The Patient-Centered Outcomes Research Institute (PCORI) announced on April 23 that it is offering $68 million in funding opportunities to entities to develop a national patient-centered clinical research network.

PCORI unveiled the large-scale comparative effectiveness research initiative at a roundtable discussion event at the National Press Club in Washington, DC, which brought together government, industry and patient advocacy representatives—including Farzad Mostashari, MD, ScM, national coordinator for health IT.

PCORI Executive Director Joe Selby, MD, MPH, said it will fund up to $56 million to support a maximum of eight Clinical Data Research Networks (CDRNs) and $12 million to fund up to 18 new and existing Patient-Powered Research Networks (PPRNs) for 18-month pilot projects. The CDRNs will develop the capacity to conduct randomized comparative effectiveness studies using clinical practice data in specific populations, and the PPRNS will work to develop a reusable, scalable and sustainable research network, he said.

“Many people see the vision of data being harnessed to support meaningful research,” said Selby at the roundtable discussion. He described four components of the national network:

• Separate networks that link together to form one national infrastructure
• Development of two types of component networks: systems-generated and a patient-driven network (healthcare system must be involved)
• Active involvement of healthcare systems, clinicians and patients
• Commitment of funded entities to establish interoperability and data sharing across networks and ready collaboration with the larger research community

A coordinating center will facilitate the whole effort, and be led by a steering committee with industry, government and patient advocacy organization representatives, Selby said at the event.

The diverse support for a national clinical research network was reflected in the panel members at the roundtable.

In that discussion, Mostashari said a national network would turn every healthcare encounter into one that both benefits from the world’s knowledge and contributes to it. “We take healthcare that is happening in the real world, and patient experiences in the real world, and have that contribute to knowledge,” he said.

Mostashari said the second stage of Meaningful Use (MU) incorporates standards for packaging information for transmission. “Folks should not try to go out and discover their own standards, but use standards available in [MU] to help create a national network built towards greater interoperable research,” he said. The requirement for patients to view, download and transmit their healthcare data to share with their providers or contribute to research “will help us push the interoperability picture.”

“Much medical care isn’t evidence based. It’s too expensive and logistically impossible to gather evidence,” weighed in Janet Woodcock, MD, director of the FDA Center for Drug Evaluation and Research, at the roundtable. She said the nationwide network will jumpstart efforts for one national source of actionable data, but said developing the methodological rigor to ensure data are reliable will take time.

“We have another mile to go before we get what we need out of this,” she said, stressing that another major challenge is creating “an infrastructure of experts” in privacy and analysis to manage this research.

While supporting the PCORI initiative, John Castellani, president and CEO, Pharmaceutical Research and Manufacturers of America, reiterated that concern. “I caution that there is a lot of noise in databases, and it can be very difficult to separate that noise from true signals that can advance the science.”

However, he said the pharmaceutical industry spends $50 billion per year on research and development of new drugs, with half of that spent on clinical trials, thus a national infrastructure holds “great promise” in advancing scientific research on drugs and their outcomes.  

Ann Bonham, PhD, chief scientific officer at the Association of American Medical Colleges, expressed gratitude for PCORI taking on the initiative.

“We see it as an unprecedented format and evidence base to allow for rapid-cycle feedback to physicians and patients,” she said, adding that tapping into these data can help reduce healthcare disparity gaps in vulnerable populations. She said as residents and medical students begin working in an environment where EHR data are shared, “this becomes the norm. For us, this is a long time coming.”

In her comments, Ardis Dee Hoven, MD, president-elect, of the American Medical Association, said a national infrastructure is a great opportunity to coordinate with clinical registries, which already measure patient outcomes and support quality improvement networks. She said patients with heart disease, stroke and diabetes stand to benefit from PCORI’s patient-centered national clinical research network.

Barbara Lardy, senior vice president, clinical affairs and strategic partnerships, America’s Health Insurance Plans, expressed enthusiasm for the initiative. “Health plans certainly want to be at the table and involved going forward.”

During the discussion, attendees also stressed the challenge of building trust in patients that their data are secure and protected.

To view PCORI’s funding announcements, go here. Mandatory letters of intent from applicants are due June 19 and applications are due Sep. 27.