The American Heart Association (AHA) said it got more than 8,000 women to sign up for an ambitious health study, as it teamed up with Google sister-company Verily to boost female representation in research .
The AHA announced its collaboration with Verily in late February to engage women in Verily’s Project Baseline study, as well as to boost their participation in research overall. As many as 86% of studies fail to recruit enough participants, and 30% of participants drop out after joining. Women, and women of color in particular, have long been underrepresented in scientific research.
“We needed to change that,” said Mariell Jessup, M.D., AHA chief science and medical officer, at a panel discussion earlier this month at the Icahn School of Medicine at Mount Sinai during which she recapped the effort.
The AHA and Verily’s collaboration, dubbed Research Goes Red, was designed to raise awareness of the impact of cardiovascular-related issues on women in the U.S. and directly engage women in the research process by specifically addressing the historic gender gap. The AHA got the word out to women through its digital channels, including Facebook.
Technically speaking, the women participants signed up for the Research Goes Red (RGR) registry, not for a specific study. As of July, more than 107,000 had visited the RGR page on Project Baseline’s site, with nearly 26,000 having registered and a further 8,600 having consented to participate in the research—well beyond initial goals for all three benchmarks, according to Jessup. Participants also have the option of further consenting to join other research opportunities through Project Baseline.
Ashley Moulton, head of clinical partnerships for Project Baseline, at Verily, said several thousand participants were enrolled in Baseline’s health study ahead of February 2019, but declined to provide a gender breakdown.
Hardware and software advances have made it easier to recruit patients for clinical trials and—thanks to digital monitoring and the ability to interact with biosensors, wearables and mobile apps—technology has also improved the experience for patients taking part in studies. But even as digital tools bring much-needed innovation to the clinical trials space, the case study highlights the potential for trust and other issues.
It’s fairly common for advocacy groups to work with life sciences companies in this capacity. The nonprofits rely on biopharma for financial and scientific support and, in turn, the groups can return the favor in the form of access to repositories of patient data and other benefits. (The organizers of Research Goes Red say no money changed hands in association with the AHA-Verily collaboration.)
Making it easier for people to participate in research was a big impetus behind the 2017 launch of Baseline, which seeks to define what it means to be healthy and to delineate the transition to disease using the data of 10,000 volunteers. For instance, Verily touts how it’s brought a user-centered design focus and easy-to-use mobile technology to clinical research and life sciences.
“We have tens of thousands of people in our Baseline Registry—our community of people interested in research opportunities; and several thousand people enrolled in the studies we currently offer (including our landmark Project Baseline Health Study),” Moulton told MM&M by email.
But not everyone is familiar with the company. Verily, which is the life sciences arm of Alphabet, was founded in 2016. Formerly called Google Life Sciences, the somewhat enigmatic firm has raised $1 billion from investors. But the company’s relative newness along with its association with Google, which is not a name people typically associate with clinical research, may have led to a potential trust issue.
During the Q&A segment of the panel discussion, the panelists were asked about barriers, including privacy and incidents of hacking, that may prevent patient groups from partnering further with healthcare professionals and biopharma.
Patient registries and studies have historically struggled to recruit patients. Verily was looking for new ways to recruit historically underrepresented populations, such as women.
“When we signed on, [we were all] just overwhelmed with how many patients we could get to join,” Jessup answered, “and that’s because the American Heart Association’s spent 100 years gathering the trust of the American people.
“And Verily…first of all [relatively few people have] heard of Verily,” she continued, “and then if you say, ‘Oh, it’s [related to] Google,’ you think, ‘Well, I don’t know—.’ So I think that’s one of the problems with big IT is that there’s no trust.”
A 2018 survey from Rock Health, released in February of this year, found that when it comes to whom the average American would rather share their health data with, tech companies lagged behind pharmaceutical companies, health insurers and the government. According to results of the 4,000-person study, only 11% of respondents were willing to share with a tech company like Google or Facebook.
Among respondents saying they would share their health data with a tech company, Google (60%) was the most trusted company, ahead of fellow techies Amazon (53%), Microsoft (51%) and Apple (49%). Still, only 7% of total respondents were willing to share with the search giant.
“It is unclear how consumers’ unwillingness to share health data will hinder the growing number of tech companies making healthcare plays,” Rock Health said at the time.
Verily has told CNBC that the company uses Google ads to find patients based on health-related searches, and suggests that they join the project. It also works with health systems Stanford Medicine and Duke Medical Center, which were early partners, and has since added Mayo Clinic and University of Pittsburgh which, along with patient associations, help spread the word among patients about volunteering for medical studies.
Yet just partnering with a patient group doesn’t eliminate any potential for patients to view a clinical trial-related promotion with a jaded eye. “It opens a door in terms of willingness to consider the study,” said one marketing executive at a top-10 biopharma company who wished to remain anonymous. But, “Do they see it as coming from a trusted friend? No, absolutely not. I haven’t seen that leap.”
“There’s a level of skepticism and doubt when it comes through a manufacturer, or [even] through a neutral site, of ‘Who’s really behind this?’” added the executive.
Another reason many trials have struggled with recruitment is low awareness. Among cancer patients, for instance, awareness of clinical trials is “dismally low,” said Ellen Miller-Sonet, chief strategy and alliance officer for the non-profit group CancerCare.
Only 18% of patients being treated in academic medical centers said they had been given enough information about trials, Miller-Sonet said, also during the Mount Sinai talk. The rate was only 12% for those getting treated in community cancer centers, according to a study commissioned by her group.
Advocacy groups can help fill this gap, if they exist. Only 50% (or less) of the 7,000 rare diseases actually have an organized patient group, said rare diseases commercial consultant Wendy White, another member of the Mount Sinai panel, and only 500 of these illnesses are commonly in a doctor’s repertoire.
In the absence of an advocacy group, a life sciences firm can align with an umbrella group, like Global Genes or the National Organization for Rare Disorders (NORD), said White, who is a board chair of Global Genes and a former NORD board member.
In the rare disease area, a trusted partner can not only help with clinical recruitment; they can also assist a biopharma company in understanding clinically meaningful endpoints and then educate patients about the clinical trial process, according to White.
“Especially in the rare disease space, you need patients’ cooperation,” said White. “There’s been a big push in [this] space to not have placebo-controlled clinical trials, [which are] the gold standard. … You have to educate people around that.”
The need is great, particularly when it comes to female representation. Since Congress mandated the inclusion of women in NIH-sponsored clinical trials in 1993, 49% of U.S. clinical trial participants are women, compared to about 43% globally, according to statistics cited by Jessup. (The NIH says the percentage is a bit higher.) Of female cardiovascular disease clinical trial participants globally, 78.7% are white with only 3.2% representing black or African American women.
Research Goes Red was a joint effort that leveraged AHA’s long-running Go Red for Women movement, a very impactful program which has raised $600 million to support research since its 2004 inception. Together with National Wear Red Day, annually the first day of February (traditionally followed by a fashion show of red dresses), Go Red generates about 4.5 billion media impressions a year through local and national communications channels.
Through Go Red and other efforts, AHA estimates having about 1.1 million followers, subscribers and active supporters in its Go Red digital network. The partners sought to leverage that network to build the world’s most engaged women’s health registry and research marketplace. (There were other goals of the Project Baseline study, as well, including deep phenotyping and physical exams.)
Women over 18 who are U.S. residents have been able to sign up on the project Baseline site since the beginning of February. Organizers promised to make it easier for women to enroll in clinical studies, stay up-to-date with research and cardiovascular innovations that apply to them, as well as contribute data for clinical research projects and be among the first to test new tools, technologies and treatments.
Once in the research program, the AHA also surveyed women to find out their motives for signing up. Most (18%) cited access to care/paying for healthcare and/or medications as their no. 1 reason; followed by weight (16%); and then memory, brain function and/or healthy aging (10%).
“Interestingly, the younger women are more interested in healthy brains than the older women,” said Jessup, adding that the organizers plan to fund three or four research grants around those topics and to provide a “menu of potential clinical trials for these women.”
The next phase of recruitment is to expand beyond the Go Red community and to tap into some of AHA’s other patient communities, Jessup said.
For its part, Verily is “continuing to work with the AHA on opportunities to promote research studies to women and to underscore the importance of inclusion in research,” Moulton said.
This includes furthering its cardiovascular research. In May Verily launched the Heart Biomarker Study, an observational research study which collects health records of eligible participants who have experienced a heart attack or stroke.
That same month, Verily also announced partnerships with Novartis, Sanofi, Otsuka and Pfizer in an effort to modernize clinical trials. Verily and the pharma companies want to reach patients in new ways, according to the announcement, make it easier to enroll and participate in trials and aggregate data across sources.
UPDATE: After this piece appeared on Sept. 19, the AHA added the following statement: “Combining the AHA’s 100-year history building trust and community with Verily’s state-of-the-art technology is accelerating world-class clinical research on women’s heart health. We were both overwhelmed by the positive response, which clearly demonstrates this initiative is resonating with women.”
This story has been updated to clarify that recruiting historically underrepresented populations (like women) into research was the impetus for the collaboration between the AHA and Verily, and not classic recruitment struggles.
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