Clinical Drug Trials Still Don’t Account For Race, & Here’s Why It Matters

by JR Thorpe
Ashley Batz/Bustle

If you're a person who takes medication, from aspirin to chemotherapy drugs, it's probable that you'd prefer that your medication be tested on people who are, you know, like you — but more often than not, medical trials tend to use white men as their test subjects, leaving women and people of color in the lurch. This reality has been getting better in recent years, however: A new study from the Journal of Women's Health reveals that more women are being represented as test subjects in clinical drug trials in the United States, but people of color are still underrepresented.

Up until 1993, the Food & Drug Administration made drug testing a man-only business; it was only at that point that women of child-bearing age were allowed to participate in drug trials at all. (It used to be thought that being test subjects might endanger female fertility and health.) From there, it's been an uphill struggle to get women into drug trials in equal numbers, and the FDA itself has done a lot of work to encourage better gender parity in drug testing. But while the story is good for women's representation in drug testing, the study, which reviewed 102 new drug applications submitted to the FDA between 2013 and 2015, revealed that when it comes to race, representation in testing is still not catching up — and this has tremendous repercussions.

Women Are Gaining Ground In Drug Trials

The necessity of women's representation in drug trials isn't just a symbolic issue. Medications can have very different consequences and effects on different genders. In 2013, the FDA had to cut the recommended dosage of zolpidem, otherwise known as Ambien, for women by half because the conventional dose (which had been designed based on men's needs) was causing overdoses in women. As the researchers behind this new study point out, everything from hypertension medication to muscle relaxants has been found to have different effects on women, and not including women in the clinical trials for these drugs can have extremely poor consequences.

The researchers looked at 2,455 clinical trials with a total of 484,896 participants for the 102 drugs, excluding any medications that were purely sex-specific or for children. And they found good developments when it comes to women's participation. After the FDA came down hard on trials for not reporting gender at all in their subjects, 99.9 percent of the trials the researchers looked at reported participant genders. Women accounted for 40.2 percent of trial participants: 46.6 percent in 2013, 37.7 percent in 2014, and 39.2 percent in 2015. It's not equal parity, but it's an improvement from years past.

The people behind the trials were also factoring in gender into their studies, not just reporting it: 99 of the 102 drugs analyzed how effective the drugs were in different genders, and 97 of them had studies about safety in women. 95 had both. That's a very big jump from previous years: older studies showed that efficacy and safety tests that accounted for gender only showed up in 47.2 to 91 percent of drugs. The ones that didn't have them this time were for very rare diseases, and the sole drug that didn't have effectiveness or safety tests for women was for HER2-positive breast cancer, and their male sample size was so small it didn't make sense to do analysis by gender.

The big trend the researchers noticed? Later-phase trials had more women. When a drug goes through the hoops of approval, it has to go through three trial phases. As they progress, the trials start to focus exclusively on people who have the disease itself, and to include as many sufferers as possible to see exactly how effective it might be if released into the world. Women became a big part of the picture the closer the drugs got to being licensed, and that's an important plus.

But People Of Color Are Still Not Represented Properly

When it came to the people of color represented in the 2,455 clinical trials, the story was not as good. Proper racial representation in medication trials is important; though our understanding of how people of different races react to different medications, it's crucial that drugs aren't just tested on white men and then marketed as safe for everybody, just in case a previously unknown complication reveals itself. And on that front, the news from the study wasn't as stellar.

97.5 percent of the trial participants recorded their race, and the results showed that 77.2 percent of all the people tested were white, 12.2 percent were Asian, 6.4 percent were Black/African American, 2.6 percent were Other, 0.6 percent were Native American, and 0.6 percent were Hispanic/Latino. (For context, as of 2016, 17.8 percent of Americans were Hispanic or Latino, according to the census.) Non-white people made up between 13.9 and 33 percent of the total.

The thing about taking race into account is that it's viewed as a good representation if it corresponds to percentage numbers in the population. Compared to the Asian population in the U.S., the percentage of Asian clinical trial participants, at 12.2 percent, was pretty high. That's good! But the percentage of Black people averaged around 6.4 percent, which is way below the number of Black people in America (around 13.3 percent of the total U.S. population).

"Participation of some racial minorities — most notably, Blacks/African Americans — is still not well represented in many programs and remains an area in need of improvement," the scientists behind the study noted in their conclusion. They raised the possibility that one of the reasons Black people miss out is that these big drug trials now involve countries other than the U.S., which may not have the same population of Black people as the U.S. But it's something that needs to be addressed; otherwise, the medications on our shelves haven't truly been tested for everybody's safety and health.