Earlier this month, the U.S. Food and Drug Administration (FDA) debarred a study coordinator for a drug clinical trial at an institution in the agency’s Northern District of Illinois, alleging the use of fictional patients and skewed reports, among other serious charges. While it represents an “extreme and rare example,” the FDA’s action should serve as a reminder and wake-up call for sites and other personnel, says Bev H. Lorell, MD, a consultant with law firm King & Spaulding.
Sponsors need to spend enough time on due diligence to ensure that a principal investigator (PI) has the time and resources to work closely and in an ongoing basis with study coordinators, Lorell says. Sponsors should also make it clear that they intend to follow through with PIs, and will expect them to remain personally involved in the trial from start to finish, she adds.
Sponsors must actively engage their senior leadership to work with PIs and discuss expectations in terms of patient engagement and other hands-on aspects of the trial, Lorell says. Sponsors need to have a system in place where they can spot red flag outliers early—such as trial enrollment occurring much more quickly than expected, or a lack of reported adverse events in a high-risk situation—and swoop in to make sure the trial is following protocol. Risk-based monitoring (RBM), executed properly, can help sponsors and PIs recognize and address potential trouble areas early in the cycle, Lorell says.
“Too often these sponsor interactions occur only with the study coordinator, when it is the PI who has the ultimate oversight,” Lorell says. The FDA knows PIs are overextending themselves, she adds, noting that, “It recognizes that [overextension] is a problem, and that’s why one of its major initiatives” is to promote increased use of RBM. Time and money costs can be significant when setting up an RBM system, she acknowledged, but the long-term benefits make it well worth the effort.