Diversity plays a major role in the ability to examine the impact of therapies specifically in clinical trials. Developing novel therapies within a diverse patient population has posed a challenge for the biotechnology and pharmaceutical industry as well as clinicians. There are many conflicting reasons why diversity representation is challenging even in cases where the disease severely impacts underrepresented populations. Diversity includes race, age, gender, and disease. There is considerable data showing underrepresented populations are not as trustworthy and understanding of the role clinical trials play in improving health outcomes. A research team lead by Emily Rencsok conducted research to investigate the current and future of clinical trial diversity.
The method of this study involved seventy-two global phase III and IV prevention, screening, and treatment prostate cancer clinical trials. The enrollment dates examined were between 1987-2016, providing a total of 893,378 trial participants. The data points accessed were representation of race and ethnicity data, changes in diversity, and geographical representation.
Results of this data driven study included 72 trials analyzed and 59 had race data. It was determined the majority of the clinical trial participants were white men, compromising over 96% of the study population. This number has continued to be at least 80% since 1990. The study concluded that trial participants continue to be overwhelmingly white despite awareness of racial disparities in prostate cancer clinical outcomes.
To drive improvement in prostate cancer clinical outcomes for African Americans, Latinx patients, and other underrepresented groups, there is a need for more diverse enrollment into novel treatment trials. To make these changes, current and future clinical trials must leverage innovative recruitment strategies to increase enrollment of underrepresented men including partnering with community organizations and other trusted partners.