NIH is piloting clinical research in primary care with a $30 million program

FFor many Americans, health care means going to a local primary care office. But the vast majority of clinical research is conducted within the walls of large, specialized academic health centers. Millions of patients are excluded from these studies, which often fail to capture the population in all its diversity.

Now, for the first time, the National Institutes of Health is investing in the creation of a national primary care research network to address this problem. The $30 million pilot program is called Communities promote research equity for health and announced Thursday, will fund and support a small number of primary care centers as they participate in a series of clinical trials.

“This is an incredibly exciting opportunity,” said Diane Harper, a family physician and professor of family medicine at the University of Michigan, Ann Arbor. Rather than conducting individual, isolated research projects from specialized locations, the program will enable network members to participate in a variety of studies – choosing between 20 and 30 studies – to meet the health needs of their local population.

“A person is not a disease, and most of the NIH is organized around diseases,” Harper said. “This is the first time NIH has recognized that people are complex and that there are many factors related to their health care… that cannot be separated and separated to be studied in one specific line.”

The pilot is an opportunity to better understand how research can meet the needs of patients outside the traditional setting, said NIH Director Monica Bertagnolli. “We know that every community is different, and we can’t just assume that a rural community in Alabama will be the same as a rural community in Montana or that their health issues will be the same,” she said. “What we want to do is be able to offer each community a whole range of different research opportunities, learning through experience what they find most meaningful.

The research projects will go beyond drug trials and emphasize issues acutely experienced by communities experiencing health disparities, including substance abuse, mental health disorders and obesity.

The timeline is tight: NIH hopes to award funding very soon and hold its first investigator meeting by winter. The focus on a quick start, Harper says, doesn’t give primary care centers enough time to apply for the funding deadline set for next week. As a result, she fears the first round of research will be led by academic networks with ties to primary care. “These are not primary care networks,” she said. “These are PhD students with ideas about what it means to work in primary care, they are not the people who practice.”

The accelerated timeline was put in place to support a launch by the end of fiscal year 2024, NIH spokesperson Renate Myles said, while still leaving the application period open for about six weeks. “We expect more opportunities in the coming years for potential applicants who were unable to participate this year,” she said.

This is not the first experiment with research networks in primary care. “There are many people who have worked for a long time to help the NIH get to the point where they are ready to take their research out of the academic medical center and into rural, borderline and underserved community practices,” said Jack Westfall, a rural family physician and retired professor at the University of Colorado.

In the late 1990s, Westfall helped found the High Plains Research Network, a survey network of all primary care practices in Colorado’s eastern, rural, and borderlands cities—most with only a few thousand residents each. He has discovered that community studies can also pay off for researchers.

“NIH research needs to move beyond academic medical centers, into the community, into primary care practices, both to find subjects, but also to find research ideas,” Westfall said. “Often there are clinical questions that emerge from the community, from the patients, from their interactions with their physicians, that can generate ongoing ideas for research.”

The NIH also sees the program as an opportunity to gain trust from communities skeptical of the medical establishment. “We are here to understand what people need and earn their trust by delivering for them,” said Bertagnolli. “Trust is not automatic, it must be earned.”

To build that trust, the network will have to be careful not to treat patients and their local healthcare providers like cogs in a machine. “The risk is that this will only be extractive, not collaborative,” says Westfall. “We want to make sure that this is not just an extraction of subjects from primary care and the NIH, but a bidirectional flow of resources, of ideas, of subjects, of power.”

“Making studies available closer to where people are actually being treated is the first step,” said Andrew Trister, chief medical and scientific officer at Verily, an Alphabet company that builds clinical research tools. But it raises some important questions, he said: “What is the chain of trust? Who is trusted in the community? Who could help people understand more about what the clinical trial is about? Why participate in research?”

In the future, the network could help primary care centers mobilize more effectively in the event of national health emergencies. “Primary care was not used efficiently at all during the Covid pandemic,” Harper said. But if the pilot is successful and expands to create a nationwide network, it could ultimately enable a faster, more effective public health response — and clinical trials to boot.