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Working together to make clinical trials inclusive

Tom Popper
Tom Popper
November 16, 2021

It stands to reason that clinical trials will give more meaningful results if they involve a diverse population that mirrors society at large. But including a truly representative demographic sample is a challenge that few clinical trials meet.

“As of today, Hispanics represent one in five people in the US. If you’re not adequately including one in five people in this country in clinical trials, you’re not having effective clinical trials,” Adolph Falcon, Executive Vice President for the National Alliance for Hispanic Health, told a panel during a recent virtual BIO Patient Advocacy Coffee Chat.

“Inclusion is not only a social goal,” Falcon said. “Inclusion really goes to the core of good science and well-run clinical trials.”

‘I was not asked’

Falcon outlined the problem: Despite making up about 20% of the general population, Hispanics’ participation in NIH clinical trials is around 8%—and less than that for FDA trials. “Worst of all are genome-wide association studies,” where the population pool is less than 1% Hispanic, he said.

Yet surveys find Hispanics are more eager than non-Hispanic whites to participate in trials. “The number-one reason Hispanics are not participating in clinical trials is ‘I was not asked,’” surveys show, according to Falcon.

A similar scenario was described by Joshua Tarnoff, CEO of NephCure Kidney International, which focuses on Nephrotic Syndrome, a rare and dangerous kidney condition.

“Although Black Americans represent 13% of the population, they represent over a third of end-stage kidney disease” patients, Tarnoff told the panel. Yet most people receiving experimental treatments for kidney diseases “tend to be wealthy people, predominantly white, because they have access to the university of fill-in-the-blank, where this care often resides.”

BIO launches website to drive clinical trial diversity

Addressing the problem requires cooperation from all stakeholders, including regulators, clinicians, patients and industry, Tarnoff said. “We very much work closely with industry because at the end of the day, that’s how we get new therapies, and we all have the same goal: We want to help patients.”

Helping patients is the purpose of BIO’s new Clinical Trials Power of Participation website, explained Khushboo Sharma, BIO’s Vice President of Science and Regulatory Affairs.

The site provides science-based information to help patients and their families understand the clinical trial process and learn where to enroll in clinical trials. It also includes a large section on diversity in clinical trials, with a description of what companies are doing to improve diversity.

“With the creation of this website, we’re hoping to make it easier for the public to understand how clinical trials work and how to enroll in clinical trials,” Sharma said.

‘High-touch’ solutions

The work to include more Hispanics in clinical trials is both “high-tech and high-touch,” said Falcon. High-tech solutions for diversity include the All of Us Research Program at NIH “that is looking to enroll over 1 million people to create the new research database for the future.”

As for “high-touch,” Falcon’s group supports initiatives like promotores, lay health workers who spread health information in the Spanish speaking community, to help people understand clinical trials and to ease their entry into the university centers that conduct the trials. The National Alliance for Hispanic Health collaborated with All of Us to set up a mobile unit that goes across the country sharing information, including in Spanish, in individual communities.

NephCure’s approach includes a pilot program involving two large churches with Black congregations in Chicago and in Atlanta. NephCure first shares information at health fairs organized by those churches and then comes back to do screenings before service on Sunday.

“If you do test positive. Then we hold your hand,” said Tarnoff, giving guidance on care and clinical trials.

Holding hands

When it comes to giving a personal touch, the people at the Children’s Inn at NIH are experts. They run a private non-profit residence on the grounds of the NIH in Bethesda, MD.

“Our goal is simple: To keep patients together with their families during serious illness, reduce their stress and promote and sustain a healthful environment built on mutual support,” Cathy Morales, Chief Program and Services Officer, told the panel.

Children’s Inn is also helping people understand and join clinical trials, said Aisha Campbell, Director of Resident Services and Family Programming at the Children’s Inn. The goal is to “help the clinicians get information to families but then also help families access that information.”

Cooperation between all stakeholders must continue, said Tarnoff. “What we’re trying to do is that, at the end of the day, clinical trial enrollment looks like the rest of America, not what it is today.”