The clinical trial workforce’s incredible response to the COVID-19 pandemic has generated some of the most positive media coverage and public acclaim the drug and device research and development industry has ever seen.
Whether it was salvaging important trials by pivoting to a more decentralized approach or launching COVID-19 vaccine trials in a matter of weeks or even days, the clinical research enterprise rose to the challenge and earned the respect of wide swaths of the population by developing several effective vaccines at warp speed.
“We need to harness that public awareness,” says Elisa Hurley, PhD, executive director of Public Responsibility in Medicine and Research (PRIM&R). She’s calling on industry to amplify “trusted sources” to make trials more “transparent” and “the research and science enterprise even more trustworthy.”
However, the brighter spotlight on clinical trials for the past two years doesn’t come without a cost, Hurley notes. “We are up against huge levels of mis- and disinformation,” and the industry must confront it head on to assure the public that clinical trials operate with solid integrity and high ethics, especially in areas of electronic informed consent, and “how [patient] data are collected and used,” Hurley says.
She’s also a big fan of increased used of hybrid or decentralized clinical trials (DCTs) to make it easier for everyone to participate. “We have a diversity and inclusion problem” in the clinical trial industry, and leveraging elements of DCTs can make an important dent in it, she says.
“It can be prohibitive for many to participate in clinical trials” that require multiple visits to investigators and their staff at traditional study sites, Hurley notes. Obstacles can include distance, time commitment without getting time off from work, and the challenges of juggling child or eldercare. “We can better use technology to bring trials to patients,” she says. “It’s an exciting time.”
She also calls on regulatory authorities to develop guidances better spelling out how the tenets of DCTs and trials with hybrid onsite/offsite components can be applied to the conduct of studies. Institutional review boards are flexible working within the current regulatory framework, Hurley notes, but she adds that regulators can help better define and expand usage if they spell out their expectations.
“We’ve learned a lot in the last two years” about how to increase clinical trial inclusion, Hurley says. “Now, we have to do a better job of educating [the public] and make the entire enterprise more trustworthy” in their eyes, she stresses.
Author: Michael Causey