Diversity in clinical trials critical to refining medicines and therapies
Leaders from Northwell Health’s Feinstein Institute for Medical Research, the FDA and Boehringer Ingelheim recently led a symposium on the barriers and opportunities to increase patient diversity in clinical trials. Because medicines may affect people differently based on age, sex and race, the diversity of clinical trial participants is important to better anticipate differences in treatment effects once the medicines are on the market.
“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, M.D., director of professional affairs and stakeholder engagement at the FDA. “We see in the data that, for example, a very small percentage of African Americans participates in clinical trials in the U.S. I hope to see collaborations formed in the future to address the issue of diversity in clinical trials.”
During his presentation, Dr. Whyte referred to FDA findings recently posted online.
“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 8.3 million people who live in Northwell Health’s service area throughout Long Island, New York City and Westchester County, two million are Hispanic, 1.1 million are Asian and 1.05 million are African American, according to Dr. Raju. Queens represents 28% of Northwell Health’s service area. The borough is the most ethnically diverse urban area in the world, with 75% of the population being non-white.
Currently, the Feinstein Institute enrolls more than 15,000 subjects per year into more than 2,100 active studies.
“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 Ingelheim Pharmaceuticals. “Partnerships like these are especially critical to help the healthcare industry better serve the needs of all of the patients we serve.”
Boehringer Ingelheim is the world’s largest privately-held pharmaceutical company. Headquartered in Ingelheim, Germany, it has approximately 50,000 employees who are dedicated to improving the health and wellbeing of mankind. Over the past decade, Boehringer Ingelheim has conducted approximately 1,350 clinical trials with over 640,000 patients globally.
The diversity in clinical trials symposium was coordinated by Northwell Health Pharma Ventures and Boehringer Ingelheim. Northwell Health’s Pharma Ventures group was established in 2015 to manage and develop collaborative and strategic relationships with the pharmaceutical industry.
“Northwell Health is perfectly positioned to be a leader in recruiting minority populations in clinical trials based on our location and the demographics of our patients,” said Elaine Brennan, managing director of Pharma Ventures at Northwell Health.