The clinical trial industry must proactively address a record of “historical errors and misbehavior” in its treatment of minority populations if it wants to rebuild trust and increase patient involvement, says Dr. Harsha Rajasimha of Jeeva Informatics.
He notes that, as of late September, 77% of the total adult population of the U.S. had received at least one dose of a COVID-19 vaccine. Black and Hispanic people, however, remain less likely than whites to have received a vaccine, leaving them at increased risk of infection, particularly as the novel variant spreads.
Some of this hesitance to vaccination, notes Rajasimha, is rooted in long-lost trust. “We see it in clinical trials as well,” he says. “Black and brown people need the medicines and therapies being developed but are less inclined to trust the professionals who develop them.”
However, the issue of trust goes beyond skin color, Rajasimha says. “We need to look at how we treat patients, what we tell them, how we communicate, [and how we ensure that] we take the time to conduct thorough informed consent procedures,” he explains. “Patients often don’t know what to ask, and the onus is on the clinical trial professional” to ensure the patient fully understands the trial and its demands, he stresses.
“Prospective clinical trial participants need to understand as clearly as possible what they are consenting to, what the risks might be, and how the potential results will benefit mankind,” he adds.
“For fear and mistrust to be dispelled,” says Dr. Sharlene Brown, director of business development for Jeeva Informatics, “it is incumbent upon research organizations and government representatives to acknowledge the reality underlying previously under-represented populations’ concerns. Unfortunately, people have not atoned for what they have done, not apologized, or even admitted to the existence of a problem. The onus has been placed on the disenfranchised to correct the issue, which makes no sense.”
The organizers of clinical trials, Brown says, need to be educated on how to approach, recruit, and retain participants. The educational curriculum for these professionals should include strategies to overcome linguistic and cultural barriers that stand in the path of inclusion and decentralization of clinical trials.
Rajasimha also calls for a larger regulatory footprint to enforce diversity goals. The U.S. Food and Drug Administration and others “have encouraged diversity, but we’ve seen no real mandate,” he says.
The Declaration of Helsinki and the Belmont Report—documents that establish medical ethics in clinical trials—may need to be revised or more multinational declarations may be required to help overcome some of the mistrust in global clinical trials, Rajasimha suggests. Certification providers such as the Association of Clinical Research Professionals can consider upgrading their curricula to include decentralized clinical trial methods for improving diversity, equity, and inclusion in clinical research, he adds.
Author: Michael Causey