Inclusion of Diverse Participants in Pragmatic Clinical Trials

Pragmatic clinical trials are designed to evaluate the effectiveness of medical intervention in real-world settings. They are typically conducted among a heterogeneous population of patients, including individuals from different racial and ethnic groups, socioeconomic backgrounds, and geographic regions.

The Problem/Main Issues of Lack of Diversity in Clinical Trials and Possible Solutions

Minority groups have long been underrepresented in clinical trials, which has resulted in a lack of data on how diseases and treatments affect these groups. This lack of diversity leads to disparities in health care and stymies the development of new and more effective treatments. Despite recognizing the problem, the healthcare industry has been slow to address it.

Barriers to Inclusion

Many barriers prevent diverse participation in clinical trials.

• One of the main issues contributing to the lack of diversity in clinical trials is that a disproportionate number of minority group members live in poverty. According to a 2019 report from the Kaiser Family Foundation, minorities are more likely than whites to live below the federal poverty line, with 14% of Hispanics and 19% of Blacks meeting these criteria compared to 8% of whites. This socioeconomic disadvantage results in fewer minority group members having access to healthcare, lowering their likelihood of enrolling in clinical trials. 

• Another issue is that minorities often mistrust the healthcare system due to a history of exploitation and discrimination. For example, the Tuskegee Syphilis Study, which ran from 1932 to 1972, was an infamous study in which 600 poor Black men with syphilis were left untreated so that doctors could observe the disease’s progression. After decades of secrecy, the study came to light and confirmed many Blacks’ suspicions that they could not trust the healthcare system. As a result, even today, there is still a great deal of mistrust among minorities towards clinical researchers, which deters them from participating in trials.

• One more barrier is a lack of awareness; many people simply do not know that they can participate in clinical trials or how to sign up for them.

• Finally, logistical difficulties such as transportation and child care can prevent people from participating in clinical trials.

Best Practices To Solve the Issues

Best practices/solutions to these issues are:

• Researchers should make a concerted effort to recruit patients from a variety of backgrounds. It may require partnering with community organizations or reaching out to traditionally underrepresented groups in clinical research. Additionally, researchers should strive to create an inclusive environment that welcomes all patients.
• Increasing outreach and education about clinical trials within minority communities.
• Community health workers can play a crucial role here by serving as trusted messengers who can help dispel myths about clinical research and increase awareness about opportunities to participate in trials.
• Financial incentives such as stipends can help offset the costs associated with participating in a trial, making it more feasible for those living in poverty. Or financial barriers must be removed as much as possible to ensure that everyone has an opportunity to participate in clinical trials.
• Working with community-based organizations that serve minority populations can help increase trial enrollment by increasing trust and building relationships between researchers and potential participants.

By taking these steps, we can begin to rectify this long-standing problem and ensure that everyone has an equal opportunity to participate in clinical research.

What’s Next?

While pragmatic clinical trials should include a diverse range of participants, some challenges come with this. Clinicians and researchers must be aware of these challenges and work together to overcome them to ensure that the trial results accurately reflect the population. Doing so can better understand how treatments work for different groups, ultimately leading to more personalized medicine.