Age, sex, comorbidities, and race can all be crucial elements of medical decision making. Clinical Research Organizations strive to obtain a diverse group of participants, yet continually fail to accurately reflect the demographics of a diverse population. So, why is diversity in clinical research studys so important? And how can the medical community improve its history of inequitable study?
Diversity in clinical research studys
Why Is Diversity in clinical research studys Important?
Statistics from a 2019 BIO Conference panel discussion revealed that racial and ethnic minorities make up 39 percent of the population in the U.S. Unfortunately, estimated rates of trial participation for that group range from about 2 to 16 percent. Another group of researchers assessed 230 oncology trials and found that, while many studies didn’t include participant race data at all, on average, 76.3 percent of the participants were white. Finally, drug company Pfizer recently published 10 years’ worth of diversity data from its clinical research studys. The Pfizer results show that, between 2011 and 2020, Black or African American participants made up 14.3 percent of 212 trials for which racial data was collected. And while Black Americans represent about 13.4 percent of the U.S. population, only about half of Pfizer’s studies surpassed census levels for Black participants.
Why Is There So Little Diversity in clinical research studys?
There are a wide variety of factors that may contribute to the lack of diversity in clinical research studys. First, race-based inequities in health insurance coverage mean that minority populations are less likely to seek specialty care, and thus, be exposed to clinical research study opportunities. For some communities, language barriers and transportation access can also be an issue. Additionally, perhaps the most troublesome factor is a general distrust toward medical research. That distrust has roots in the medical community’s dark history of abusing communities of color. Take, for example, the Tuskegee Syphilis Study, an ethically abusive study run by the U.S. Public Health Service between 1932 and 1972. Throughout the study, researchers failed to obtain informed consent. They never treated study participants with syphilis, instead choosing to study the effects of the disease as it progressed. Shockingly, researchers did this without informing trial participants.
How Can Trial Facilitators Prioritize Diversity?
The Food and Drug Administration (FDA) recently published recommendations entitled “Enhancing the Diversity of clinical research study Populations – Eligibility Criteria, Enrollment Practices, and Trial Designs.” These recommendations “provide the agency’s current thinking on steps to broaden eligibility criteria in clinical research studys through inclusive trial practices, trial designs, and methodological approaches.” Here are a few examples of the recommendations:
- Reducing patient burden during long-term studies (for example, trials that require frequent visits)
- Offering flexibility in visit windows
- Leaning into electronic communications, such as phone, email, and social media
- Broadening certain study eligibility criteria to increase diversity
- Broadening pediatric development programs
- Fostering community engagement through medical societies, focus groups, community advisory boards, disease registries, and community-based participatory research
The FDA has taken steps to address the lack of diversity in clinical research studys, but the medical community still has a long way to go. By studying disparities in diversity, researchers may move toward more equitable, accurate trial practices.
Have you ever thought about participating in a clinical research study? QPS Missouri is looking for new participants. Since opening its doors in 1994, QPS Missouri has conducted over 1,000 FDA-regulated studies, paying out over $35 million to local participants. Your local participation could have a global impact, as QPS is an international leader in contract research with facilities in North America, Europe, and Asia. Our mission is to accelerate the development of drugs worldwide by enabling breakthroughs in pharmaceutical innovation. This includes several pediatric studies across several age ranges. If you would like to join us in this crucial healthcare mission, consider applying for a clinical research study.
To get started, you simply need to fill out an online application. Within 48 business hours, a recruiting coordinator will contact you for your pre-screening assessment. Finally, to learn more, please visit the QPS Missouri website, review the study participation process, or check out our list of frequently asked questions.