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Clinical Trials

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COVID-19 Vaccine Clinical Trials Lack of Diversity

The COVID-19 pandemic has disrupted the entire world, disproportionately and adversely impacting certain segments of the population. It is well established that the population over the age of 60, those with underlying health conditions, and African Americans are particularly vulnerable to the COVID-19 virus. Black Americans also continue to experience the highest mortality rates, more than twice the rate for whites and Asians. The battle against this virus required pharmaceutical and biotech industry-wide mobilization to rapidly develop an effective vaccine.

Data published by Oxford University on the Astra Zeneca vaccine group confirmed that over 90% of the 1077 healthy volunteers in Phase 1 and 2 trials were white. A similar lack of diversity was found in the Moderna, Pfizer, and BioNTech vaccine clinical trials. It is clear that “modest” attempts were made to recruit a diverse population of trial participants.

Unfortunately, these companies continue to use the same “industry-wide” patient recruitment techniques that have provided the same poor patient recruitment results for decades. The absence of adequate representation of all population subgroups results in data that is not readily generalizable to all members of the affected population.

Based on all the outcomes data available, it stands to reason that the groups with the highest incidence and mortality rates needed to be heavily represented in all of the pivotal vaccine studies. It has been well established that African Americans are a genetically diverse group. The higher degree of genetic heterogeneity can impact how drugs are metabolized, effective dosing, immune responses, and adverse events. Therefore, the CDS model is needed.
We must first take a deep dive into the “true” reasons why African Americans fear medical research. Once this data is gathered and understood, a trusted process for African American participation in medical research can be developed and implemented. Significantly increasing African American representation in clinical trials will directly impact the health, life expectancy, and disease outcomes of this high-risk population.

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