Minorities Are Underrepresented in Clinical Trials

What you might not know is that minorities also are woefully underrepresented in medical trials, and the issue is so pervasive that it could call into question the science that goes into new drug development.

For example, ProPublica and Stat reported this year that the FDA approved a new drug in 2015 after trials determined that patients taking the medication could go an average of six months without cancer spreading.

The problem with that trial, according to the report, is that although the drug in question is intended to treat multiple myeloma, there were only 13 black participants in a cohort of 722 patients. Twenty percent of Americans who suffer from the disease are black, but less than 2 percent of the patients studied were black.

The disparity isn't unique to a specific manufacturer. ProPublica found that in trials for 24 of the 31 cancer drugs approved in the past three years, less than 5 percent of the subjects were black. That's troubling when one considers that blacks account for 13 percent of the nation's population. Furthermore, blacks have the highest death rate and shortest survival rate of any group in the United States for most cancers.

FDA scientists noted in a 2017 journal article that underrepresentation of blacks in multiple myeloma research left unanswered questions about how the blood cancer affects black patients, their symptoms and their response to medication. Again, that's particularly alarming given that the incidence of the disease is as much as three times higher in blacks than in their white peers.

Jonathan Jackson, Ph.D., founding director of the Community Access, Recruitment and Engagement Research Center at Massachusetts General Hospital in Boston, told ProPublica that inadequate minority representation in clinical trials means that "we aren't doing good science."

"If we aren’t doing good science and releasing these drugs out into the public, then we are at best being inefficient, at worst being irresponsible."

The lack of representation isn't limited to blacks. ProPublica reported that although Asians were well-represented in trials conducted overseas, when at least 70 percent of a drug trial was conducted in the United States, Asians -- who account for 6 percent of the U.S. population -- accounted for less than 2 percent of patients. Furthermore nearly two-thirds of the trials reviewed had no Native Americans or Alaska Natives, who represent 2 percent of the population.

Several obstacles hinder efforts to increase minority participation, including financial and transportation issues, FDA reluctance or inability to require specific levels of minority representation, and mistrust of the medical community among minorities based on past injustices, including medical experimentation.

This issue hits home for me because I lost my mom to breast cancer, the most common cancer among black women. Oddly, black and white women have similar incidence rates for breast cancer, but black women have 40 percent higher mortality rates.  

Sadly, there are many missed opportunities when it comes to the inclusion of black patients in research studies intended to develop lifesaving treatments. As family physicians, we have opportunities to encourage and educate our patients with information to help them participate in these important studies. It is obvious that minorities need to be better represented, and issues such as mistrust of the medical community and other barriers truly need to be addressed to ensure better quality care for all patients.

Ada Stewart, M.D., is a member of the AAFP Board of Directors.