According to Jodi Akin, clinical trials have what she calls “a very large accessibility problem.”
Akin is founder and chief executive officer of Hawthorne Effect, a healthcare startup dedicated to reimagining clinical trials. On the company’s website, the company states its mission is to “deliver innovative, accessible, inclusive clinical trials” in an effort to “[improve] the health and well-being of all humanity.”
Hawthorne Effect isn’t alone in this endeavor—or in this column. Last October, I interviewed Greenphire’s Jaleeysa King about her company’s own work in making clinical trials more diverse and accessible. King, a data analyst and co-chair of Greenphire’s diversity committee, said in part trials “currently do not adequately represent the full range of the population that is impacted by the disease being studied,” adding that “historically lacked data for minority ethnic populations.”
In an interview via email earlier this week, Akin explained Hawthorne Effect’s origin story traces back 8 years when, in 2015, she found herself faced with an opportunity to “correct the accessibility and diversity shortcomings in clinical trials while making research part of real-world healthcare for both patients and clinicians.” The industry’s problems have had profound effects on her life, both personally and professionally. Those experiences spurred Akin on a journey towards what she described as “health equity and quality solutions that merge clinical research and innovative technology with compassion and accessibility within clinical trial participants’ own communities.”
In a nutshell, Hawthorne Effect’s raison d’être is to fix the issues with clinical trials and accessibility and diversity. These shortcomings, Akin told me, have a tendency to result in less scientifically accurate trials that have immense reverberating costs. Not only do they cost billions of dollars in funding and function, the ultimate costs are “early deaths and poor health,” Akin said.
“At Hawthorne Effect, we’re doing both [solving accessibility and diversity] simultaneously,” Amin said of her company’s methodologies. “Our unique approach incorporating technology and a distributed network of certified medical professionals enables us to bring trials directly to the patient, in their home, versus them having to travel hundreds of miles multiple times a year for follow-up appointments in a clinical setting. Our Hawthorne Heroes network also comes from the patients’ trusted communities, making them feel more at ease and better represented.”
Akin cited a recent study whereby Hawthorne Effect “demonstrated our ability to reach diverse trial populations.” Results revealed Akin and team were able to get 15% Black, 3% Asian, and 10% Hispanic people enrolled in trials. These numbers, she said, are markedly higher than typical industry averages.
When asked who exactly is best served by more accessible trials, Akin was emphatic in responding that everyone is—even those who generally are bountifully represented in research. And yet, problems persist. “Sadly, so many barriers— economic, demographic, sociographic and more—remain in connecting patients with clinical trials. That’s something Hawthorne Effect has intentionally set about correcting,” she said.
Like with countless other industries, technology has quite literally made Hawthorne Effect’s work possible. Akin called the sheer existence of her company’s platform “unprecedented,” saying it was “built from the ground up to enable scalable, compliant, and high-quality clinical trial visits to occur in the home.”
The platform matters because, Akin said, it enables Hawthorne Effect to meet people where they are in their lives. The reality is, it’s difficult, if not impossible, for many people to miss work or get to a central location for trials. This is especially true for members of the disability community, whose logistical life in terms of managing transit and finances often must be dealt with with near surgical precision.
Measure twice and cut once, indeed.
“By meeting patients where they are most comfortable, in their homes, you are able to reach people who would have otherwise been unavailable,” Akin said. “Just a handful of years ago, it would not have been possible to do this in a way that was scalable from a logistics perspective or feasible from a quality and compliance perspective.”
Akin shared an anecdote about a 90-year-old woman named Opal. Opal, who started participating in trials at Stanford, was expected to travel thousand of miles for more than six months. Akin also pointed to staff workers juggling tight schedules, as well as parents of newborns being forced to consider dropping out of what she called “life-saving trials” due to travel concerns such as cost and distance.
But it isn’t only participants who can reap benefits from Hawthorne’s model. Akin said trial sponsors and industry partners benefit largely because modern technology allows for better outcomes. “By providing them with cleaner, faster, comprehensive datasets, Hawthorne Effect accelerates regulatory approvals and time-to-market, she said. [This is true] for complex trials or during times when the industry is facing unprecedented barriers of its own, such as during the COVID pandemic.”
Akin continued: “If we step back for a moment, what appears is an opportunity to connect research generally with patient care, making it part of the individual healthcare experience. Because our technology enables community clinicians to serve in trials, that brings the doctor-patient relationship back home and promises truly personalized treatments.”
Feedback on Hawthorne Effect has been positive, Akin said. It’s given the company opportunities to put their energy into trials that have “far-reaching impact.” Moreover, Akin told me the company feels they’ve reached an inflection point in the industry where a major paradigm shift is happening. “Change doesn’t tend to come quickly in our industry, or healthcare generally,” she said. “However, between the advancements in trial technology that Hawthorne Effect is using, the changes brought about by the pandemic and the willingness of regulatory groups like the FDA to engage and support new methodologies, we hear and see a great deal of enthusiasm in the industry around our approach.”
Going forward, Akin was forthright in saying her company has even bigger aspirations than making clinical trials more diverse and accessible. In the long-term, they wish to see trials become embedded within the overall continuum of care for every patient, such that research becomes part and parcel to how quality healthcare is delivered.
“If we can make trials accessible to all patients and physicians, that truly brings the patient-doctor relationship back home,” Akin said.
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