SubjectWell eyes diversity in COVID-19 vaccine trials

Austin, Texas-based SubjectWell reports it is working with pharmaceutical firms to enlist patients for a number of Phase II and Phase III COVID-19 trials. What’s more, the company reports of the 10,000 patients it is connecting to these trials each month, about 40% of them are Black, Latino or Native American.

Ivor Clarke, CEO of SubjectWell, told Outsourcing-Pharma that obtaining a diverse patient population is important in most trials, but it is particularly crucial with the virus.

“The coronavirus has disproportionately affected racial and ethnic minority communities, with COVID-19 infection rates among African Americans approximately five times that of Caucasians​,” Clarke told us. “The industry has to consider the disease’s real-world impact as it races to develop a safe and effective vaccine to make sure it's safe and effective for truly everyone​.”

The best way to ensure the vaccine is safe and effective for all patients, he added, is to make sure trials recruit a representative population.

“Lack of representation in clinical trials has been a consistent industry issue, with minorities making up fewer than 10% of trial participants on average. So as we witness how COVID-19 is impacting minority communities, it is the industry's responsibility to make some real changes,​” he explained.

However, Clarke pointed out, patients from certain demographics may view trial participation less favorably than people from other backgrounds. SubjectWell recently completed a survey in partnership with the Center for Information and Study on Clinical Research Participation​, revealing that a potential recruit’s attitudes toward trial participation tends to vary depending on race and gender.

“During the pandemic, African American patients reported more hesitations when considering participation in non-COVID-19 clinical trials and a greater desire for safety precautions if they were to participate compared to Caucasian patients​,” Clarke explained. “Taking a closer look, 26% of African Americans responded that they are not at all likely to consider participation in a clinical trial for a medical condition other than COVID-19, as compared to 13% of Caucasians​.”

“What this tells us is that sites and sponsors across the industry have to put precautions in place to ease patient hesitation, especially in populations disproportionately affected by the pandemic,​” he added.

By offering access to millions of potential patients, SubjectWell aims to help researchers dramatically accelerate last patient in (LPI), and address the lack of diversity in COVID-19 clinical research. Clarke commented that he is positive the current pandemic could contain a silver lining: improved representation in patient recruitment.

“This is hopefully a turning point for racial diversity in clinical research. By recognizing the altitudinal differences between racial groups, as an industry, we can use this once-in-a-lifetime event to address diversity in clinical trials through patient-centric improvements, helping build trust across racial minorities in clinical research and healthcare in general​,” he said.