Comparative effectiveness research (CER) studies aim to determine what works (and what doesn’t) in the real world of clinical medicine. Such studies are essential to identify the safest, most effective ways of detecting, treating, and preventing disease. Yet, both patients and researchers are often frustrated by the agonizingly slow pace at which many CER studies proceed. Under our current system, it’s often a long, costly process to identify trial sites, recruit volunteers, run the study, compile data, and, finally, analyze the results. The time is ripe to revamp the way we do this.
Rather than starting from scratch for each CER trial, it would be far more efficient if researchers could tap into networks that include millions of patients—of all ages, ethnicities, and socioeconomic strata—who have agreed to participate in research. If these patients all have electronic medical records, that’s even better, making it possible to extract data quickly for a particular observational or interventional trial. That way, just by visiting their regular health care providers, many more patients would have the opportunity to become active participants in medical research with the potential to improve not only their own health, but the health of all Americans.
A large network of this sort has been an elusive goal in the United States. But thanks to the Patient-Centered Outcomes Research Institute (PCORI), on whose Board of Governors I serve, our nation has just taken a major step towards realizing this new vision. PCORI, which is authorized by Congress to conduct research aimed at helping patients and health care providers make more informed decisions, today announced the launch of a highly innovative, data-sharing network, called the National Patient-Centered Clinical Research Network, also known as PCORnet.
This initiative will provide an unprecedented opportunity to streamline clinical trials, empower patients, and build a solid foundation for personalized medicine. Let me explain how.
PCORnet will be made up of two types of data networks: Clinical Data Research Networks (CDRNs) and Patient-Powered Research Networks (PPRNs). CDRNs include academic health centers, community hospitals, health plans, inpatient and outpatient hospitals and providers, Veterans’ Administration clinics, pediatric hospitals and providers, private electronic health record companies, and many other health care groups. Utilizing electronic medical records, all of these organizations will build patient databases and a clinical trial infrastructure that can be accessed by researchers from many different organizations (including NIH), while protecting patient privacy and confidentiality.
As the name suggests, PPRNs are patient-oriented groups united by a certain disease or condition. The successful groups receive support from PCORnet, and are charged with outreach, expanding networks of patients, and collecting standard patient data—all of which are critical for researchers looking to recruit volunteers for a clinical trial.
To build PCORnet, PCORI solicited applications earlier this year and subjected them to rigorous peer review. Today, the results of that review process are being announced. PCORI will distribute $93.5 million among 29 awardees: 11 CDRNs and 18 PPRNs. Of the PPRNs, nine represent common conditions, such as cardiovascular disease, and nine represent rare conditions, such as muscular dystrophy.
These groups will use the funds to conduct pilot projects aimed at creating, enabling, and testing common data models over the next 18 months. A previously funded coordinating center will oversee this complex start-up. If all these efforts prove successful, the network has the potential to expand to more than 100 million people all across the United States.
NIH is thrilled that these organizations have come together and agreed to create a single, overarching network that will be seamlessly integrated using electronic databases. But the real excitement will come once we see this network in action: helping to speed efforts by clinical researchers to test the treatments and cures that so many people urgently need.
Network news: powering clinical research. Selby JV, Krumholz HM, Kuntz RE, Collins FS. Sci Transl Med. 2013 Apr 24;5(182):182fs13.