The development of new medicines is a major reason medical science added 20 years to global life expectancy in the past century. But the pharmaceutical industry’s role as healer is sorely diminished if we don’t develop medicines fairly for everyone who needs them, regardless of income, gender, race, geography, or ability.
Unless we bring medical innovations to everyone, everywhere, equally, we fail in a mission where failure is not an option.
Equity and diversity in clinical trials—the gateways to new medicines—benefit both patients and our business. We do the most good and generate better scientific insights by studying our medicines in populations representative of the people suffering from that disease. Accessing the totality of the patient pool lets us move medicines from trials to delivery faster.
The U.S. Food and Drug Administration has taken note. The FDA has published draft guidance, and recent legislation has been signed into law on improving diversity in clinical trials. As such, pharmaceutical companies will be required to submit diversity plans for late-stage trials to improve enrollment for underrepresented groups and enhance health equity.
Making clinical trials representative of actual patients
In 2020, Bristol Myers Squibb announced a five-year, $150 million program to address health disparities and improve clinical trial equity. We are seeing promising results.
Traditionally, most U.S. Clinical trials take place in large teaching hospitals. To increase diversity, we used U.S. Census data to locate our research sites in highly diverse areas (places with highly diverse U.S. Communities greater than 25%). Thanks to multiple efforts not limited to the work of community groups, local hospitals, and technology companies dedicated to health equity, as of October 2023, 62% of our active research sites are located in highly diverse communities.
Black men are 50% more likely than white men to develop prostate cancer, and twice as likely to die from it. Yet clinical trials for prostate cancer treatments historically enroll just 9% Black men.
Working with Black Health Matters to design trials and create appropriate educational and recruitment materials, BMS has doubled the number of Black men enrolled in BMS prostate cancer trials.
In partnership with Disability Solutions, BMS is understanding the challenges that traditionally underrepresented people with intellectual, developmental, and physical disabilities are facing when participating in a clinical trial. BMS is also working to understand the needs of the LGBTQI+ by allowing adult patients in the U.S. To self-identify their sexual orientation, gender identity, and intersex status.
Crucial to our mission has been our work to build trust in communities that have historically been resistant to signing up for trials.
To foster and sustain that trust, the Bristol Myers Squibb Foundation, a separate entity from BMS, has pledged $100 million to cosponsor the Robert A. Winn Diversity in Clinical Trials Award Program to train, develop, and mentor nearly 600 diverse and community-oriented clinical trialists and medical students by 2027.
Technology + humanity = equity
The desire for parity is the starting point, but it’s advances in technology that are helping make equity real.
When the COVID pandemic kept patients from clinical trial sites, we learned how to remotely analyze electronic health records and other data to keep trials going. We realized the technology also allowed us to enroll a patient population that looked more like the real world.
On the near horizon are clinical trial “digital twins”—virtual representations of patients built on historical data and analyzed by artificial intelligence. Digital twins will allow us to simulate the biological processes and outcomes of human patients, expanding our capability to recruit widely diverse populations for trials.
Digital technology is helping make clinical trials more equitable on a national and global basis.
In the U.S., we’re connecting underserved and understaffed community hospitals virtually with medical specialists who not only conduct and evaluate trials but help treat current patients.
Globally, we’re working with technology companies to design inclusive trials and recruit diverse participants in both developed and low- and middle-income nations around the world.
We’ve made encouraging progress, but more work remains. Clinical trial participants industrywide are 75% white, 11% Hispanic, 8% Black, and 6% Asian. Our industry can and must do better.
‘Who are you working for?’
One consistent mantra at BMS is the question, “Who are you working for?” It’s a deeply personal way to connect each of us to our core mission: delivering medicines to help patients prevail over disease.
Every one of our 34,000 colleagues has a family member or a friend urgently waiting for necessary medicine.
In a larger sense, the answer to “Who are you working for?” Is the unknown patient anywhere in the world suffering from illness and looking to medical science for relief.
For me, there’s an additional layer. One reason I devoted my term as BMS CEO to equity and diversity is the unique responsibility of my job.
Being a CEO isn’t necessarily 10 times as hard or 10 times as demanding as previous roles I had. The main difference is the sense of accountability that comes with the office. When I was CEO, I had responsibility in some ways for what happens to 34,000 families. And, of course, the millions of patients depending on us to help them triumph over illness and disease.
Giovanni Caforio, MD, is executive chairman of Bristol Myers Squibb. Bristol Myers Squibb is a partner of Coins2Day’s Brainstorm Health and CEO Initiative.