Are The Regulatory Authorities Ready For The Adoption Of Risk-Based Monitoring?

Firstly, thanks to those of you who got involved with our recent discussion about current best practice in Risk-Based Monitoring, it was great to hear from you. Next, we asked our partners to tell us about how they think the regulatory authorities will respond to the adoption of Risk-Based Monitoring, and importantly, if they are ready for it.

With both the FDA and the EMA releasing draft guidance for the conduct of Risk-Based Monitoring, there is no doubt that a shift to this approach by sponsors and CROs will be welcomed by the authorities. However, when it comes to actually putting it into practice, our partners still have questions about whether those carrying out audits and inspections are in practice ready and willing to accept these new methodologies. James Streeter, Senior Director of Life Sciences Product Strategy at Oracle Health Sciences commented that despite the regulatory authorities pushing for widespread adoption of Risk-Based Monitoring, “in reality, it may take some time for individual auditors to accept the new Risk-Based Monitoring methodologies and how these differ between organizations,” and this could prove to be a potential hurdle for the industry.

In an industry typically slow to adapt to change, it is no surprise that some organizations are yet to respond to this guidance – perhaps because it is just that, guidance. Karen Fanouillere, Biostatistics Project Leader at Sanofi, gave reasoning for this, saying that, “while the authorities are definitely on board with Risk-Based Monitoring and already advising the industry to adopt this approach, they have yet to outline any specific recommendations or guidance on exactly how they would like to see it implemented.” Our partners were in general agreement that the introduction of the ICH (E6) Addendum later this year should provide some of the much-needed clarity and ‘specifics’ that the industry is waiting for, and will also force the hand of many organizations still resisting the change.

All that said, the majority of our partners are in regular discussions with the authorities and many are of the opinion that Risk-Based Monitoring methodologies which, as Dr. Peter Schiemann, Managing Partner, and Co-Founder, of Widler & Schiemann, said, “are based on data and facts, and follow a clear plan,” are likely to be accepted by the regulators. Steve Young, Senior Director of Transformation Services at OmniComm agreed with this view point, saying: “The door has been opened very clearly by the regulatory authorities to encourage the industry to move forward with Risk-Based Monitoring,” and, “as long as sponsors have a well-documented quality management plan that demonstrates how risk assessment was carried out, how the monitoring plan was guided by that risk assessment and makes clear the findings (and any remediations), then there should be few issues.”

From the CluePoints perspective, we can certainly see that the agencies, via the various guidance documents, are clearly insisting that sponsors and their partners adopt new centralized monitoring processes that will both improve data quality and reduce cost. The agencies themselves are also scrutinizing their own processes, and I wouldn’t mind betting that they will be adopting similar new techniques for selecting sites for inspection in the near future. The regulatory bodies have certainly given the industry the push that has been needed to affect change that will herald a new way of managing study conduct and ensuring data quality while reducing risk. At CluePoints, we use a very effective analogy to the airline industry in the late 1980s whereby that industry went through a comprehensive process re-engineering designed to reduce costs but also improve safety. The results were extraordinary, and the similarities to the challenges we now collectively face in Pharma are remarkable. Let us know if you’d like to hear more.

What are your experiences of this? Do you have any advice to share from your experiences with the regulators?

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