Lack of diversity in clinical trials influences drug development 

Photo: Susan Morse

Diversity in clinical trials is lacking, according to Chris Boone, vice president, Global Head of Health Economics and Outcomes Research at Abbvie, a pharmaceutical and research development company.

Less than 16% people of color are in clinical trials, when 39% of the U.S. population is made up of people of color. An estimated 1% of Hispanic Americans are represented in clinical trials, and they are 16% of the population.

Moderna took heat for failing to recruit diverse volunteers for its COVID-19 vaccine, according to Boone, who spoke Tuesday at HIMSS21 for the session, "Big Data Matters in Big Pharma: A Look at Regulations, Ethics, and Innovation."

One reason for the lack of participation is logistical: 50 miles is the average distance a patient lives from the nearest clinical testing site. More than half who participate in one research study do not participate in another.

"Cultural, ethical, regulatory and financial concerns serve as significant barriers to progress," he said. "At the center is a lack of trust."

Most genomic studies are based on Eurocentric cohorts leading to worsening disparities, Boone said. Precision medicine is biased toward educated, socioeconomic groups.

The lack of diversity influences drug development. Precision medicine is tailored to differences in genes, environment and lifestyle. The results influence a public health perspective.

Recommendations to increase participation in trials that lead to drug development include making clinical trials part of a care option.

Real-world data holds the promise of closing the gap of clinical development and discovery, Boone said. Real-world data includes everything outside of a clinical trial.

The roadmap is to establish a shared vision for clinical practice and development, based on trust, collaboration and inclusion.

Finding new drugs is already difficult, Boone said. Less than 10% of therapies that enter human trials make it into the pharmacy.

Pharma development, said Boone, is a "risky business."

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com