The FDA this week released its Drug Trials Snapshots Summary Report, a document that looks at the diversity of the participants in trials for new drugs that were approved last year and in 2015. There’s a lot to be excited about. For example, women accounted for 48% of participants in trials in 2016, up from 40% the year before. And African-Americans represented 7% of trial subjects last year, up from 5% in 2015.
So why is this so important? Although you may not realize it, drugs can act differently if you are a man or a woman, and even based on a person’s race or ethnicity. Studies found that dosing of the sleep aid Ambien in most women should be half that of men.
Other trials found that African-Americans on Coumadin (warfarin), the gold standard of anticoagulants, require higher doses to achieve the same therapeutic effect compared to western European and Asian populations. And with the cholesterol-lowering medication Crestor (rosuvastatin), through additional research, it was discovered that in Asian populations there should be a lower starting dose to minimize the possibility of side effects.
For decades, white men were the vast majority of clinical trial subjects. Seniors were often excluded from clinical trials, even though they typically take many more drugs than younger adults. And pregnant women were deliberately left out of trials for many, many years, which meant that if a pregnant woman needed to take a drug, doctors simply had to guess at what impact it might have on the pregnancy and the fetus.
With the increased diversification of participants, we now have a better understanding of not only the efficacy of new drugs between the sexes and ethnic groups, but if side effects occur at different rates in different populations.
While the FDA’s report paints a mostly positive picture on the diversity of clinical trial participants, the reality is not quite so rosy. Last year, 76% of trial participants for new drugs that were approved were white. Caucasians still dominate the clinical trial registries. And only 21% were 65 years of age or older. Asians were represented in trials just 11% of the time. From my view, the only bright spot is that women accounted for nearly 50% of participants.
The FDA has made it a priority to boost minority representation in trials. Last year, the agency started a new initiative dubbed The Year of Clinical Trial Diversity. As part of the effort, the FDA’s Office of Minority Health has developed tools to boost minority participation, including a multimedia campaign designed to encourage those who are underrepresented to find out more information and consider enrolling. In one of the videos, a woman with sickle cell disease talks about her experience participating in clinical trials and encourages others to learn more.
Also, the FDA’s Office of Women’s Health launched the Diverse Women in Clinical Trials initiative. The effort intends to raise awareness and share best practices about clinical trial design, recruitment and analyses of subpopulations.
All in all, there has been significant progress in boosting the diversity of trials for new drugs. While the FDA’s new report indicates that, it also shows there’s a long way to go before true diversity is achieved.