A blog post by Clinical Research Pathways Executive Director Marjorie A. Speers, Ph.D.
In June, the Food and Drug Administration (FDA) released draft guidance on enhancing the diversity of clinical trial populations. As part of the guidance development process, FDA also issued the customary invitation to submit comments in preparation for the final guidance document. Some 90 individuals and organizations responded, including Clinical Research Pathways.
The deadline to comment has passed, but that doesn’t mean it’s time to be silent.
We must continue to advocate for FDA to do more to increase diversity in clinical research—to elevate its efforts and set an example. Researchers, drug and device developers, and others involved in clinical trials all look to FDA. If FDA supports and promotes diversity in clinical research, others will follow suit.
The proposed FDA guidance is moving in the right direction. As we note in our comments, Clinical Research Pathways agrees with FDA recommendations that companies use best practices to create the broadest possible inclusion criteria for clinical trial enrollment.
It is important to note, however, that much of the draft guidance focuses on easing inclusion criteria to expand the existing patient base. That falls short of making sure that clinical trials include patients of different races, ethnicities, ages, and genders.
Therefore, we are recommending that FDA be more explicit and refer specifically to racial, ethnic, age, and gender diversity throughout the guidance document. Furthermore, we are asking FDA to encourage researchers to enroll underrepresented populations at the start of a trial instead of adding them at a later date.
Diseases affect members of all populations, and drug development must take that into account. Currently, for example, African Americans make up 13.4% of the U.S. population but only 5% of clinical trial participants. Many companies are responding to these inequities by seeking ways to increase diversity in clinical research. We encourage them and FDA to accelerate these efforts and, ultimately, ensure that clinical trial populations reflect those of the population as a whole.
Please join us in advocating on behalf of those who are underrepresented in clinical research.