Patel’s Research Highlights Need for Increased Diversity in Cancer Studies

Cancer can impact anyone, but in the United States, marginalized groups have higher rates of cancer and cancer-related mortality than White Americans. The reasons behind these disparities are complex. While socioeconomic status, health care access, and personal behaviors are primary drivers of disparities, there is evidence some groups may be at higher risk of cancer and respond to treatment differently because of hereditary factors.

Cancer clinical trials are studies that aim to find new ways to identify, treat, and prevent cancer. These trials are critical to high quality cancer care because they provide objective evaluations of the safety and effectiveness of new cancer treatments. However, research coming out of clinical trials may not be generalizable to all populations if the studies do not include a diverse group of trial participants.

Institute for Diversity Science Affiliate Monica Patel is an oncologist who works at the University of Wisconsin’s Carbone Cancer Center. In addition to her medical practice, Dr. Patel serves as Faculty Director of Diversity and Inclusion in Clinical Research at Carbone and conducts research that looks at ways to diversify cancer clinical trials. Researchers have known about the lack of diversity in cancer trials for a few decades, but so far, efforts to correct the problem have not resulted in major changes. Although people of color make up around 40% of the U.S. population, recent research finds that they only make up around 15% of participants in cancer clinical trials. “We worry about safety, as well as the efficacy of the results of a study if it doesn’t have equitable representation of all of our patients,” says Dr. Patel. Participation in clinical trials is relatively low across all groups, and studies show that among patients with fewer economic resources, other health issues, and minority status, participation is lower.

There are challenges to diversifying enrollment in clinical trials at nearly every step of the process, says Patel. Trials can include people who have cancer, people who are at higher risk of cancer, and healthy individuals, but participants typically need to be recruited for trials by their physicians or by study coordinators. Dr. Patel’s research especially looks at communication around recruitment, how potential participants decide whether to participate in trials, and whether practices around trial eligibility may contribute to lower levels of diversity within trials.

In one recent study, Patel and colleagues found that inclusion and exclusion criteria for trial eligibility significantly affected trial participation. Fewer trial opportunities were available for patients with less common cancers. Potential participants were sometimes ineligible to participate due to abnormalities in lab results, disease stage and history, and co-existing diseases. Patel and her coauthors recommend that trials aiming to increase participation consider broadening eligibility criteria.

Dr. Patel is optimistic that we may begin to see greater diversity in cancer clinical trials. One driving factor for improvement is coming from the Food and Drug Administration (FDA), which has established an equity program for cancer research centers. In June of 2024, the FDA published guidance for cancer centers recommending that centers submit a diversity action plan as part of the process for seeking FDA approval of a trial. The FDA has acknowledged areas needing additional study, including defining appropriate data sources to set benchmarks for oncology studies and more standardized methods for measuring patients’ demographic characteristics to ensure representation.

The sorts of research efforts being driven by Dr. Patel and others have real world implications. They increase the safety of care for cancer patients and help to ensure that patients receive effective treatments regardless of their background.


Monica Patel is a faculty member in the Division of Hematology, Medical Oncology and Palliative Care within the University of Wisconsin Department of Medicine. She is the UW Carbone Cancer Center Faculty Director of Diversity & Inclusion in Clinical Research and is an affiliate of the Institute for Diversity Science.