The Food and Drug Administration (FDA) has released draft guidelines on how drug and medical device developers can improve diversity in their clinical trials. Under these guidelines, developers seeking FDA approval should create a plan with specific goals for patient recruitment, as well as strategies to achieve the goals.
It is important to understand that diversity in clinical trials is not just a matter of properly reflecting diverse communities, although that is certainly appropriate; in fact, diversity impacts how well the trial reflects both the efficacy and safety of the drug. A clinical trial seeks to determine how well a drug works and the likelihood of side effects. But the nature of those effects can vary between audiences for biological and environmental factors. For example, African American autoimmune patients respond differently to drugs than White autoimmune patients. Studies show that women – historically underrepresented in clinical trials - are more likely to suffer some adverse side effects.
In recent years there have been improvements in clinical trial diversity, but we have a long way to go. In the 1990’s, 92% of trial participants were White; decreased to 75% in 2020 with 8% Black, 11% Hispanic, and 6% Asian. Cancer trials are less diverse still. Of the 8,700 people who participated in trials for cancer drugs approved by the FDA in recent years, only 4% were Black.
If diversity in trials is important in determining efficacy and safety, why don’t companies just recruit the right groups of people? Myriad structural and behavioral barriers remain, including lack of accessible trial sites, historical violation of trust, and a general lack of healthcare coordination.
The Colorectal Cancer Alliance strongly supports the FDA taking proactive steps to improve diversity and will provide comments to help strengthen the guidelines prior to finalization, including emphasis on:
- Expectations for how companies work collaboratively with communities, without increased pressure or transactional relationships.
- Close collaboration with patient advocacy groups to reach patient authentically and without burden.
- More detail in the guidance around important considerations, such as reimbursement and language.
- Guidelines around how to create a long-term, sustainable approach to building trust and changing perception of trials, leading to equitable participation and access.
The action the FDA is taking is by no means the full solution, but it is a step in the right direction. A problem cannot be solved until it is recognized as such, and plans are put in place to solve it. If you would like to read the FDA draft, it is available here.
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