Trial Will Test PCORnet’s Capacity while Answering Important Patient-Centered Question
For Immediate Release
Patient-Centered Outcomes Research Institute
Washington, D.C. (July 29, 2014) – Assessing whether low- or high-dose aspirin is better for patients with coronary artery disease will be the focus of the first clinical trial to be conducted through PCORnet, the National Patient-Centered Clinical Research Network. The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors approved the trial topic today and up to $10 million to fund the study.
Many of the roughly 15.4 million Americans who have coronary artery disease take aspirin daily as a preventive strategy. More than half of these patients take a higher dose than the 81 milligrams currently recommended by US government guidelines. High doses of aspirin are associated with a greater risk of intestinal bleeding, but there is insufficient evidence to clearly state whether low-dose aspirin is both safer and as effective for patients with this heart condition.
The randomized controlled trial will be conducted by researchers involved in the health data networks that together comprise PCORnet, a national health data research infrastructure being developed with PCORI funding. The trial will serve as a test run of PCORnet’s capabilities and efficiency, in addition to providing evidence to help patients with coronary artery disease and those who care for them make better-informed decisions about an important treatment option.
PCORI invested $93.5 million in December 2013 to support the development and expansion of 29 health data networks—11 Clinical Data Research Networks and 18 Patient-Powered Research Networks—to build PCORnet. The individual networks will collaborate to harness health information gathered from sources such as electronic health records, claims, and patients themselves to power more efficient and faster patient-centered health research.
“We’re pleased that the initial trial to be conducted using PCORnet’s resources will provide valuable information on a fundamental and highly practical aspect of care for millions of people with a common chronic condition,” said PCORI Executive Director Joe Selby, MD, MPH. “Moreover, launching this trial now, in the early stages of PCORnet’s development, will help the network partners assess the interoperability and security of their data and demonstrate the capacity of PCORnet to conduct research more efficiently while maintaining high research standards.”
PCORI will appoint a protocol review committee that will help to develop the trial design and advise the institute during the conduct of the study. PCORI will issue a limited request for proposals in late 2014 to PCORnet partners. PCORI expects to issue funding awards to the team that will conduct the trial in Spring 2015, and the trial is expected to last no more than 18 months.
Aspirin dosage for coronary artery disease was selected from 41 topics initially suggested by network members. The topic was ranked highest among all evaluated by PCORI’s Advisory Panel on Assessment of Prevention, Diagnosis, and Treatment Options, an advisory group whose 21 members represent a broad range of healthcare stakeholders.
More information on PCORnet, its 29 member networks, and its organizational structure and governance can be found at www.PCORnet.org.
The Patient-Centered Outcomes Research Institute (PCORI) is an independent, non-profit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continuously seeking input from a broad range of stakeholders to guide its work.