Improving Diversity and Inclusion in Cancer Clinical Trials and Research

Sometimes change isn’t only good, it’s necessary.

Researchers at the Herbert Irving Comprehensive Cancer Center (HICCC) and three collaborating institutions have been awarded a $6 million grant from Stand Up To Cancer® (SU2C) for their proposal to address the lack of diversity in cancer clinical trials including the underrepresentation of Black, Indigenous and people of color (BIPOC). The SU2C Health Equity Breakthrough Team includes Mary Beth Terry, PhD, director of the Community Outreach and Engagement Office at the HICCC and professor of epidemiology at Columbia University Mailman School of Public Health, and collaborators from cancer community outreach programs and initiatives at the Albert Einstein Cancer Center, Mount Sinai’s Icahn School of Medicine, and City University of New York (CUNY).

The team is a central part of SU2C’s Health Equity Initiative, a new initiative that requires all SU2C-supported research grant proposals to address recruitment and retention of BIPOC patients in cancer clinical trials. The SU2C Health Equity Breakthrough Team is the first to receive funding as part of this initiative.

Clinical trials ensure the safety and efficacy of novel drug treatments, medical procedures, or devices for the general public. Historically, clinical trial enrollees have been disproportionately white male and not ethnically and racially diverse, resulting in a significant health equity gap.

In recent years, there has been attention paid on promoting and improving diversity in scientific research, including in cancer clinical trials. In 2019, the Food and Drug Administration (FDA) issued guidance on increasing patient diversity in clinical trials. The FDA recently reported that only 4% of clinical trial participates are Black and 5% are Hispanic. This is despite the fact that BIPOC overall in the U.S. have both the highest death rate and shortest survival rate for most cancers.

For their proposal, Dr. Terry and collaborators are aiming to tackle this problem from the ground up.

“Our approach is to change the way we do things because the reality is what we’re doing  is good but it’s just not enough,” says Dr. Terry, who also co-leads the Cancer Population Sciences program at the HICCC and is an expert in cancer prevention strategies. “We’re taking a systems approach to solving this problem.”

The team’s project, DISRUPT, which stands for Diversity & IncluSion in Research Underpinning Prevention and Therapy Trials, will focus on three areas. It will work with community organizations to raise awareness about cancer research in communities where people are not as informed about the latest cancer treatment and research breakthroughs. The team will train scientists and doctors to better understand how life circumstances affect the health of certain communities, and the importance of engaging with and including a diverse group of patients in cancer research and clinical trials. It will also explore ways to better inform underrepresented patients about clinical trials, including creating a digital patient navigation system that will link patients with clinical trials in the New York City area, across various institutions.

“Typically, we start with a great big scientific or research discovery and then we figure out how can we have a diverse population to bring this to,” says Dr. Terry. “Many people aren’t presented with clinical trials until they have advanced disease, which is a challenging time to first hear about clinical research and trials. We have to start with the community, instead of ending with the community.”

At Columbia, HICCC members and faculty across the university are involved in ongoing studies into the diverse areas of health disparities research. In breast cancer, for one, researchers are investigating the toxic side effects of the costs of cancer, biological drivers of breast cancer survival, and optimizing mammography screening in older women.

A unique component of the team’s project is a proposal to match basic scientists with a partner from one of the cancer centers’ community-based organizations. This will be rolled out via a new pilot grant program, across the institutions, as a way to engage basic scientists more closely with a community collaborator.

“It’s important for people in the community to be full partners in developing and promoting clinical research and to understand community needs so we are all working toward a common goal,” says Dr. Terry. “On the patient side, our project will focus on matching people with the right clinical trial for them regardless if it’s at our own institution, and on the research side, connecting scientists in our labs to the people who live on the block where they work.”

Dr. Terry will be collaborating on this new project with Nina Bickell, MD, MPH, professor of population health science and policy at Mount Sinai; Karen Hubbard, PhD, professor of biology at CUNY; and Bruce Rapkin, PhD, professor of epidemiology and population health at Albert Einstein Cancer Center. The grant will support their project for the next 4 years.

“Certainly because of the COVID pandemic we’re in an environment where even with the ground we’ve made in improving diversity and inclusion in the past, we may have lost some of that ground,” says Dr. Terry. “We’re really at a time where we can re-think how we do things, collectively.”