The PCORI, created as a result of the Patient Protection and Affordable Care Act, grouped the $96 million in awards into four categories, allocating three-quarters of the funds to clinical-care studies and health systems research. Clinical comparative-effectiveness studies will evaluate patient-care methods that have not been adequately studied against alternatives and will not be limited to medical or surgical therapy or exclude self-care, according to the funding announcement.
A category for health systems research, meanwhile, might tackle the effectiveness of such things as medical homes or accountable care organizations, an emerging area of study. “That is a really ripe area where many more patients are beginning to get their care,” said Dr. Joseph Selby, executive director of the PCORI.
In all, up to 109 contracts will be awarded in the four categories, which would produce an average award of about $890,000 if all the contracts and money were doled out. Another round of up to $24 million in awards addressing research that could accelerate patient-centered outcomes research and methodological research is expected to be announced over the summer.
Selby said the applications can be initiated by patients, clinicians or researchers, but the application and research has to include all of them on a team.
The May 23 announcement followed previous approval of 50 pilot project program awards worth $30 million over two years for research designed to help the PCORI build a methodological foundation for its research agenda and program.
The large size of the awards, the requirement that patients be involved and the open nature of the research requested have caught the attention of healthcare researchers. “This is a real 180 from what health services research usually is,” said Jeffrey Lerner, president and CEO of the ECRI Institute. “It's requiring a completely different world view to answer the kind of research they're calling for.”
For a while, some were not sure what kind of research opportunities would come from the institute after it got caught up in the political debate about so-called death panels and objections to comparative-effectiveness studies were raised, but the announcement extinguished those fears.
Early in its life, the PCORI was “a little unclear about what they wanted to do,” and appeared to not want to rock the boat politically speaking, said Dr. Edward Havranek, director of health services research for Denver Health. “I think they wanted to go nowhere near that (comparative-effectiveness) debate.”
But the award announcement requirements show that politics were not getting in the way of their mission, he said. “I think they take this ‘Patient-Centered' part of their name very seriously,” Havranek said. They really want to include the “patient's voice, the patient's needs, the patient's wishes. It's the right thing to do,” he said.
The PCORI's Selby said nothing is off the table in terms of funding clinical comparative-effectiveness research that might face political opposition providing it meets the basic criteria set out by the institute.
“As long as it's a clinical question and a clinical outcome, we're interested,” he said.
Posing perhaps a much greater threat is the 26-state lawsuit opposing the Affordable Care Act that is under consideration by the U.S. Supreme Court. Even a partial strike-down of the law could remove the funding source for this research, Lerner said.
Researchers such as Savitz and Havranek are expected to apply for the funding in droves. “From what I know and people I've talked to, I think there will be a very strong response,” Savitz said.
Similarly, Havranek predicted: “The competition is going to be fierce.”