Rachel Sherman, MD, the FDA’s principal deputy commissioner, said that she’s “not entirely satisfied” with minority enrollment but that clinical trials have become more diverse in other ways. Two decades ago, women and children were rarely included in drug studies. Now those groups are better represented and the FDA is working on including more minorities, she said.
Dr. Sherman added that the agency has to balance how much information it demands from drugmakers against the need to get a drug onto the market, where it will be broadly available for all patients.
“When it comes to clinical research in this country, there’s a credit card, and there’s a limit on the credit card,” she said. “If we spend on one thing, it won’t get spent on another. We have to be judicious in what we require and what we demand and what we encourage.”
Diversity has its trade-offs. Clinical trials already cost hundreds of millions of dollars, and drugmakers say that requiring participants to be racially representative would likely add more time and expense.
“If you have a significant delay in enrollment, that would delay the medication advancing to the whole patient population, hurting everybody including the black population,” said Dr. Maraganore, who also is CEO of drugmaker Alnylam Pharmaceuticals.
To offset costs caused by these delays, manufacturers might reduce the number of drugs in development, depriving some patients of experimental treatments, or raise prices, which would translate into higher insurance premiums and make new drugs even less affordable for the uninsured. Dr. Maraganore favors improving diversity through patient education – “a carrot-based approach” – rather than government regulation.
Despite these short-term expenses, eliminating racial disparities in clinical trials would ultimately save costs through disease prevention and improved treatment, according to a 2015 analysis by researchers at the University of California, San Francisco. Without FDA pressure, though, manufacturers may be unlikely to increase efforts to recruit blacks, especially if their sights are set on a worldwide market. They can use the same clinical trial data to gain approval in the European Union or Japan.
Takeda, which is based in Tokyo, tested Ninlaro in the United States, Japan, and 24 other countries, including Australia, Austria, Denmark, New Zealand, Sweden, and others with small black populations. “Clinical trials are reflective of the ethnicity distribution in the population where the study takes place,” Phil Rowlands, head of Takeda’s oncology unit, said in an email. “While we cannot control enrollment eligibility based on the strict clinical criteria, our recruitment efforts extend to diverse patient populations, including minorities.”
Asked why Takeda didn’t pick sites with higher black populations, Mr. Rowlands said that Takeda does not “select sites with ethnicity as an eligibility criteria unless specific risk factors require that.”
Income is another reason for sparse African American representation. Clinical trials are largely a middle-class option. A 2015 study found that patients with an annual household income below $50,000 had 32% lower odds of participating in a trial than did patients with income above that threshold. The median household income of black Americans in 2016 was $39,490, compared with $65,041 for non-Hispanic white Americans.