In Greek classical literature, “know thyself” is inscribed over the entrance to the temple of Delphi. Poor Oedipus doesn’t know himself at all, and that’s where his troubles begin.
For Nicole Tierney, CCRA, BA, a principal clinical research associate with NAMSA, a medical device contract research organization (CRO), it’s also important to “know what sites are capable of” when it comes to remote monitoring strategies. The COVID-19 pandemic has ushered in a new era of remote risk-based monitoring (RBM) in the clinical trial landscape, but the conditions were obviously far from ideal and left many sites, especially smaller ones, scrambling to keep up, she says.
“In some cases, we have to help smaller sites revise their standard operating procedures (SOPs) and come up with what works for them” to leverage RBM remotely, she says. Her shop works mostly with device trials across the U.S., China, Australia, and Europe.
“It’s been a difficult” transition to remote for many sites, Tierney says. “The willingness to use remote monitoring didn’t come overnight,” she adds.
It’s further complicated in Europe, and especially in Germany, where there are much tighter restrictions on what kind of remote monitoring and information sharing is permissible under the regulations, Tierney says. When COVID-19 began to significantly impact the clinical trial landscape earlier in 2020, many sites had not yet made much effort to adapt to remote monitoring, she adds.
“We would ask in site qualification questionnaires, for example, if the site allowed remote access to emergency medical records,” but smaller sites often hadn’t done much research in the area or done much to enable it, Tierney says. However, “a lot of sites in the U.S. are [now] opening up to remote monitoring strategies, but it takes time to change processes,” she notes.
For both sites and sponsors/CROs, “flexibility is key,” Tierney notes. “CROs have to be as flexible as sites and come up with solutions that work for what the regulations, SOPs, and information technology departments” require, she says.
Tierney and Sue Sullivan, RN, CCRA, manager of clinical research services at NAMSA, will present a session on remote monitoring strategies during the May track of the ACRP 2021 virtual conference.
Author: Michael Causey