Protecting patients was at the forefront of presentations and other discussions during ACRP’s 2021 virtual conference yesterday (September 30), with speakers and attendees swapping case studies and best practices to elevate clinical trial conduct.
“Always, always, always try to focus on safety,” said Elizabeth Nelson, president at Regulatory Risk Management. Calling it a “shared responsibility,” Nelson noted it was critical for clinical trial practitioners to do a proactive job when it comes to assessing risk throughout a trial. “Risk profiles can change,” she said. “It’s an ongoing process [because many] things can change during a study.”
For example, Nelson asked, “are we giving all the information principal investigators need to protect patients during the consent process?” Conducting trials during the COVID-19 pandemic has put new stresses on both people and systems, she added.
Privacy issues have changed since the pandemic began, and trials must be open to mid-course adjustments as new issues arise, Nelson said. Another concern is whether institutional review boards (IRBs) are being provided with enough information to protect patients and ensure an efficient, effective, and compliant trial, she noted.
Nelson also called on some IRBs to step up their activities. “If an IRB asks a question, and the site doesn’t respond, the IRB should push back” to get the required information, she said.
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The IRB issue is becoming more serious, noted consultant and ACRP Fellow Janet Holwell. While the list of the most common clinical investigator inspections observations has remained relatively static over the past several years, Howell noted a new entrant has crept into the top list: “Failure to comply with IRB requirements.”
“Draw a line in the sand” regarding how much risk is acceptable in each situation during a trial, said Mindy Ditch, president and founder of Bloom Clinical Research.
Turning to the issue of protocol deviations, Ditch said it was vital for clinical trial practitioners to address those with a strong corrective and preventive action (CAPA) program. Handling protocol deviations properly is the foundation for “protecting patient safety, data integrity, and regulatory compliance,” she added.
“Identify risks to subject safety, data integrity, and regulatory submissions, and proactively plan how to mitigate these risks,” Ditch said. “Perform root cause analysis to properly address compliance issues and analyze protocol deviation trends within a study or research site.” The emphasis should be on ascertaining the “impact of errors on human subject protection and reliability of trial results,” she added.
The ACRP conference concluded with a session featuring Holwell and Glenda Guest, ACRP Fellow and president of NCRA, on how to handle a U.S Food and Drug Administration (FDA) inspection and manage the consequences.
Acknowledging FDA inspections can be “stressful and grueling,” Guest noted “your work is just beginning at the end of the inspection.” In fact, the time just after an inspection often presents regulated entities with their best opportunity to remedy the situation and mitigate the fallout, she said.
It begins at the end of the inspection, Guest said. “You should request a copy of your Establishment Inspection Report (EIR) during the exit interview,” she said. While the EIR is not necessarily complete on that day, and it can take many months for it to be finalized, seeing the first draft may be helpful because “the FDA investigator may have noted areas of concern which will be the subject of the next inspection, so obtaining a copy is good preparation for a future inspection,” Guest said.
Further, while it’s not mandatory to respond to a Form FDA 483 (Inspection Observations), it behooves you to do so, Guest said. “It communicates your commitment to addressing FDA’s concerns and demonstrates you are taking actions,” she explained.
Better still, if the observations are relatively minor, and solid response might prevent the FDA from issuing a Warning Letter. Worth noting, Guest said, is that 483s are generally not publicly released, while Warning Letters are made available to everyone.
Holwell outlined the most effective ways to respond to an FDA inspection response, including keeping timeframes tight for when an issue will be addressed, making realistic commitments, and providing ample detail about what corrective actions are or will be put in place.
Author: Michael Causey