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“It’s in our DNA,” Blue Cross Blue Shield Association’s innovation chief told Bloomberg Law when explaining why the health insurer wanted to work on the NIH’s precision medicine study.
Maureen Sullivan’s description is particularly apt as precision medicine is an emerging approach that factors in a patient’s DNA—along with environment and lifestyle—to make targeted treatment and prevention decisions.
“We want our members to have the opportunity to really help shape the future,” Sullivan, the association’s chief strategy and innovation officer, said in an April 25 interview. The National Institutes of Health’s precision medicine work aims in part to understand what role personal health and wearable technology, such as Fitbit activity trackers and Apple watches, have in managing health care, Sullivan said. Data from this study could give the health-care industry more insights into managing care.
The Blue Cross and Blue Shield Association is one of several companies, along with pharmacy chain Walgreens and consumer health site WebMD, working with an NIH contractor to meet the agency’s goal of recruiting at least a million participants once the precision medicine study known as the All of Us Research Program opens May 6. NIH Director Francis S. Collins has described it as “the largest, most ambitious research project of this sort ever undertaken.”
Katie Baca-Motes, director of the Participant Center for All of Us, said recruiting a million or more participants over the next decade who reflect the diversity of the nation’s population requires thinking beyond traditional ways of recruiting research subjects, which rely heavily on academic health centers. Baca-Motes is also a director in La Jolla, Calif.-based Scripps Translational Science Institute, which received the NIH award to run the participant center.
“The partners that we work with are outside of the traditional clinical trial recruitment plans,” Baca-Motes said in an April 23 interview with Bloomberg Law. Health-care providers, such as federally qualified health centers that provide primary care services in underserved areas, will do a good chunk of outreach. But relying on providers is “still not going to get us to our goal of reaching anyone, anywhere in the country that wants to raise their hands and volunteer for this program,” Baca-Motes said. “So we put together a group of partners representing a broad spectrum of sectors,” including Walgreens and the Blue Cross Blue Shield Association.
Low clinical trial enrollment has aggravated researchers for decades. For example, fewer than 5 percent of adult cancer patients enroll in a clinical trial, and those rates are even lower for minority groups, potentially widening the gap in health disparities. “We need to have awareness all over the country if we are truly trying to reach everybody across the country,” she said, which is why they are turning to Blue Cross Blue Shield, whose 36 companies cover 106 million Americans. “Just the reach that our partners will enable is tremendous.”
Indeed, Sullivan said, “The fact that we insure one in three Americans is why we’re part of this.” The association already has projects that measure health down to the Zip code level, such as the BCBS Health Index. “We do that so we can understand where are the areas that need certain interventions,” she said, adding, “We’re confident we could have plenty of people interested in participating.”
Likewise, Walgreens operates 8,100 stores in all 50 states, the District of Columbia, Puerto Rico, and the U.S. Virgin Islands, according to a company fact sheet. The chain estimates it interacts with about 8 million customers, both in person and online. Walgreens will support the marketing efforts for All of Us, including online and social media promotion. Down the road, the company also will help collect medical information from volunteers through clinics at select Walgreens locations.
“With a local community presence throughout the country, including medically underserved areas, Walgreens works to improve the health of millions of people every day, representing a cross section of all Americans,” Pat Carroll, chief medical officer for Walgreens Healthcare Clinics, said in an April 25 statement. “Now, through the All of Us Research Program, we can offer people of diverse backgrounds a chance to volunteer in research that may improve the future health of all Americans.”
This new way of recruiting could serve as a model for studies beyond All of Us, Baca-Motes said. “That’s one of our big focus areas at Scripps.”
The participant center will be opening up in different pockets of the All of Us project over the next several years, Baca-Motes, said, with outreach, education, and awareness of the project. Some individuals will then be invited to go beyond the initial enrollment and online informed consent form. Those participants will fill out health surveys and have that information connected to their health records. People will be invited to have physicals to provide baseline measurements for researchers. They may also be asked to donate blood and urine samples. “We are going to be doing it in a way that enables us to reach the levels of diversity that we want in the cohort.”
The NIH has identified markets it wants to target for enrollment, Sullivan said. “Let’s just say we opened it up to all of our members, and we fill it up with everyone in one state or a certain demographic,” she said.
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