MANHASSET, NY, and RIDGEFIELD, CT —
Leaders from Northwell Health's Feinstein Institute for Medical Research, the US Food and Drug Administration (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, MD, 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 United States. 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.
"Health care 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 percent of Northwell Health's service area. The borough is the most ethnically diverse urban area in the world, with 75 percent 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, Inc. "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.
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About Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, CT, is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
Boehringer Ingelheim is one of the world's top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, the company operates globally with approximately 50,000 employees. Since its founding in 1885, the company has remained family-owned and today creates value through innovation for three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing.
Boehringer Ingelheim is committed to improving lives and providing valuable services and support to patients and their families. Our employees create and engage in programs that strengthen our communities. Please visit our website to learn more about how we make more health for more people through our Corporate Social Responsibility initiatives.
In 2016, Boehringer Ingelheim achieved net sales of about $17.6 billion (15.9 billion euros). R&D expenditure corresponds to 19.6 percent of its net sales.
For more information please visit www.boehringer-ingelheim.us, or follow us on Twitter @BoehringerUS.
About the Feinstein Institute
The Feinstein Institute for Medical Research is the research arm of Northwell Health, the largest healthcare provider in New York. Home to 50 research laboratories and to clinical research throughout dozens of hospitals and outpatient facilities, the Feinstein includes 4,000 researchers and staff who are making breakthroughs in molecular medicine, genetics, oncology, brain research, mental health, autoimmunity, and bioelectronic medicine – a new field of science that has the potential to revolutionize medicine. For more information about how we empower imagination and pioneer discovery, visit FeinsteinInstitute.org.
Erin Crew, Boehringer Ingelheim
Emily Ng, Northwell Health