By Clinical Informatics News Staff

June 15, 2016 | On Sunday the Food & Drug Administration is launching the first phase of a campaign to encourage minorities to participate in clinical trials. With a series of six videos, blogs, and an infographic, FDA hopes to increase awareness about clinical trials in minority communities and encourage discussion and participation.

Robert Califf, FDA’s Commissioner of Food and Drugs, announced in January that 2016 would be FDA’s Year of Diversity in Clinical Trials. “Historically, the elderly, women (in some therapeutic areas), and racial/ethnic minorities have been underrepresented in trials,” Claiff said.

FDA had already launched Drug Trials Snapshots, a way for anyone to quickly see who participated in trials for a particular drug, but the 2016 efforts are meant to more proactively engage minorities in trials, rather than just report on past participation.

In a blog post, Jonca Bull, FDA’s Assistant Commissioner for Minority Health, Office of Minority Health, previewed the videos, called for minorities to be “clinical trial champions,” and explained FDA’s role in encouraging minority participation.

“Clinical trials participants need to more closely mirror the patients who will ultimately use the medicine,” Bull writes. “This is especially important when considering health disparities — diseases that occur more frequently or appear differently in non-white populations. But most clinical trials participants are white and male... If we do not develop a more diverse pool of research participants, health disparities may persist because we will not know if a medical product is safe and effective in the actual population that will ultimately use it.”

All six of the videos are short: the longest is two minutes long, and most are about 30 seconds. Five of the six videos feature Shirley Miller, a black woman living with sickle cell disease. Miller talks about her experience participating in clinical trials and encourages her peers to learn more about research studies. She talks about how to find out about trials, how important diversity is in trials, and how healthy volunteers can help.

“I got involved in clinical trials because I wanted to be able to take advantage of some of the new treatments that come out,” Miller says in the longest video. She addresses some common fears—that patients would have to stop their current medications and that trials are unsafe—and she encourages minorities to participate. Sickle Cell disease, for example, primarily affects people of African and Hispanic descent. “It’s very important for the demographic to match the disease that it’s being researched for,” she says.

In the sixth video, Luciana Borio, FDA’s Acting Chief Scientist, discusses why clinical trial diversity matters from FDA’s perspective. “We know that sometimes women, elderly persons, and people of varied ethnic backgrounds can respond very differently to medical products,” Borio says in her one-minute video. “So it is important that patients who are most likely to use these products are included in these clinical trials.”

For more on diversity in clinical trials and to see what steps pharma is taking to improve diversity, see “The Diversity Problem: Making Clinical Trials Work for Everyone”.