Making Clinical Trials Work for Everyone

When it comes to finding new treatments for multiple myeloma (and cancer in general), clinical trials are essential. But, clinical trials must include people from all backgrounds to make sure the treatments work for everyone. New therapies should prove they are equally effective and safe across ethnicities, ages, and genders. Right now, that's not happening as often as it should.

It Starts with Enrollment: The Numbers Tell a Story 

Let's talk about representation. While Black Americans make up about 20% of myeloma patients in the United States, only 4-5% of people in FDA-approved clinical trials are Black. This gap matters because it affects how well we understand how treatments work for our community.

The story is similar for Hispanic Americans, who represent about 8% of myeloma patients but only 1-2% of trial participants. And our older community members, who are more likely to develop myeloma, are often left out too – especially those over 85.

Hidden Barriers in Trial Design

Sometimes, the way trials are designed unintentionally keeps people out. Here's a perfect example: Many Black people naturally have lower neutrophil counts due to something called the Duffy Null Phenotype. This is completely normal and healthy – in fact, about two-thirds of people with African ancestry have this trait.

But here's the problem: many clinical trials require higher neutrophil levels without considering these natural differences. It's like having a "one-size-fits-all" approach in a world where we know one size doesn't fit all.

In short, Black and Hispanic patients are more likely to be excluded from clinical trials because the medical criteria used to determine eligibility for clinical trials—specifically related to blood (hematologic) measurements—are too strict and don’t account for natural variations found in these groups.

Making Positive Changes 

The good news? Healthcare leaders like Dr. Craig Cole are working to change this. You can watch the video below or read on to learn more about what can be done to include more people, especially those experiencing biases, exclusions, or disparities, below. 

Updating Trial Requirements

To avoid accidental exclusions, trial criteria should be reviewed and revised to adjust to a wider range of blood counts, allowing more people to be able to join clinical trials regardless of race or ethnicity. Thankfully, there are some clinical trials making these types of changes to be more inclusive. 

Bringing Trials to Our Communities

Clinical trials are typically available through academic treatment centers and are harder to access for those who live far away from bigger cities or who do not have access to transportation due to cost, public availability, physical challenges, or other barriers. 

One of Dr. Cole's and his team's proposed solutions was to bring trials to local communities and oncology centers that patients frequent, especially in underserved areas. 

“I think one of the most important things is to include patients in the design and implementation of clinical trials,” suggests Dr. Cole, “the only way we are going to cure myeloma is by making sure the drugs [we use] work for everyone.”

Taking Action

By addressing these barriers, the research community can better serve Black myeloma patients and provide more equitable access to potentially life-changing therapies.

Dr. Cole is passionate about increasing clinical trial participation in myeloma. Read this article to learn from him as he debunks myths you might have heard about clinical trials. 

If you're interested in clinical trials:

• Talk to your healthcare team about trials that might be right for you
• Ask questions about eligibility criteria and how they apply to you
• Consider joining the conversation about making trials more inclusive
• Share your experiences with others in our community

Join our Black Myeloma Health Community

Sources: 

• Key Statistics for Multiple Myeloma | American Cancer Society
• The Duffy blood group - Blood Groups and Red Cell Antigens - NCBI Bookshelf
• Analysis of racial and ethnic disparities in multiple myeloma US FDA drug approval trials | Blood Advances | American Society of Hematology
• Why are African Americans Underrepresented in Myeloma Clinical Trials?