Adding Color to Clinical Studies

by Jane Ehrhardt


Adding Color to Clinical Studies

Tiffany Whitlow and Del Smith.

Clinical trials in the U.S. will soon more accurately represent people who will utilize the treatments, thanks in part to a Birmingham company.

Currently, on average, less than 10 percent of clinical research populations include minority participants. Yet according to the latest national census, 42.2 percent of Americans are minorities. This misrepresentation in clinical trials leads to incomplete data for doctors to work with when treating patients because medications can act differently among races. For instance, albuterol, the most commonly prescribed bronchodilator in the world, showed diminished effectiveness in 47 percent of African-American and 67 percent of Puerto Rican children. But twice as many black children have the disease as white children.

Acclinate, which was founded by Tiffany Whitlow and Del Smith, wants to help solve this problem. "We want to provide pharmaceutical companies with better data so they have better research," says Whitlow, who serves as the development officer. "We are not a clinical trial recruitment firm. Instead, we focus on building relationships with the black community. Our company works to educate and engage the population that researchers need in clinical trials."

On the flip side, Acclinate works with biopharmaceutical companies and contract research organizations to help them understand that their current process doesn't include the entire spectrum of possible patients, along with advising companies on how to make changes. "We are the partner who helps them make these operational changes and make them sustainable," Whitlow says. "And they're able to use our technology to find out who is most likely to participate and/or which clinical trial sites might yield the type of return they're looking for."

The technology is a HIPAA-compliant database, dubbed EDICT which stands for Enhanced Diversity in Clinical Trials. "It's like a heat map," Whitlow says. "It shows where a population might be, how engaged they are, how many were offered a trial, and how many have been screened for a trial."

Finding interested companies came surprisingly easy for the two-year-old business. "A lot of them found us," Whitlow says, adding that Covid-19 advanced the need for inclusion in clinical trials to the forefront of the industry. "More guidance came out about clinical trials. So if you were enrolling for the Covid-19 vaccine and you didn't show diversity, they stopped your enrollment. It was a problem for the industry. They knew they had to be part of that solution."

Add in the social unrest, and companies began to actively seek out black-owned businesses to partner with. "So our phone rang for one or the other reason," Whitlow says. With headquarters in Birmingham, Acclinate now has small offices at HudsonAlpha Institute for Biotechnology in Huntsville, and another at Johnson and Johnson labs in Washington DC across from the FDA. Google invested in the company and provided them with access to developing AI models to manage their data.

"The pharmaceutical industry needs to understand how internally widespread their approach needs to change to permanently alter recruitment in clinical trials," Whitlow says. "They need changes to happen from the time they think and plan a trial to post-marketing of who is the drug going to and who knows about it.

"Right now, pharmaceutical companies ask potential participants once and if that person declines, the company moves on. We tell them that it's better to invest in building a community and in educating people because the people who say no now can one day be the best participant for your next trial," Whitlow says.

Acclinate wants the black population to know that clinical trials are an option for attaining treatment. When Whitlow's grandfather needed a hearing aid, he had to buy one for $6,000. Her grandmother, who recently needed one, balked at that price. So Whitlow went online and found a clinical trial near her. Her grandma enrolled and received a free hearing aid as part of her participation.

"People get afraid that a clinical trial is always something have to swallow," Whitlow says. "But sometimes it's for something you need day to day, like hearing aids."

They reach the community through their website, www.nowincluded.com site where they invite people to share their stories of medical situations and treatments in order to help people learn about healthcare options which, hopefully, empowers people in making healthcare decisions.

The latest digital outreach expands on that concept. Launching January 22, www.binclusive.com will include the option for healthcare providers and service companies to post videos, as well as learn how the black community views healthcare with both their perspective and experiences. "This can help healthcare providers understand at what point people are making healthcare decisions, like why they waited until they had Stage 4 cancer to come in," Whitlow says, adding that the more healthcare providers participate and learn from these conversations, the better the outcomes for everyone.

To join the online community for conversations about black health, visit https://nowincluded.com

To become part of our collective of people who are focused on improved health, overall wellness, and elevated financial practices, visit https://b-included.com