Clinical trials are essential for developing new treatments and advancing healthcare. However, these trials are not always representative of the diverse patient population they are intended to serve, leading to disparities in healthcare outcomes. Racial and ethnic minorities, women, older adults, and individuals from low-income communities are often underrepresented in clinical trials. In this article, we explore the issue of disparities in clinical trials and highlight strategies and success stories in addressing this problem.

The statistics on disparities in clinical trials are staggering. According to a study by the Food and Drug Administration (FDA), African Americans make up only 5% of clinical trial participants, despite representing 13% of the US population. Hispanics are similarly underrepresented, making up only 1% to 6% of clinical trial participants. According to a report in the Washington post, Women are also underrepresented, accounting for only 39% of clinical trial participants. Older adults are often excluded from clinical trials, despite being the largest consumer of healthcare services.

Before we highlight the implications and strategies to address these disparities we should pay attention to the drivers that brought us here. The Institute of Medicine. 2003. Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care. highlighted many of these issues and strategies in which to address them.

These disparities in clinical trials have serious implications for healthcare outcomes. For example, African Americans have a higher incidence of certain cancers, but are less likely to participate in clinical trials for cancer treatments. This means that there is limited understanding of how these treatments work in African American patients, which can result in disparities in healthcare outcomes. Similarly, women are often excluded from clinical trials for cardiovascular disease, even though heart disease is the leading cause of death in women in the United States.

To address these disparities, there are several strategies that can be employed. One approach is to increase outreach and education efforts to underrepresented communities. For example, the FDA has launched campaigns to increase participation of African Americans and Hispanics in clinical trials. These campaigns provide information about the benefits and risks of clinical trials and encourage participation in research.

Another strategy is to prioritize diversity in clinical trial design and recruitment. This means designing clinical trials that are representative of the patient population they are intended to serve. For example, the National Institute of Health (NIH's) All of Us Research Program is designed to include a diverse group of participants, including individuals from underrepresented communities. This approach ensures that research findings are more applicable to a wider population.

A strategy that has not been prioritized is the strength of a diverse healthcare workforce. In particular the pipeline of diverse healthcare workers along the clinical trial journey. Research has shown that there is a longer life expectancy and lower mortality in black populations with a higher prevalence of black doctors.

Success stories in addressing disparities in clinical trials include the development of new treatments for rare diseases. For example, Spinraza, a treatment for spinal muscular atrophy, was developed with the help of patients and patient advocacy groups; Cure SMA provided the first research funding needed to begin investigation into this therapeutic approach. By engaging patients and their families in the clinical trial process, the researchers were able to design a trial that was more representative of the patient population.

Addressing disparities in clinical trials is critical to advancing healthcare and reducing disparities in healthcare outcomes. By increasing outreach and education efforts, prioritizing diversity in clinical trial design and recruitment, and engaging patients and patient advocacy groups, we can ensure that clinical trials are more representative of the diverse patient population they are intended to serve. Through these efforts, we can work towards closing the gap in healthcare outcomes and improving the lives of all patients.

What are you doing towards achieving health equity in clinical trials? It takes a village so let's collaborate!