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Another key opportunity is to develop clear messaging about potential vaccines such as addressing the research and clinical trial process, the timelines that are reasonable, and the paramount importance of safe and effective vaccines for COVID-19. Recent surveys have found that nearly half of Americans polled are hesitant to take the vaccine once it is approved for use (https://bit.ly/2AWPIx7).
The biopharmaceutical industry also has a distinct role to prioritize health literacy and incorporate the patient voice. While public perceptions and understanding of the industry vary widely, the industry can benefit from
adopting health literacy principles that address the aspects of vaccine development, timelines, safety, and efficacy. A deliberate effort to ensure the highest comprehension across diverse populations may enhance trust between society and the healthcare sector, lead to greater acceptance
and uptake of approved vaccines, and result in a slowing of the virus transmission across the globe.
Bringing Patients into the Process
The opportunity before us is to
seek out and listen to patient voices throughout the clinical development process, and to support health literate information and communications
that take place between patients and their health providers once vaccines and treatments receive the U.S.
Food and Drug Administration’s (FDA) approval. By including
patient experiences and preferences throughout the concept, development, approval, and reporting processes, we have the ability to show respect to our end users, better understand how to safely use these potential products, improve understanding of the research and clinical trial processes, and increase more diverse participation in clinical trials.
Special attention to engaging
diverse populations—the elderly, un/ underinsured, vulnerable populations, those at higher risk of poor outcomes,
individuals who speak English as a second language, etc.—is crucial and will ensure that the industry incorporates insights and lessons learned from a broad and real-world representation
of our societies. If we do a better job recruiting diverse populations, we will have a clearer understanding of how medicines and vaccines may have a different safety and efficacy profile for people of Black, Hispanic, or Asian descent, for instance.
The FDA recognizes the importance of incorporating the patient perspective and experience into the clinical trial process. The FDA has conducted listening sessions for more than 20 disease areas and established a Patient Engage Collaborative (https://bit. ly/3gWWsul). Other efforts at the FDA include a Patient-Focused Drug Development initiative (https://bit. ly/2AVCCQK).
The Impact of Engaging Diverse Communities
While progress has been made, much work is still to be done. That starts with ensuring participants in clinical trials represent those who make
up society—and explicitly include under-represented and vulnerable populations. This means reaching out in respectful ways to patients with the lowest health literacy and who often experience the greatest sense of disempowerment.
A deliberate effort to ensure the highest comprehension across diverse populations may enhance trust between society and the healthcare sector, lead to greater acceptance and uptake of approved vaccines, and result in a slowing of the virus transmission across the globe.
September 2020 / pm360 magazine 31
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