Racial and ethnic minorities have historically been underrepresented in clinical research. In 2011, according to a study published by Clark et. al., it was shown that African Americans and Hispanics made up 5% and 1% of clinical trial participants. Yet, African Americans and Hispanics make up 12% and 16% of the population. Moreover, with several drugs such as beta-agonists like Albuterol, hypertensive medications and other classes of drugs, there are differences in response to therapy when comparing African Americans and Hispanics versus their Caucasian counterparts. Medical affairs plays a particularly important role in data generation once a drug or device has been approved for use in the general population. In particular, medical affairs will usually oversee drug safety, publication planning, phase IV studies, and investigator initiated studies.

Why is there a diversity & inclusion gap?

There are several barriers which may contribute to the inclusion gap in clinical trial research. One may be a mistrust by minority populations of the healthcare system. Another may be lack of awareness and information about clinical trials. Finally, another could be obstacles related time and resources that are associated with increased clinical trial participation. On the other side of the coin is a gap in cultural competency and knowledge among healthcare providers and scientific researchers. A study published in the Journal of Current Problems in Cardiology (2019) by Clark et.al, found that patients were most concerned that healthcare providers would not closely monitor their health status and treatment protocols- resulting from a mistrust of ‘the system.’

Community Outreach & Medical Science Liaisons

Traditionally, medical science liaisons (MSLs) have been focused on key opinion leaders (KOLs). These are typically thought leader physicians and researchers in a particular therapeutic area. However, there exists an opportunity for MSLs to conduct outreach to communities which may benefit from knowing about clinical trials in their local area. For example, several pharmaceutical manufacturers which produce HIV drugs conduct interactions with prisons where the rate of HIV is disproportionately higher. Another example is in the rare disease community where often times pharmaceutical companies struggle to find patients. MSLs may attend these rare disease patient advocacy events. However, for broader, more chronic diseases like heart disease, cancer, asthma and neurological disorders, the opportunity to create greater awareness in a more diverse community can be facilitated by the organizations which represent a voice for these patients such as the American Heart Association, the American Society for Clinical Oncology (ASCO) and more.

Rethinking what it means to be a KOL?

Our traditional definition of a KOL needs to evolve if we want to be more inclusive in clinical trial research. There are several ways that medical affairs can play a role in accomplishing this goal. One is to rethink our definition of a KOL. We need to increase our focus on a wider array of stakeholders such as regulators, community leaders, diverse physician groups, and leveraging social media to create greater awareness among a broader population. MSLs and medical affairs leaders need to think about incorporating social listening and sentiment tools to understand which digital KOLs have an impactful voice and in which communities that voice resonates.

Moving in the right direction

Several companies, such as Pfizer, are stepping up and paying more attention to this matter as can be seen here on their website where Pfizer addresses diversity in clinical trials. The Accreditation Council for Medical Affairs (ACMA) offers a course on diversity in clinical trials where the participant receives a certificate. The COVID-19 pandemic has heightened awareness around the need for greater diversity of ethnicities and races in clinical trials. Indeed, the pandemic reveals a striking disparity among the different socioeconomic classes in the United States. The role that medical affairs plays in ensuring that all patients’ voice is heard is of paramount importance if we are to ensure that drugs are effective and safe not only for a specific part of the population but generalizable as much as is possible to everyone.