Diversity, Equity, and Inclusion in Cancer Clinical Trials

Background: The increasing diversity of the U.S. population necessitates meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products, as emphasized by Food and Drug Administration Commissioner Robert M. Califf, M.D. Ensuring this representation is crucial for developing treatments that effectively address diseases disproportionately impacting diverse communities. Similarly, Health Canada’s Health Products and Food Branch has enhanced its ability to collect disaggregated data to assess diversity in clinical trials, as part of its sex- and gender-based Analysis Plus Action Plan. Starting in 2022, sponsors submitting clinical trial data were required to report diversity metrics by sex, age, and race to establish a baseline for monitoring and improvement. Methodology: This was a desk-based, quantitative study using secondary data from clinical trial registries like ClinicalTrials.gov and EudraCT, along with cancer and epidemiological databases. Data on ~80,000 cancer clinical trials were collected, excluding terminated trials, and analyzed using Microsoft Excel. Multivariate analysis included therapeutic area, trial phase, participant demographics, and disease incidence. Bias was minimized through careful data processing. Results: The study revealed disparities in cancer clinical trial participation across racial and ethnic groups. White/Caucasian individuals had the highest participation in Europe and North America, whereas Asians dominated in the Asia-Pacific (APAC) regions. Black/African Americans showed significant participation in Africa and North America. Regional mortality and trial phase breakdowns also highlighted variability in racial representation, with Phase IV trials having the most diverse participation. In addition, age group analysis indicated higher Asian participation in elderly trials and White/Caucasian dominance in pediatric trials. The data underscores ongoing racial disparities in global cancer clinical trials. Conclusion: This study highlights significant regional and racial disparities in cancer clinical trial participation. Key findings reveal lower participation among Black/African American and Native American/Indigenous populations, and a dominance of White/Caucasian and Asian groups in North America, Europe, and APAC regions. To bridge these gaps, targeted efforts, including barrier identification, awareness campaigns, and collaborative initiatives, are essential. These findings stress the need for inclusive recruitment strategies to ensure diverse representation in clinical trials, leading to more equitable and generalizable healthcare outcomes.