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Leveraging RWE & Outcomes for Minority Groups

Leveraging Real world evidence (RWE) & Outcomes for Minority Groups in Successful Trial Research

As the impressive pace of Covid-19 vaccinations continues in the U.S. with the goal of bringing the pandemic to an end, disparities in vaccine rollouts and hesitancy continue to affect racial minority Americans. As of mid May 2021, only 15% of Hispanic Americans and 16% of Black Americans were fully vaccinated against Covid-19, compared to 25% of White Americans.

But racial minority Americans being left behind in the pandemic isn’t new. In the initial large-scale clinical trials of both the Pfizer/BioNTech and Moderna mRNA vaccines, only 10% of participants were Black Americans, whereas they make up 13% of the U.S. population.

harmonizing data collected in randomized controlled trials with real-world evidence

Aiming for proportional representation is often the goal of randomized controlled trials (RCT) whether it be for vaccines, drugs or other medical interventions. However, even if proportional representation is achieved, this methodology still means that medical innovations are tested on considerably fewer racial minority Americans compared to white Americans. For example the Pfizer/BioNTech vaccine was only initially tested on around 4,000 Black Americans, compared to 33,000 white Americans. Specifically with regards to Covid-19, racial minority Americans remain more likely to get Covid-19 and are also more likely to die or have severe disease than White Americans and vaccine hesitancy remains a substantial barrier for many racialized communities.

However, this issue isn’t specific to Covid-19 vaccines. In cancer drug trials, both Black and Hispanic Americans are less likely to be enrolled than white Americans. Black people made up just 7% of participants between 2014-2018, leading to a lack of understanding of how many new cancer drugs work in Black patients. Even in cancers such as multiple myeloma where Black Americans are twice as likely to be diagnosed as white Americans, cancer drug trial participation is often very low, underscoring the importance of continued efforts to engage these populations to promote trial participation leading to more equitable health outcomes.

For both of these situations, detailed efficacy information as well as any rare side-effects or safety signals more common in racial minority Americans might only be seen in real-world data and evidence after the vaccine/drug has been approved for general use. This underlies the importance of continually tracking outcomes and effective communication of updated safety and efficacy information to communities who are under-represented in initial trials.

harmonizing data collection

vaccines may be less effective in people with comorbidities which disproportionately affect racial minorities

Another major consideration is comorbidities that could affect vaccine efficacy in some individuals. Both trials involved patients with comorbidities, for example around a third of participants in the Moderna trial3 had at least one other documented health condition.

Some of these diseases, such as diabetes are more common in Black Americans than white Americans, yet in the initial trials, the vaccines were only tested on small numbers of people who are both racialized and have other health conditions. This means that the efficacy and side-effects of vaccines in these populations is harder to calculate than for white Americans with comorbidities. As more people get vaccinated, targeted measures to collect data for racial minority Americans are warranted to continue to establish and maintain trust and counteract.

vaccine hesitancy
Medical Diabetes Check Device

establishing and maintaining trust to protect racial minorities throughout the pandemic and beyond

During clinical trials, adherence is closely monitored in a controlled environment, especially for chronic disease treatments such as diabetes or heart disease. While this tells one half of the story, this may not be entirely reflective of real-world practice and doesn’t paint an entirely accurate picture of patient behaviour. Forgetting to fill a prescription, unexpected adverse events, financial constraints, cultural beliefs and practices etc. all impact on patient behavior and can be factors in their reluctance to continue on a treatment plan or return for a follow-up appointment.

Taking these factors into account throughout future clinical research and drug development may help to drive adherence and promote stronger health equity moving forward. For example, it is likely that Covid-19 vaccines and boosters will be needed for several years to effectively protect people against the disease. Establishing a solid foundation of trust based on transparency and culturally sensitive communication, consistently updated with evidence gained from real world studies is vital for making sure racial minority populations in the U.S. continue to engage with Covid-19 vaccination programs. Successful implementation and maintenance of vaccine programs could facilitate greater trust in clinical trials for other diseases, ultimately leading to more equitable health outcomes for minority Americans.

chronic disease treatments
AEP marketing strategy

At CQ fluency, our mission is improving lives through health equity.

We specialize in empowering you with the most accurate clinical data and can partner with you to harness the power of RWE in your studies. Our team of subject matter experts can help you to develop an effective strategy that provides an in-depth assessment of real patient behaviors, ensures drug safety and compliance, and maximizes your reach to vulnerable populations through robust cultural insights.

Contact us today to learn how we can enhance your clinical research through RWE today.

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