In the U.S., Black Americans are three times more likely to die from asthma than whites. There are a number of complex factors that play into this disparity, but one likely contributing factor is that albuterol, the most commonly prescribed asthma drug in the world, doesn’t work on many people of African descent.
This is just one of many examples of healthcare interventions that work differently on people with different genetic backgrounds from white Americans. Warfarin, the most commonly used anticoagulant drug, puts many Asian Americans at risk of bleeding due to increased sensitivity to it. Most Pacific Islanders have a genetic trait that makes them less responsive to the blood thinner clopidogrel, meaning they’re at higher risk of repeat heart attacks. The list goes on.
Why are so many drugs that are ineffective for large groups of people commonly prescribed? Again, several factors are at play. But first among them is a lack of diversity in most clinical research. Historically, most clinical trials have been conducted on primarily white participants. The health outcomes of communities of color have suffered as a result.
In recent years, more attention has been given to this issue, and many pharmaceutical companies are adjusting the way they conduct clinical research in response. While the systemic barriers to diverse clinical research are significant, there is much more that pharmaceutical companies can do to overcome them.
Approximately three-quarters of all clinical research participants are white, according to the FDA’s 2020 Drug Trials Snapshots Report. By contrast, only 11% are of Hispanic descent and 8% are of African descent.
This is out of step with America’s actual racial makeup, which is approximately 59% white, 19% Hispanic or Latino, and 13% Black or African American.
The disproportionately low representation of people of color in clinical research puts patients at higher risk of being prescribed drugs that aren’t compatible with their genetics. It also reinforces patterns of structural racism and fails to address social determinants of health (SDOH), contributing to overall worse healthcare outcomes faced by minority populations in the U.S.
The FDA has taken notice of the importance of diversity in healthcare for accurate clinical research. In 2022, it released guidance on how pharmaceutical companies can promote diversity among research participants. The FDA is requiring companies to submit a diversity plan, and if appropriate efforts aren’t taken, companies risk a delay or denial of drug approvals, as well as potentially being required to perform additional studies.
It’s true that there are several historic barriers that make it more difficult to recruit research participants from communities of color. However, pharmaceutical researchers have many opportunities to break down these barriers and, in the process, demonstrate their leadership in the industry.
The pharmaceutical industry can influence diversity in healthcare in numerous ways, beginning with hiring practices that promote a more diverse workforce. Research shows that promoting diversity in the workplace helps to better represent the tapestry of our communities as it relates to race/ethnicity, gender, sexual orientation, immigration status, physical disability status, and socioeconomic level to render the best possible care to our diverse patient populations.
From that foundation, pharmaceutical companies can translate diverse experiences more effectively to promote diverse, inclusive, and accurate clinical research with a targeted strategy that involves community partnerships and compassionate outreach. Here are five things researchers can do to increase diversity among their clinical trial participants.
Forming partnerships with organizations that are closely involved with communities of color is one of the best ways to grow diversity in clinical research, according to a report from Deloitte.
Pharmaceutical researchers can work with community support organizations, academic institutions connected to communities of color, such as historically black colleges or universities (HBCUs), federally qualified health centers (FQHCs), and similar groups to learn more about a community and to find effective ways to connect with them. The experts at these organizations can also help researchers learn more about a community and what kind of outreach they’ll respond to.
Often, connecting with community organizations puts you in contact with patient advocates. These are community leaders, medical professionals, and other individuals who understand the importance of diversity in healthcare and are influential in communities of color. As trusted members of these communities, they can explain community members’ concerns about participating in clinical research, help you address those concerns, and advocate to potential participants on your organization’s behalf.
Many people from underserved communities may not know what participating in clinical research means or understand why they should bother. Creating educational materials for communities of color can help bridge these knowledge gaps. It helps to write these materials in a clear, straightforward manner and in the languages most often spoken by the communities you’re trying to reach.
The logistics of participating in clinical research are often difficult for members of underserved communities to navigate. They may have difficulty accessing your location, be unable to take time off work, or face challenges finding childcare. Researchers can provide support services that help people overcome these challenges. These could include transportation to your location, flexible scheduling, childcare, fair compensation, and more.
Gathering demographic data and reporting on it is essential to making sure you are hitting your diversity targets and following the FDA diversity plan, as well as meeting the FDA’s new data collection guidelines. That data can also help you assess the success of your efforts and find ways to improve them in the future. Finally, transparently reporting on diversity data is beneficial to the pharmaceutical industry at large, potentially establishing you as a leader in diverse research that others can follow.
Historically, the importance of diversity in healthcare was an afterthought for pharmaceutical companies, leading to inaccurate research and worse overall health outcomes. But these trends are now being reversed, and pharmaceutical researchers can be on the front lines of that change.
Boost inclusivity in trials faster and for the long term by zeroing in on the populations you lack. Acclinate works with over 100,000 members of NOWINCLUDED to build real relationships by cultivating trust, fostering knowledge, and empowering communities and people of color with information about relevant health conditions. By engaging with community leaders and influencers, NOWINCLUDED sparks participation in research opportunities and provides vital support for patient groups.
This kind of access helps facilitate engagement around your trials, and then Acclinate’s predictive analytics technology evaluates the data generated to forecast where and when your next effort should happen to create the ongoing representation you need. To learn more, schedule a 1:1 Meeting.