The other week, CluePoints in conjunction with HighPoint Solutions delivered 3 European Roadshows in Basel, Copenhagen and Cambridge, focusing on practical, case-based methods for addressing the challenges of Risk-based Monitoring (RBM). As well as hearing from key opinion leaders in the industry, each event was an ideal forum for attendees to share thoughts and experiences. The events were attended by over 90 Bio-Pharmaceutical Sponsors and Contract Research Organisations that provided a diverse and stimulating dynamic, especially given the ICH E6 (R2) content that targets CRO oversight by sponsors.
A number of themes were recurring across the events and made for lively discussion. The first was a simple but important concept in that the audiences didn’t feel that all industry stakeholders properly understood why they were needing to implement Risk-Based Monitoring within their own businesses. There was a feeling that beliefs existed within the industry, that this was a ‘mandated’ activity driven by a change in regulatory thinking rather than a desire to maximise the quality of clinical data. A quick poll of the audience showed that in some organisations, the RBM activities were attached firmly to the concept of quality, while in others it was regulatory change and, in some cases, even being driven by the need to try to lower costs. It’s also worth noting that in terms of attendees, about a quarter had active RBM initiatives within their own businesses. There was then a discussion on assessing organisational readiness to implement RBM and where it was important to focus.
One of the dangers that was discussed following from the above was without proper understanding of the reasons for RBM, coupled with looseness of implementation, could lead to reverting to old practices when issues were detected on a clinical trial. A number of attendees had seen a reversion to 100% SDV as a monitoring activity despite trials being initiated with a risk-based approach to quality management and monitoring. There was also feedback that trials had been initiated with the implementation of a RACT to begin with, but then operational practices had remained consistent with previous trials and ways of working.
A major discussion area was the evolution of roles and responsibilities to support RBM trials, especially the evolution of the ‘Data Scientist’ role that supplements the data surveillance activities of monitors and data managers. The discussion continued that this role typically evolves from staff who have historically been data managers, although there is still diversity within the industry. There was also comment that some organisations had restructured data management and monitoring into a single entity, reiterating the importance of these roles to the implementation of risk-based quality management in general.
Some attendees described their challenges in the development and application of Quality Tolerance Limits (QLTs). These pre-defined limits are intended to help identify systemic problems that may influence trial results or patient safety. The few sponsors who have started the effort are encountering challenges in defining, tracking, and keeping these limits up to date. CluePoints and HighPoint Solutions are rolling out software features and processes to address this evolving area of the risk-based approach.
The application of artificial intelligence and machine learning within the clinical trials process to guide disparate stakeholders through the planning and execution of clinical trials through targeted risk management is both a current capability and evolving trend for CluePoints. This helps support the industry as it moves to implement risk-based everything (RBX), a holistic risk-based approach to quality management within its operations.
All 3 events were excellent opportunities to learn and share experiences that elicited frank and open debate from all. Given the success of these last week, CluePoints is looking forward to facilitating further events in the future. If you’d be interested in attending one of our future events, please feel free to send an email to [email protected] to register your interest and help us identify suitable locations for future events.