Studies show most potential participants learn about clinical trial opportunities from a personal physician or family member. Unfortunately, that model has made it stubbornly difficult for regulators, sponsors, and others to expand clinical trial patient populations into relatively underserved minority communities.
“We still have a pretty significant challenge ahead of us” when confronting the problem, says R’Kes D. Starling, RPh, MBA, founder and chief executive officer of Reveles Clinical Services.
Scheduled to hit the market next spring, Reveles will be a patient-centric, purposeful, technology-enabled clinical research support company specializing in patients with rare and complex diseases who are unable to participate in traditional clinical trials. Reveles’ integrated technologies and direct-to-patient/decentralized trial support will enable patients to participate remotely.
However, technology and tactics will only take us so far in the effort, Starling says. The clinical trial industry has to do a better job of educating the public and healthcare professionals about the efficacy, safety, and importance of clinical trials in the drive to bring new products to market, he adds.
“We need to address it with education and better access,” Starling says. For example, there are far too few minority principal investigators (PIs) currently active in the clinical trial space. “They fear the administrative burden, and don’t think they have the time to become a PI,” he says.
Starling is active with a group called Black Men in White Coats, which is dedicated to increasing the number of minority physicians in the United States. “We need to invest and focus attention” on it,” he says.
Trust is also a core component to securing more participation from a wider swath of the patient population. “There are historical accounts that warrant” skepticism among minority communities regarding bad treatment in clinical trials, Starling noted.
The problem isn’t going to go away. Far from it, in fact, according to Starling. With the advent of personalized medicine, biomarkers and the like, it will only become more crucial for clinical trials to represent the complete patient population, he stressed.
The U.S. Food and Drug Administration has been vocal about tackling the challenge. Most recently, it released a public guidance for comment to encourage industry to weigh in on ways to extend the benefits of clinical trials to more people.
Author: Michael Causey