challenges ahead. The Post notes that "government-funded scientists have begun collecting and connecting together terabytes of patient medical records in what may be one of the most radical projects in health care ever attempted." The researchers are collecting information on patients' diagnoses and conditions, results of blood tests, X-rays, MRI scans, as well as information on surgeries, insurance claims, and even links to genetic samples. "Nothing of this scale has been built before," the Post reports, "and researchers say the potential of the network to speed up research efforts and to answer questions that have long vexed scientists cannot be overstated."
Currently, clinical studies are very narrow in focus. "Physicians have long grumbled that few studies can be translated into practical advice," states the Post. "Some studies are too small to draw any definitive conclusions. Others include patients diagnosed with a single condition, while most patients are more complicated — they suffer from multiple issues. It isn't uncommon for studies to contradict each other, and there's no way for clinicians to know which one is right, because they often use different methodologies."
The Post also interviewed Francis S. Collins, director of the National Institutes of Health (NIH), who noted that time consuming nature of the randomized trials the NIH typically supports. "[Y]ou have to enroll patients from the very beginning, and that's a big infrastructure-building process that can take quite some time. And once a trial has been conducted, the whole thing has to be taken down again," Collins said. "It's a great way to answer one specific question, but it's not an efficient way to ask lots of questions."
On April 17, shortly after the Washington Post article, Joe Selby, Executive Director of PCORI, provided an update on PCORnet:
"[V[ast amounts of valuable health information are created every day during patients' interactions with clinicians, healthcare systems, and one another. The data generated through these real-world patient experiences are really the best way to find out what works best for patients in typical clinical care, given their individual circumstances and needs.
Opportunities to use this kind of health information are often missed, however. Most patients receive their care in more than one system. What's more, the individual systems have lacked efficient ways to communicate or collaborate with each other; this impedes comprehensive follow-up as well as research. Finally, single systems usually can't conduct studies that are large enough to provide reliable answers about what works for individual patients.
PCORnet is designed to address these issues. By integrating 18 Patient-Powered Research Networks and 11 health system–based Clinical Data Research Networks, it will facilitate the use of both patient-provided information and clinically derived data to support research. By folding research activities into clinical practice without interrupting the flow of care, PCORnet aims to facilitate comparative clinical effectiveness research and other kinds of studies on topics and questions most relevant to the needs of patients and those who care for them. The result will be a system that will enable researchers to ask clinical questions and derive results quickly and efficiently."
As Selby noted, 29 health data networks across the country are going in on the effort, 11 clinical data research networks and 18 patient powered research networks. View the lists here.
Anyone who has spent time in healthcare policy knows that a network of medical data covering millions of American patients raises some issues. Namely, critics have voiced concerns over patient privacy, questions of who would own and control the data, and how research would be prioritized.
According to PCORI's website, "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."
Selby also addressed this challenge.
"Of course, it will take significant work to connect PCORnet's 29 individual health data networks, with coverage spanning the entire country, and develop the structures, governance, and policies to ensure that the national network they form operates smoothly and securely," he notes. "But building and leveraging the power of a large clinical data network and ensuring the security and privacy of sensitive personal information aren't mutually exclusive."
Selby states that "the need to provide robust data security measures and policies and procedures to guard patient privacy" is PCORI's chief concern. The 29 partner networks "will have their own governance systems and maintain their own data, which will be securely protected by a firewall. Each partner network will develop security measures, policies, and procedures that are right for its members, as we develop general policies that will apply to PCORnet as a whole. A critical feature of this effort is that patients will be deeply involved in creating these policies."
The privacy aspect of the database is a work in progress. "As we develop overall governance policies for PCORnet and create the structures, methods, and means that will allow networks to operate together, we'll provide specific information on how research teams can access the data and how queries will be handled, prioritized, and answered," says Selby. "We expect patient data provided in response to research requests will be stripped of personal identifying information, which will not leave the health system or original network, unless patients have explicitly consented to its release for a particular research purpose" (emphasis added).
In conclusion, Selvin stated: "During the 18-month development phase, which ends September 2015, we will work continuously to improve the quality of the data and the efficiency of the PCORnet's capacity to support research." He believes "each individual network will benefit from comparing approaches, and the most successful procedures and policies will be shared and refined." Finally, he predicted "that PCORnet will be a true game-changer in health research."
The Post also noted a number of questions, including: "How will research questions be prioritized? How should disagreements be resolved? Should pharmaceutical companies and insurers be able to access the records and, if so, under what circumstances? What about the Centers for Disease Control and Prevention? The information could help epidemiologists track outbreaks and clusters of disease in a way they have never done before."
Also, "critically important to the multibillion-dollar pharmaceutical industry, how will the Food and Drug Administration view this type of research when considering applications for new drugs or in recalling old ones?"