How to reach under-represented women in clinical trials

Linda Goler Blount, M.P.H. has engineered a HIV tracking system. She’s conducted formula management at a top beverage company. She even lived in the Caribbean while working for the Centers for Disease Control and Prevention. In her diverse and professional travels, there’s one thing she’s always seen – black women confront a variety of barriers that impact their health and wellness. Now, her mission is to solve those most pressing health issues as the president and CEO of the Black Women’s Health Imperative.

“It’s important for black women to take care of themselves, but they don’t always have the same access to care or the data doesn’t properly reflect what’s happening in their world,” says Blount. “We hear headlines like breast cancer rates have fallen, but are increasing among African-American women with no other explanation. That’s just one example of needing to dive deeper into the research to understand why.”
 

In Blount’s position, she is constantly approached by pharmaceutical companies in hopes BWHI can connect them with black women for their trials and studies. “I’m not in talent recruitment,” says Blount. “What I tell them is to think about why they’re reaching out to me and let’s talk about how we can overcome this obstacle of including black women.”

Then she met someone who already had a solution. Blount watched Charlotte Owens, M.D., medical director, general medicine and virology, AbbVie, present details about a clinical trial that not only included African-American women, but kept them in the trial for more than two years. Blount could hardly believe it.

“You rarely hear about studies including significant numbers of black women, but here was a trial that did just that and quite frankly I was blown away,” says Blount.
 

Keeping patients in a clinical trial isn’t easy. One analysis points to an 18 percent drop-out rate of patients.¹ “Many clinical trials are just weeks or months-long. The study team and I were studying women with uterine fibroids for more than two years,” Owens explains.

It wasn’t just retention as Blount pointed out. It was about the diversity and accurate representation of the patient population. Owens, an African-American woman who describes herself as coming from humble beginnings, brought those personal experiences into the approach of putting this trial together. For African-American women, uterine fibroids seem to occur at a younger age and they grow more quickly.²

“Our trial was unique because many of our women may not have seen a doctor in years. A majority of the women were African-American, under-insured or had no insurance and some may have had a systematic feeling of distrust with clinical trials,” Owens describes. “I feel so proud of the work our team did.”
 

As part of the study, the trial team had to collect every single sanitary product, every month for over a year. Owens knew this was a big request, so through a vendor the team asked the women how they could make participation easier. For example, many of the patients take public transportation. Imagine having to get on a bus or train with a bag full of used sanitary products. Owens’ team provided tote bags to remain inconspicuous.

That’s not all. Owens says some sites opened offices early. They stayed open late. They helped with transportation so the women could get to the clinics that were sometimes out of their neighborhood. They provided food because the women had to fast for blood draws. The team used a vendor who developed an app to send texts alerts to the patients, and finally someone was available every day and at any time.

“All the sites had my cell phone number and could call me 24/7 for questions or concerns. Accessibility and trust are important,” says Owens.

That accessibility was critical during 2017 during Hurricanes Irma, Harvey and Maria. In Puerto Rico, Florida and Texas for example, Owens says the study sites and AbbVie team went above and beyond to make sure they stayed connected with the women and the study staff despite the disaster that displaced people and left some clinics without power for weeks.

“The commitment to keep this clinical trial true to the patient population is rare and really impressive,” says Blount of Owens’ work. “She was respectful. She valued the women and that message came across loud and clear.”

BWHI plans to continue partnering with AbbVie. Blount says as the society’s racial and ethnic composition continues to evolve, clinical trials and studies need to keep up with those changes so that every group has a chance at better health.