As the heart of modern medical research, clinical trials provide scientists with vital real-life data that can help prevent, detect and treat diseases – but these experimental trials historically have had an identity crisis: participants are overwhelmingly white and male.
“According to a recently published Tufts University study, from 2007 to 2017 about 76 percent of clinical trial participants are Caucasian,” says Liz Beatty who’s been in the medical research field since the 1990s, racking up 16 years as Director of Clinical Trials at Bristol-Myers Squibb. “This lack of diversity has been a big problem for the industry for a long time.”
But the landscape is shifting in the clinical trial world.
In February of 2022, the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act was introduced to boost diversity in clinical trials with the FDA requiring pharmaceutical companies to report clinical trial enrollment targets by demographics and to provide an action plan to achieve that diversity.
One of the more innovative strategies for bridging this diversity gap comes from Inato, the company behind, what currently is, the largest clinical trial platform for community-based research sites.
Established in June of 2020, Inato’s digital portal is making it easier for pharmaceutical sponsors to connect to and recruit from diverse racial and ethnic communities – where physicians at community sites can locate appropriate clinical trials for their patients, especially patients of color who may not be aware such resources exist for them.
Inato currently encompasses 1,300 community research sites on its fast-growing network that covers more than 70 disease areas and spans across 40+ countries. More than a half dozen of the top 30 global pharmaceutical companies are partnering with Inato – and more are expected to join.
“This is an exciting time to be in this industry,” says Ms. Beatty, who serves as Inato’s Chief Strategic Officer. Throughout her career, Ms. Beatty has witnessed underrepresented populations – Black, Asian, Latino, Native American, etc. – habitually missing from clinical trials. “You want participant makeup to reflect the census breakdown,” she told California Business Journal. “Then think about the disease prevalence in certain ethnic communities which are also missing out on opportunities.”
Recruiting participants who represent cultural and ethnic communities is equally a scientific objective and social justice issue.
Reimaging Accessible Clinical Trials
A big challenge for recruiting diverse populations is deeply woven into the way clinical trials have traditionally been done. Historically, the top 5 percent of research sites account for about 70 percent of trials – which are typically administered by pharmaceutical sponsors through major hospitals and academic centers.
Here’s where access comes into play; these sites are often far away from communities of color. Participants can be required to check-in regularly during the course of their trial – which can encompass months or years – and they are not usually compensated for travel time and expenses.
“We are basically flipping that model,” says Ms. Beatty.
The Inato solution bypasses those locations by partnering with community-research center sites. Here, private physicians take on a bigger role, as they walk with their patients during the clinical trial experience.
“Doctors and family physicians are a real critical piece here. Your relationship with your doctor is how many decide to join a clinical trial. It’s a major life decision, especially for people who are suffering from a disease,” says Ms. Beatty who adds that Inato reps often help doctors get selected for the trials that best meet their patients’ needs.
If their patient is accepted into a trial, doctors make sure trial protocols are followed as they monitor their patient’s experience, report side effects, etc. This way, patients get to interact with their familiar doctor and don’t have to travel long distances for check-ups.
In this model, pharmaceutical sponsors have access to previously untapped patient populations who are not tied into a specific hospital or academic site. That means additional rich data to fuel their findings. The end result: life-saving drugs can be available to the public in shorter periods of time.
Right Idea, Right Time
The Inato model debuted at the right time – just when the pandemic locked everyone down.
“During the early months of the pandemic, pharmaceutical companies were having an eye-opening moment,” says Ms. Beatty, explaining that they realized people didn’t want to travel to get to a clinical trial site. New recruits didn’t want to go to an unfamiliar hospital, preferring doctors they knew and trusted.
“COVID was a big opportunity for our industry,” she says. “And our model seemed exceedingly appropriate at the time – allowing people to have access to clinical trials and stay close to home.”
Now with less than two years under the belt, Inato is growing connections and making differences. The strategy is to continue to establish community sites in urban, suburban and rural locations. California boasts 80 sites across a variety of communities.
Ms. Beatty describes one hospital center in California that, because of Inato, has more access to clinical trials for their patients. “The hospital and staff have really close connections with the local Vietnamese, Pacific Islander and Hispanic communities. They developed these relationships over years, with outreach at churches and places of worship.”
This community site, like so many others, has been struggling for opportunities. “They are so excited to learn that now they can participate in the research and have that as an option for their patients,” she concludes. “They are so excited with the possibilities.”