Charlotte Jones-Burton, M.D., M.S., cardiovascular development team lead, Innovative Medicines, is no stranger to clinical trials. A nephrologist by training and currently the clinical development lead for a number of programs at Bristol-Myers Squibb, she has a deep understanding of the well-orchestrated task of embarking upon a new clinical program. But in Charlotte’s view, there remains a critical need across clinical trial development — diversity.
Though it is known that there are differences in racial and gender response to medicines, women and minority groups have been historically underrepresented in clinical trials, limiting findings on response from the full breadth of potential patients. However, according to Charlotte, if we want to include a representative group of patients, the work begins long before a trial begins enrollment.
“When most people think about diversity in clinical trials, they think of diversity of patients — and that’s true, but it goes far beyond that,” says Charlotte. “I challenge my teams to think about drug development along a spectrum, and it’s vital that we think about diversity at each step — beginning with the clinician and other key opinion leaders informing the strategy and design of the trial.”
Charlotte notes diversity and inclusion throughout the entire duration of the trial is vital in gleaning insights from areas most affected by a particular disease.
“If we’re using cardiovascular trials as an example, the disease area has high burden for women and a number of different racial groups — when we’re putting together an advisory board, we need to make sure it includes gender and ethnic diversity. And the same for every other step of the design process,” Charlotte says. “If their experience and expertise lead the design of the trial, that will help identify site locations where patients are most affected by heart disease, and ensure we are enrolling the right patients.”