Over the past year, media outlets have covered a number of stories on COVID-19 vaccine trial volunteers. These volunteers wanted to contribute to the development of a vaccine that could protect their loved ones. Many volunteers spoke out about at-risk family members.
COVID-19 has disproportionately affected people from racial and ethnic minority groups. Age, genetics, gender, and a number of other characteristics can lead to vastly different responses to the same disease — or vaccination — among people. This is why diverse populations need to be represented in clinical trials.
What is diversity and why is it important?
Race, ethnicity, gender, age, and geographic location are all aspects of diversity. Even socioeconomic status can affect which populations are impacted the most by a disease. In some cases, different races and ethnicities require different dosages of certain medications. Differences in gender and age can also affect ideal dosage amounts.
Diversity in clinical trials and representation of all populations impacted by a condition or disease is crucial to the development of effective preventative medicines and treatments. This is why the U.S. Food and Drug Administration (FDA) requires that the demographic mix of volunteers in a clinical trial must represent the broader population for the results to be applied to the general population.
Why is it difficult to recruit diverse populations?
Among all populations, the most common questions about trials usually regard time commitments and compensation, along with the potential risks and benefits of participation.. In addition to these concerns, some groups may mistrust the research process due to historical exploitations, such as the Tuskegee Experiment.
Although clinical trials now follow strict ethical policies, and the informed consent process ensures participants fully understand all aspects of a clinical trial, mistrust and caution still exist for certain populations. In a recent article, Asefa Mekonnen, MD, Velocity principal investigator in Rockville, MD, articulated this struggle between the need for widespread COVID-19 vaccination among populations who have been subject to past injustice.
What can be done to achieve proportionate representation in clinical trials?
First and foremost, it requires the companies involved in clinical research — companies like Velocity — to recognize these sensitive issues and educate staff on cultural perceptions. Potential participants should always be comfortable to ask clinical staff questions about studies they are interested in. Nothing is off limits. Additionally, participants can always talk to their doctors about the risks and benefits of a trial before participating.
Throughout the COVID-19 pandemic, Velocity also connected with community leaders and advocacy groups to provide resources and information about COVID-19 vaccine trials. One silver lining of COVID-19 is that more people than ever were interested in what it takes to create, research, and develop a vaccine. As always, we encourage anyone to contact Velocity for more information about specific clinical trials, or the clinical research process in general — we’re happy to answer any questions regardless of whether or not you participate in a study.
Diverse representation in clinical trials is crucial for the health and safety of the general population. Velocity’s clinical trials are held to incredibly high standards set by the FDA and Velocity.