Today is the Elimination of Racial Discrimination Day, and I want to reflect on a few articles published recently discussing racial and ethnic representation in US Clinical Trials as well as the FDA action plan created in 2015.
The US trial participation data reported by the FDA doesn’t represent the US population, as evidenced by this report. Black patients, who comprise 17% of the population, only represent about 4% of study participants for many disease areas included in FDA reports. Not only this is an issue of representation, but it also makes it difficult to understand the actual effectiveness and safety for this population.
Clinical trial diversity is many different things. It includes, but is not limited to, a variety of different races/ ethnicities, gender, and ages in clinical trials. Inclusion of these characteristics helps sponsors determine if their products are appropriate to specific groups of people.
The lack of diversity in clinical trials can be a cause for concern. When generalizing findings, a study runs the risk of making assumptions about the product safety and effectiveness that may not be accurate for a specific population. For example, research has shown that people from different ethnic groups could react differently to the same medicine. A clinical trial that includes a diverse group of participants could help researchers see if these differences exist and measure their impact.
To overcome this issue, in 2015, the agency launched an action plan aimed to improve the representation of racial minorities in clinical trials. Their plan called for many improvements to the transparency, including enhanced reporting and demographic factors that would be included in the drug trials snapshot.
Furthermore, FDA recommendations encourage sponsors to implement strategies to reduce barriers to participation for potential participants:
- Broadening inclusion criteria using Enrichment Strategies
- Be mindful of the trial design and its methodological approaches.
- Use inclusive Trial Practices such as the inclusion of Clinically Relevant Populations.
I encourage you to review these two articles that examine where we stand today:
The first article assessed whether there has been any improvement in these trends over time, while the second focused on providing recommendations for improving racial and ethnic diversity in clinical trials.
The FDA is making some big changes to the way they report clinical trials, and the agency’s dashboard is the first step towards improving the transparency of racial and ethnic data in clinical trials.
In November 2020, the FDA issued this guide that you might find helpful when thinking about enhancing the diversity in Clinical Trials.
