Diverse Clinical Trials Necessary for Better Treatments

Study finds that most clinical trials lack diversity, which could affect known treatment responses.

Different ethnic and racial groups have a higher prevalence of certain diseases due to various factors. These factors can also cause these groups to respond to medications differently, which is why clinical trials generally aim to enroll a diverse patient population.

In a recent symposium, leaders from the Feinstein Institute for Medical Research, the FDA, and Boehringer Ingelheim discussed the importance of diversity in clinical trials and current barriers.

Since medications affect individuals differently based on age, sex, and race, ensuring diversity among patient populations enrolled in clinical trials can better identify potential treatment differences after the drug is approved, according to a press release.

“We know that some people may react differently to the same drug. In an attempt to better understand variability in drug response, FDA conducted analysis stratifying clinical trial participants by different demographics such as sex, age, and race,” said John Whyte, MD, director of professional affairs and stakeholder engagement at the FDA.

During the symposium, Dr Whyte discussed findings from the Global Participation Clinical Trials Report, which outlines where clinical trials are being conducted and who they include.

“Healthcare is a fundamental civil and human right,” noted Ram Raju, MD, senior vice president and community health investment officer at Northwell Health. “We know that patients who participate in clinical trials have better health outcomes. That is why it is my mission to ensure that our community — a community that likely is the most diverse of any health system in the country – better understands and is open to participating in clinical research. I want to ensure that any patient can access our cutting-edge care.”

Of the more than 8 million people who are in Northwell Health’s area, 2 million are Hispanic, 1.1 million are Asian, and 1.05 million are African American, Dr Raju said during the symposium.

Queens accounts for 28% of their service area and has a very diverse urban population, with 75% being non-white, according to the release. Populations such as this are important to include in clinical trials since investigators are able to get a more accurate view of the drug’s effects on different patient groups.

“We are interested in developing partnerships with the FDA and large health systems, like Northwell Health, so that we can enroll more diverse patients earlier in trials, and ultimately deliver innovative medications to patients faster,” said Sabine Luik, MD, senior vice president of Medicine and Regulatory affairs at Boehringer. “Partnerships like these are especially critical to help the healthcare industry better serve the needs of all of the patients we serve.”

The goal of the symposium was to highlight the gaps in current clinical trials and how diversity could improve the drugs that come to market.

“We see in the data that, for example, a very small percentage of African Americans participates in clinical trials in the United States,” Dr Whyte said. “I hope to see collaborations formed in the future to address the issue of diversity in clinical trials.”