Impacted by new technologies, a pandemic, and a host of other factors, the clinical trial landscape has inarguably undergone a dramatic transformation in 2020.
“COVID-19 will permanently change everything about how we conduct and manage clinical trials,” says Michael Hamrell, PhD, RAC, FRAPS, CCRA, RQAP-GCP, FACRP, president of MORIAH Consultants, a Good Clinical Practice (GCP) consulting firm.
Noting there was already a powerful movement toward the adoption of risk-based monitoring, Hamrell believes the trend has been accelerated due to the pandemic and the requirement to shut down live visits and isolate. “Companies have learned that effective oversight and monitoring can occur using virtual technology without a loss of confidence in the data,” he says.
However, training might not be keeping up, worries Hamrell. “The focus over the last number of years has been on GCP training and making sure that the training is documented [with an emphasis on] and noting it’s completion, without a consideration of whether the training was relevant and meeting the need,” he says. “There is too much ‘box-checking’” and not enough focus on “whether it was relevant, useful, or practical.”
It’s also time to better synchronize training efforts, Hamrell says. “Research staff are often subjected to multiple training sessions on the elements of GCP from multiple sponsors, rather than [being able to] focus on how it applies to their study and practical implementation.”
Hamrell calls on industry to make training protocols more specific and relevant. “Spend less time on basic GCP, which everyone knows, and talk about how GCP applies to the specific study,” he suggests. “Focus on areas that are the usual problems in clinical trials, not just the standard ‘menu’ of talking points [and] highlight potential areas of concern for the study, not just general issues.”
An improved focus on training might also translate into less eventful U.S. Food and Drug Administration (FDA) inspections, Hamrell says. For many years, FDA has cited clinical trial practitioners for the same shortcomings over and over, notably, not following the protocol, over-delegation, and lack of documentation of principal investigator (PI) oversight.
The major inspection findings from the FDA often center on how the PI and site fail to demonstrate adequate oversight and compliance and poor understanding of the study and GCP, Hamrell says.
Further, it’s not just the clinical trial industry that has to adjust to a new normal, Hamrell says. Regulators are being asked to think and operate differently, too. “I think that just like sponsors and contract research organizations have had to change their approach to clinical trial oversight, the FDA (and other agencies) will also change their approach,” he notes.
Despite all the changes, Hamrell believes the use of remote access to files and data will remain an important part of future inspections. “This will allow FDA to complete some of a review before it gets to the site,” he notes. It can shorten the time needed onsite to complete an inspection, but it
will not eliminate onsite inspections, he says. Instead, he expects, it will “change the focus and time effort involved.”
Author: Michael Causey