In the world of medicine, the one-size-fits-all approach is a myth. Medicines impact people differently, and this is why inclusivity is crucial in clinical trials. On April 13, 2022, the Food and Drug Administration (FDA) issued guidance around clinical trial recruitment, emphasizing the need to enroll more participants from underrepresented racial and ethnic populations.1 This move by the FDA was a reaffirmation of the unfortunate reality that racial and ethnic minorities remain underrepresented in present-day biomedical research.
Clinical trials, and the brave volunteers who participate in them, are the backbone of developing safe and effective treatments to combat disease and illness. One such advocate for health equity in clinical trials is Shemika Austin, a Senior Clinical Trials Manager at Novo Nordisk.
Shemika's journey into clinical research was unexpected, but it has been a transformative experience. She has been with Novo Nordisk for over nine years, starting her career in the rare disease clinical research space before being promoted to a clinical trial manager. This journey has given her a profound understanding of the process of getting a drug to market and the importance of diverse recruitment in clinical trials.
Ensuring a clinical trial is representative of all communities is a task Shemika takes seriously. She believes in the power of education and advocacy. In a recent trial she supported, which was for a therapeutic area that impacts more than 50% of Black Americans, her team used data analytics to increase diversity. They revised the feasibility questionnaire sites completed before being accepted to the trial, ensuring it was applicable to all patient populations and free from any bias that could skew the trial’s outcome.
Addressing barriers that prevent certain patient populations from applying was another challenge. The team identified several obstacles, such as clinical mistrust, language barriers, and a lack of representation among physicians. To overcome these, they established new external partnerships and collaborated with organizations like Black Health Matters and Fingerpaint to create culturally relevant patient materials for recruitment.
At Novo Nordisk, the belief is that increasing diversity in clinical trials is a part of health equity. Medicines work differently for different people, and it is crucial that clinical trials represent the real-world experience of the patients they aim to treat. The goal is to ensure that all healthcare professionals can provide safe and effective treatments for their patients.
Shemika's hope for the future is that the conversation around diversity in clinical trials continues and that similar strides are made across the industry. She dreams of expanding access to clinical trials in regions like the Caribbean and parts of Africa where they are needed. In the fight against disease and illness, clinical trial diversity is not just a buzzword, but a necessity. It is through the tireless efforts of advocates like Shemika Austin that we can hope for a future where health equity is not just a goal, but a reality.
FDA Takes Important Steps to Increase Racial and Ethnic Diversity in Clinical Trials. April 13, 2022; Available from: https://www.fda.gov/news-events/press-announcements/fda-takes-important-steps-increase-racial-and-ethnic-diversity-clinical-trials.