Did changes in your trial monitoring result in critical data gaps that can impact FDA approval?
During the COVID-19 pandemic, restrictions put in place to limit the spread of the virus made most traditional clinical trial monitoring methods logistically impossible. While thousands of trials stopped altogether, trials that continued throughout the acute phase of the pandemic did so by adjusting the method and frequency of clinical monitoring efforts. Due to the need to isolate impacted individuals and the enormous strain on the healthcare industry, there was an unprecedented shift toward remote monitoring and many novel data collection technologies and approaches were employed.
As a response to the upheaval that ongoing clinical trials were experiencing, FDA relaxed the expectations for clinical trial monitoring during the most restrictive period of the pandemic. This “Gap Period” between normally enforced monitoring activities pre- and post-pandemic saw trials shift fully to remote monitoring, decrease the scheduled frequency of monitoring visits, and sometimes even pause monitoring activities altogether. Trial data continued to be generated, but the monitoring efforts to ensure the quality and integrity of that data looked vastly different than they had before pandemic restrictions were put in place.
The Challenge for Sponsors
Despite the FDA relaxing monitoring expectations, the monitoring requirements and regulations remained the same, and once pandemic-era restrictions were lifted, sponsors largely resumed operations according to pre-pandemic standards. Upon this return to customary clinical monitoring practices, sponsors may not have necessarily addressed the integrity of their Gap Period data or any issues pertaining to participant protection that may have occurred.
Sponsors should be prepared if FDA asks during pre-approval inspections to demonstrate that any critical issues of data integrity and subject protection were not missed during the pandemic.
For trials conducted during the pandemic that are still ongoing, non-conformances during the Gap Period may not have been documented and addressed — or even discovered yet. Sponsors should be prepared if FDA asks during pre-approval inspections to demonstrate that they have ensured that any critical issues of data integrity and subject protection were not missed during the pandemic. Without having a robust response to that inquiry, sponsors are at a risk of more inspection findings during regulatory audits.
As a sponsor, how do you fill that gap?
A Targeted Approach to Ensuring Trial Integrity
With this risk to development timelines and budget, sponsors need a solution that can ensure confidence in the quality of their pandemic-era trial. Auditing each site is a cumbersome solution; it may be prohibitively costly and is not fit-for-purpose. A more effective approach to ensure audit-readiness is to perform clinical monitoring oversight visits tailored to the Gap Period.
Beaufort has a proven and flexible process that can objectively identify red flags and blind spots that can emerge during regulatory audits. We perform oversight visits to specifically address the period of time during which a trial was monitored according to more relaxed standards and provide reporting that supports trial results and reduces regulatory risks. Ensuring the integrity of Gap Period trial activities, and the quality of trial data generated during that time, allows all levels of an organization to have confidence in the validity of their trial results and their readiness to defend their trial during regulatory audits.
Contact Beaufort today for a consultation on how we can customize a solution that best suits your needs.