Every year new drugs are approved for human use by CDER (the Center for Drug Evaluation and Research), a division of the FDA. Approval is based on safety and efficacy measures that come from clinical trials. Some of those trials feature fewer than 10 patients, while others have several thousand. It’s no secret to anyone in the industry that in recent years FDA has placed a greater emphasis on including certain subgroups in clinical trials, namely women and racial minority groups.
In a recent blog post, John Whyte, director of professional affairs and stakeholder engagement at CDER, notes until the late 1980s, clinical trials were conducted primarily on men. But a lot has changed over the last 30 years. We now know that some drugs affect men and women differently.
“For instance, women are often prescribed only half the dose that men take of the sleep medication Ambien (zolpidem),” notes Whyte. “Race and ethnicity also make a difference. One type of drug commonly used to treat high blood pressure, angiotensin-converting enzyme (ACE) inhibitors, has been shown to be less effective in African American patients than in Caucasian patients.”
Whyte states this is why it is important for sponsors to test drugs on the appropriate patient populations, especially when developing “novel drugs” (new medicines that have never been used in the U.S. marketplace). Over the last two years, CDER has approved 67 novel drugs. This approval number is just one reason the agency has a growing interest in including people of different ages, races, ethnic groups, and genders in clinical trials.
Two years ago CDER piloted the Drug Trials Snapshots program to provide information about patient representation in trials. Snapshots show who participated in the studies and organizes the information by sex, race, and age subgroups. They also provide a brief narrative, by subgroup, on whether there were any reported differences in how a drug worked and side effects.
CDER recently released its Drug Trials Snapshots Summary Report for the years 2015 and 2016, which provides a yearly average of the diversity of participants in clinical trials for novel drugs approved in those years. Whyte states the report shows good news for the industry regarding participation by both women and African Americans in trials. In 2015, women were represented at a rate of 40 percent. That figure jumped to 48 percent in 2016. African Americans were represented at a rate of 5 percent in 2015, which climbed to 7 percent in 2016. Participation by Asians dropped slightly from 12 percent in 2015 to 11 percent in 2016.
In 2016 participation was highest for African Americans in trials for medicines treating mild to moderate eczema and inhalational anthrax. For women, the numbers were highest in bladder cancer, ovarian cancer, primary biliary cholangitis, dry eye disease, and multiple sclerosis.
“At its heart, this report is an effort to be transparent – to provide information to the public and actually show the number and participation of men and women, of various races and age groups, within the clinical trials,” adds Whyte. “Being able to share more information and facts will help us to facilitate a thorough and robust discussion about clinical trial demographics. Now, anyone can go to the site and see the numbers for themselves in a quick snapshot.”
The Drug Trials Snapshots Summary Report can be seen here. If you would like to hear more from John Whyte and his insights into the FDA’s perspectives on diversity in clinical trials, plan to attend Clinical Leader Forum, being held May 10-11 in Philadelphia. John will be a presenter for a session on patient diversity challenges. Click here to see our complete list of speakers and moderators.