The first presenter is Mathieu Ouwerkerk, Janssen Pharmaceuticals.
Mathieu starts his presentation with an overview of the different kinds of audits that were performed during the COVID-19 pandemic from which it’s clear that the audits in the audit program were largely changed from onsite to remote, ensuring they were conducted in line with the latest regulatory requirements. Also, the audits in the audit program were reprioritized with a larger focus on COVID-19 studies but still taking into account overall quality assurance for the clinical study program and using a risk-based approach.
The audits being conducted were furthermore limited by lack of travel options, lack of time in the study teams and lack of time/resources at the audited locations.
The site audits were conducted more remotely by conducting a desk top documentation review, including medical records. Some site audits were conducted in a hybrid fashion with a remote or desk top documentation review, interviews and facility tour and an on-site co-auditor using new auditing methods such as tablets and smart glasses. Reviewing medical records remotely or using new technologies is severely hampered by the current guidelines such as the GDPR.
An interesting “problem” has been encountered during this pandemic and the changed way of auditing it has induced and that is the fact that some institutions where clinical studies are being conducted have refused to allow monitors and/or auditors on site at all. They have also let it be known that they will continue to refuse entry to monitors and auditors when we are “back to normal” which means that companies need to find a new way to still fulfill their obligations regarding quality assurance.
The new guidances issued by the regulatory agencies didn’t seem to apply to inspections as the inspections were still ongoing, both on-site and remotely or also as a hybrid mix of both.
The inspection focus didn’t seem to be hampered by the new guidances either, although they tended to look a bit more closely at risk mitigation.
A risk assessment has been performed to identify whether the changed way of conducting audits is successful and no important data was missed.
The second presenter is Jonathan Read, Gilead Sciences.
Jonathan starts his presentation by mentioning that focus changed from infectious disease studies in March 2020 to phase 3 COVID-19 studies rapidly as resources were swiftly allocated to those studies using already existing risk management tools and using new auditing techniques as no on-site visits were possible. Challenges were (as also described by Mathieu): no on-site sponsor or CRA presence, speedy site activation, high enrollment numbers and short study timelines paired with large numbers of requests for an unapproved product to be used for compassionate use in an ICU setting in patients that were often too unwell to give their (re)consent for the study.
Basically Gilead took the same approach as Johnson: changing on-site audits into remote audits, in line with the current guidances and encountering the same difficulties with regard to local rules and pushback from the sites because of limited resources.
To manage the changed circumstances as well as could be, a cross functional COVID-19 Working Group was established which interpreted regulatory guidance documents and provided guidance to the study teams about the conduct of the clinical studies during the pandemic and developed new tools to be used such as study specific crisis management plans.
In parallel an internal audit looking at COVID-19 risk management was conducted in which the TMF was reviewed as well as the monitoring plan, trackers/tools used to mitigate risks at site level and protocol deviation trackers. A pragmatic approach was used and good documentation was seen which enabled the reviewers to reconstruct events. The overall outcome was that study teams were doing a good job.
A vendor audit was also conducted which was part of the routine audit program, however, as an example one of the COVID-19 trials was chosen. Focus was on sponsor oversight, monitoring etc. The audit was conducted remotely using modern technology, which worked well.
Two US FDA inspections were remotely conducted. The inspection focused on the usual inspection items such as clinical data management and management of site start-up. Challenges were the short notice of the upcoming inspection, the number of document requests and the different locations in different time zones being involved.
One inspection was conducted in Germany, which was an on-site inspection with the standard inspection focus but with emphasis on the remote monitoring process.
Lessons learned from the inspections conducted during the pandemic are basically that it’s very helpful to install an inspection readiness lead early on and to incorporate inspection readiness into all study related activities both at the sponsor and at the sites, including QC processes. As always good documentation is vital, as is having sufficient resources.
In order to be successful in auditing and inspecting of clinical studies during the pandemic all those involved should be pragmatic, flexible and understanding of the other party’s difficulties. Remote auditing needs well-organized planning and the preparation and audit conduct is more time consuming.
Dit webinar was bezocht door ongeveer 15 deelnemers.
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