Diversity in Clinical Trials - The Challenges Highlighted by COVID-19

Posted by Heather Pitt on Dec 15, 2020 10:30:02 AM

As the pharma industry worked to identify and create a safe and effective COVID-19 vaccine at warp speed, this urgency highlighted one of the greatest challenges affecting modern pharmaceutical research, a lack of diversity in clinical trials.

A 2020 report published by the Tufts Center for the Study of Drug Development that evaluated the diversity of pivotal clinical trials on experimental medicines between 2007 and 2017 found that female, Black, and Latinx participants were chronically underrepresented, while male and Asian participants were over-represented. Positively, participation amongst Hispanic/Latinx populations did increase during the ten years studied. However, representation of Black participants did not. Additionally, the study found that only 37% of the trials evaluated had reported data on the ethnicity of their trial participants, which could raise questions about the broader effectiveness of the treatments amongst more diverse patient populations if not included in the study.

From the pandemic’s earliest days, COVID-19 hit Black, Latinx, and Native American communities hardest, where the mortality rate has been more than twice that of whites (Centers for Disease Control and Prevention). Many explanations have been offered including that minorities are more likely to be impacted by systemic health care inequalities, less access to care, and more likely to work at riskier frontline jobs.

Any vaccine tested on a population that is not diverse enough may not help the people most in need of it. That makes diversifying these trials an absolute necessity and this means recruiting volunteers from the communities that have been hit hardest. The overall goal for any trial is to ensure that the trials are at least as racially diverse as the country in which it is being conducted, with patients recruited that reflect local demographics.

Companies with ongoing COVID-19 investigational therapies and vaccines trials have placed a heavy emphasis on diversity, bringing the industry-wide issue to the global stage. For example, Moderna slowed enrollment of its late-stage trial whilst instructing its site staff to place focus on increasing participation amongst minority volunteers.

As stated at the outset, it’s not just trials for potential COVID-19 treatments that face diversity issues. Many other indications also show higher prevalence in particular ethnic or minority populations. In oncology for example, it is known that different types of cancer are more prevalent in some demographics than in others.

To change the trend, pharma must evolve trials to ensure that all treatments are being tested on the populations most seriously affected by the disease. This will require investment in community education and outreach, especially in communities that have historically been underrepresented to help to accelerate the development of life-changing treatments in the future.

In the next blog in this series, we’ll discuss some of the specific ways pharma companies can improve diversity in their clinical trials.

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Topics: Clinical Operations, Challenges, COVID-19, Clinical Trial Diversity, Diversity in Clinical Trials

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