Presentation by Jean Mulinde, MD, FDA Senior Advisor, Division of Clinical Compliance Evaluation. to the MCC Summit 10th September 2020
In Jean’s informative presentation to the Summit attendees, I was struck by four interconnected topics.
The first was on industry’s “Progress on the Quality Journey”. In Jean’s view, over the last eight years, many firms have made significant progress, but some are still only just starting! Many have implemented overarching Quality Management Systems that include mature risk assessment and management processes, quality by design principles at a study level and in some cases fully developed risk management processes. The area most behind and in need of further development is the need for overarching data governance procedures and processes.
This quality journey is important because, in Jean’s view, the companies that were furthest along that journey were the ones best placed to cope with the pandemic. They were the ones most capable of transitioning after regional pauses to continue clinical trials. Jean commented that firms with a culture of quality, and that have good risk assessment and management processes already embedded in their thinking and way of doing things, were probably better prepared to deal with the new risks brought on by the public health crisis.
That led to a significant point about inspections and the positive impact RBQM can have on clinical trials. Jean used a great case study to exemplify the point. The case study showed a large, randomised, blinded, placebo controlled cardiovascular outcome study with 600 global sites and 10,000 subjects. Centralised monitoring had flagged a site because it had approximately 5% of the total study population and there was a concern over SAE reporting. Through a combination of site inspection, documentation review and an implemented action plan, the data from the site was considered adequate to support a regulatory decision and was therefore included in the final submission. For Jean, the key RBQM lessons included the importance of the quality approach, centralised analytic procedures, the early identification of issues and intervention, the identification of critical data and having documented processes.
Jean’s request at the end of that case study was for organisations to ‘shift’ their thinking from a negative “What if we implement things like risk based monitoring FDA investigators find something on an inspection that we didn't monitor or identify?” to a more proactive “What if we don’t shift the way we do things by implementing Quality by Design and risk based monitoring, and then FDA raises a data integrity issue that our study oversight and monitoring methods did not identify?”.
Jean left us with a quote from William A Foster.
“Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skilful execution; it represents the wise choice of many alternatives”
Thank you Jean, a really helpful and interesting presentation.