“The way [medical] research is structured is really prohibitive” to participation by many underserved populations, and is a much bigger barrier to promoting diversity among volunteer patients than mistrust or reluctance, says Amy Knopf, an assistant professor in the Indiana University School of Nursing. She served on a 12-member National Academies of Science (NAS) committee which convened in December 2020 and recently produced the NAS Report “Improving Representation in Clinical Trials and Research.”
“There is a perception these populations are unwilling to participate in trials because of historical abuses” or other issues, but that doesn’t tell the entire story, Knopf says.
While she doesn’t intend to minimize past transgressions or wariness in some patient populations, Knopf believes infamous examples of unethical research aren’t the biggest factor slowing diversity in clinical trials. The issues, she says, are far more practical.
For example, at her own institution, they aren’t allowed to compensate patients with cash. “We can use gift cards,” but those aren’t always practical for some who either don’t have a bank account or access to the particular merchant, she notes.
Many institutional review boards (IRBs) overseeing trials have a “rigidity” when it comes to setting up compensation plans and in their overall approach to less affluent and more marginalized communities, Knopf says. She believes IRBs and others must be far more flexible and generous with their compensation plans, including their offers of day care, transportation, and other practical matters that are otherwise discouraging greater clinical trial participation.
“Patients in these populations are [generally] just as willing to participate in clinical trials” as those in more affluent populations, Knopf says, but they require different kinds of support. “Our report found these so-called ‘hard to reach’ populations” are in fact open to getting involved in clinical trials if they can make it work in their day-to-days lives, she adds.
“We have to support” more underserved populations if industry is serious about expanding clinical trial diversity, Knopf says.
Author: Michael Causey