The “COVID-19 catalyst” may have sped adoption of remote monitoring, decentralized clinical trials (DCTs), and other related and patient-friendly innovations, but it shouldn’t have taken a pandemic to move the industry in that direction, says Libbi Rickenbacher, PhD, director of strategy at 4G Clinical.
“We should have already been there” as an industry, she says, extolling the virtues of hybrid (onsite/offsite) trials and DCTs as means to improve a trifecta of patient care, recruitment, and retention in clinical trials.
Further, Rickenbacher doesn’t see industry adoption of these trends reversing course even as the pandemic’s impact on clinical trial operations decreases. In fact, she expects hybrid adoption to continue its increase, in part because patients will demand it. “Patients are empowered,” she says. “They know about apps and other technologies available to them to make participating in clinical trials easier.”
Rickenbacher admits that federal regulations are still behind the curve, though she notes that’s usually the case where new technologies are concerned. Pointing out that the U.S. Food and Drug Administration and other regulatory bodies have generally been favorable—and even encouraging—of remote trial operations during the pandemic, she believes regulators will ultimately support their implementation.
“We don’t have a crystal ball that can tell us exactly what’s coming on the regulatory front,” she notes, “but we’ve seen what regulators have done in the past, and we know what their goals are.” Regulators will want to help boost adoption of safe remote monitoring, drug dosing, and other activities once relegated only to brick and mortar study sites.
Acknowledging that not all trials will work in a DCT or even hybrid format, and that brick and mortar sites remain vital to the clinical trial ecosystem, Rickenbacher believes the ability to safely deliver trial medications to patients remotely will go a long way toward improving patient recruitment and retention. Leveraged properly, innovative technologies can get trial drugs to patients “and reduce errors in dosing” in the process, she adds.
Looking ahead, she believes there’s a place for a range of trial designs, “but the vast majority are going to be in the middle,” with a hybrid approach featuring onsite and offsite components.
Author: Michael Causey