Diversity Issues Hinder Clinical Trial Efficacy, Data Value

The COVID-19 pandemic “exposed severe disparities in our healthcare system,” including the relative lack of diversity in the clinical trial patient population, Bashar Shihabuddin, MD, MS, a professor of emergency medicine at Nationwide Children’s Hospital, told attendees of a recent ACRP webinar.

“This disparity affects minority populations negatively” and disproportionally, Shihabuddin said, adding that trials for Pfizer and Moderna vaccines featured a patient population that was more than 70% white. “Unfortunately, these results are not unprecedented,” he said, pointing out that similar diversity problems exist in a wide swath of clinical trial study areas, especially cancer and cardiovascular research. Among other downsides, lack of diversity weakens the science behind the trials and dilutes data value, experts generally agree.

A root cause of the problem is the lack of diversity among the principal investigator (PI) population, Shihabuddin said. While that issue is relatively acknowledged in industry, he called on industry not to forget that the same lack of diversity among the clinical research coordinator (CRC) population is also a negative factor in terms of widening the clinical trials patient inclusion tent. “CRCs are involved closely in patient recruitment, informed consent, and follow-up,” he noted.

Language and other cultural barriers are also likely obstacles, according to a recent survey of more than 50 CRCs in a pediatric research network conducted by Nationwide Children’s Hospital. For example, more than 80% of the CRCs who spoke Spanish said it helped them attain more success retaining patients.

The survey also found some female professionals felt they were at a disadvantage during the conduct of a clinical trial. Calling it an “alarming finding,” Jessica Fritter, MACPR, ACRP-CP, a clinical research administration manager at Nationwide Children’s Hospital, said more must be done to address the problem. “Our survey shows how challenging it can be for women to feel included in a research team,” she said.

Fritter cited two responses from the survey as troubling evidence of the problem:

  • “As a female, I sometimes feel as though I am treated differently than my male counterparts both in rooms and working within the research team.”
  • “I believe my gender, as a female, hinders my job due to my experiences with my male counterparts. I’ve seen the differences in the way patients/families interact with male CRCs when they approach for consent versus when I approach for consent. It seems to be that they trust my male counterparts more and are more willing to do studies with male CRCs.”

Shihabuddin called on industry to learn from its past mistakes and raise the bar on both diversity and addressing cultural differences. “We need to learn from our experiences and ask subjects what worked and what didn’t for those who opted in and those who opted out of a study,” he said. “It’s about building authentic relationships by listening and learning” from each other, he added.

“ACRP has taken the reins” to help evaluate cultural competency in the workforce through a working group, Fritter told attendees, with an objective to evaluate existing resources for clinical research professionals “and identify how to best make those more accessible and actionable for key roles,” including PIs, CRCs, and clinical research associates. She praised the efforts of the working group as it also focuses on organizational effectiveness and engagement on the value of diversity, equity, and inclusion as an important step forward.

A replay of the webinar on “Diversity of Research Personnel: Knowing Who We Are to Know Who We Serve” is available free for ACRP members.

Author: Michael Causey