Quality-Savvy Sites and Sponsors Better Positioned for Post-Pandemic Risks, FDA Official Says
Sites and sponsors that already have robust quality and risk-based management systems are better positioned to deal with new risks in a postpandemic world, one FDA official says.
Some firms are “just embarking on select pieces, while others have implemented overarching quality management systems that include mature risk assessment and management processes, [and] the use of quality-by-design principals at the study level,” Jean Mulinde, policy adviser for the FDA’s Center for Drug Evaluation and Research, told attendees at last week’s Clinical Trial Risk and Performance Management virtual summit hosted by Metrics Champion Consortium.
And while conceding that she didn’t have hard data to support the statement, Mulinde said “those firms that were the furthest along in their journey were the firms that were most capable of transitioning, certainly after rolling regional pauses, to continue clinical trials” in the wake of COVID-19.
Site monitoring during the pandemic is a major area of concern, she said. Stakeholders want to know “how to pivot to electronic informed consent or other types of consent procedures that rely on electronic systems.” Based on questions the FDA has received in recent months, it appears that many stakeholders have very limited experience with remote monitoring strategies. Some also are hampered by “relatively immature centralized monitoring capability, immature quality and risk management systems, the use of quality by design, and the absence of well-developed risk-based monitoring strategies in general,” she said.
The agency recommends that sponsors considering a switch from on-site to remote monitoring should first consider whether there is a compelling reason to do so. Appropriate procedures and technology for remote monitoring should be in place, Mulinde said, adding that sponsors need to check patients’ existing informed consents to see if remote review of records is permissible. She said an FDA review of a small sample of informed consents, conducted before the pandemic, found a “broad range of language” on the issue.
Mulinde said FDA also recommends that sponsors either establish a secure remote viewing portal between a site and a monitor or request that sites upload certified copies of source records to a sponsor-controlled electronic system. But she said the latter approach “may be more burdensome to sites.”