Robert Califf—FDA commissioner for 11 months before the new administration came in this year, and now back at Duke University—has launched a new nonprofit clinical research network that aims to place people at its core rather than other more traditional drivers of the drug development industry.
In a move not seen before by any research groups, said Califf, the new People-Centered Research Foundation (PCRF) will have a board that’s at least 20% occupied by patients, study participants, patient advocates and/or patient caregivers who will help direct research questions, protocol design and implementation.
“People will be involved in leadership roles in all committees, and will have the opportunity to be involved in the development and execution of the research,” said Califf, who, before joining the FDA in 2016, was vice chancellor of Clinical and Translational Research at Duke University, director of the Duke Translational Medicine Institute, a professor at Duke University School of Medicine and the cofounder of the Duke Clinical Research Institute. He’s now the chair of PCRF’s board.
In addition to people in the patient community, PCRF will partner with other more traditional stakeholders—clinicians, health systems leaders, representatives from the life sciences industry, clinician professional organizations and the government (NIH, FDA, etc.) to design and conduct research, added Califf.
But patients will be the star of the endeavor, said those behind the effort.
“Not to take anything away from science for science’s sake, but when patients are able to offer significant input to the process, they are very practical, which is something, as an industry, we need,” said Donna Cryer, president and CEO of the Global Liver Institute and now a PCRF board member. Cryer has also been a patient for many years due to chronic conditions. “I think the patient perspective can bring a granularity, some imagination and new excitement to the process.”
So will patient advocacy groups, which traditionally have worked in silos, added Cryer.
“Part of the power will be in having so many patient advocacy organizations with all of their members and volunteers,” she said. “We’re sort of knotting together what had been very disparate, non-strategic, one-off approaches to research projects and bringing them into a cohesive, pervasive national drumbeat about participation in research.”
People-centricity is all part of a bigger trend that shifts the focus of the research endeavor to patients—what’s ailing them, what would help them, what they’d like to see come out of research and how they’d like to be treated all the while, said Califf.
“It’s part of a bigger societal trend we’re seeing,” he said. “More people are now activists about their healthcare, and we’ve seen their involvement work to speed up trials in, for example, breast cancer and multiple myeloma.”
The new foundation will provide retrospective observational research using its data network, prospective research that collects new data from patients and clinical trials, said Califf.
PCRF builds on the existing National Patient-Centered Clinical Research Network (PCORnet) at Duke, which includes 33 research networks that collaborate to conduct patient-centered research. PCORnet was launched with an investment from the Patient-Centered Outcomes Research Institute (PCORI), which was founded in 2014, and has since begun more than 20 studies and has approximately 70 publications in scientific journals.
Califf said one of PCRF’s chief goals is to do research in a less costly way, relying heavily on electronic medical records (EMRs). He pointed to recent examples from PCORI. The group is now involved in an observational study looking back at weight loss using bariatric surgery and other approaches, weighing the risks and benefits of each using data spanning recent decades. They’re also using EMRs to look closely at the dosing of aspirin to prevent coronary disease.
“We’ve been doing that for 50 years, so you’d think we’d have the dosing right, but we don’t,” said Califf. “We hope to get to the bottom of that.”
PCRF research will be sponsored by a mix of support from government, foundations and industry, Califf said. All projects will be aligned with the foundation’s mission of centering projects on the needs of people and their health.
The hope is that PCRF can help move the needle in recruitment, too.
“One of the problems that has been part of the imbedded architecture of clinical research from the beginning was that a person was rarely presented with a clinical trial—or they’re not presented with the option of a trial until they’re very sick,” said Cryer. “This new foundation plans to unlock that door for participants. It’s about having patients ready and willing to participate in a future of research, and it’s about changing the culture—starting with calling them ‘participants’ instead of ‘subjects.’”
Califf said he hopes the nascent organization will eventually create a “new wave” across the industry of companies and organizations using meaningful patient involvement to inform research. The long-term hope? That the model will take a deep hold, resulting in accelerated research in all disease areas.
This article was reprinted from Volume 21, Issue 13, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »