Beyond technology, awareness, and access—cultural competence is key.
In clinical research, investigators collect data from a representative selection of participants. That data is then generalized to apply to the larger population. But the demographics of participants in clinical trials are skewed in comparison to any given population. For example, although Black Americans make up about 13% of the U.S. population, Latinos about 18%, and Asians more than 5%, those demographics aren’t reflected in clinical research. The FDA reports that only 5% of clinical trial participants are Black, fewer than 2% are Asian, and fewer than 1% are Latino. And it’s not only race; women and seniors, for example, are also poorly represented.
The lack of diversity isn’t just a moral issue—it’s an issue that has scientific and global health implications. The long-standing systemic health and social inequities that result in uneven representation in clinical research mean that today’s medicines may not be equally safe and effective for all populations, leading to a health equity chasm that must be addressed.
Finding a solution isn’t easy. One hurdle to correcting the problem is determining what the disparity is in the first place: In a study published in JAMA Oncology, of the 230 oncology clinical drug trials between 2008–2018 that resulted in approved cancer drugs, only half included any information about the participant’s race. And of those that did report, the breakdown was vaguely defined.
Christian Rubio, vice president of strategic advancement at Global Genes, the rare disease patient advocacy organization, and Scott Schliebner, senior vice president of the Center for Rare Diseases at PRA Health Sciences, recently had a conversation tackling questions about the implications of the lack of diversity in clinical trials, how that impacts health equity, and how cultural competence can help close the gap.
Scott: We need to make proactive investments in understanding and building trust in various communities, find a unified approach, and keep asking ourselves what we can do to reform this system.
Christian: We need to embrace the fact that all of us in this industry need to play our part. Everyone can start in their own circle. Look at your own community. Ask questions, seek new people to talk to and get perspectives. If someone knows a lot about an underserved community, even if they’re not in your therapeutic area, you’re going to learn a lot talking to them.
Researchers need to take personal responsibility for growth and awareness and ask questions of new people. That takes bravery. You have to know you’re going to come across as naïve, but that’s okay. That’s how you learn.
Scott: To build trust within underserved communities, come in asking how you can help. Ask how you can learn. Even flat out ask, “What can I do to learn from you?” That’s a great way to start—these communities know more about themselves than we can even grasp.
Christian: Develop your cultural competence as an individual and then apply that to your research work. We have to ask ourselves the tough questions about our work environments, too. Is our research team diverse in ethnicity, academic pedigree, and home community experience? Do we hear their experiences in our internal discussions? Do their experiences and backgrounds get incorporated to foster better connections with community leaders? Is that valued by leadership? When we demonstrate openness by asking questions, we show our willingness to challenge our assumptions inside and outside the research conversation, and that builds trust with better engagement as the metric. That’s how we’ll close the gap in diversity in clinical research. It won’t come quickly, but we have to start.