I spoke with François Torche, CEO of CluePoints, to learn about challenges and questions that arise when implementing Risk-Based Monitoring.
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If you want to have a comprehensive RBM solution and implementation, you should also include patient data.
September 6, 2016 | by Andrew Juurinen, M.Sc.
Organizations are implementing a Risk-Based Monitoring (RBM) approach to clinical studies more frequently than ever before. This week, I spoke with François Torche, CEO of CluePoints, to get his thoughts about some of the challenges and questions that arise when implementing an RBM process.
To get more insights about RBM, I encourage you to join, François Torche and Lynne Cesario, RBM Program Lead from Pfizer, for their upcoming webinar, “Removing the ‘Risk’ in Risk-Based Monitoring: What We Have Learnt in the Last 4 Years from the Practical Implementation of RBM”.
When implementing RBM, are there different challenges faced when involving a smaller versus a larger sponsor?
The answer is yes, smaller and larger organizations have different challenges. The biggest challenge for large organizations are the changes that have to be made to the organization’s structure and to their processes. For a large organization, it may be more challenging to implement than for a small organization that is more agile. The biggest challenge in RBM implementation is about people and processes – explaining why RBM is a good thing, training people, then changing processes.
In your opinion, does using a broader approach to RBM, by including operational and clinical data, as well as, patient data (e.g. laboratory data) add value to the RBM process?
This is what makes our solution unique, so I'm very much in favor of analyzing all data. As you will see during my presentation, you’ll need to look at these types of data at different points in time during the process, and with a different level of scrutiny. You look more regularly at operational data and will be looking less frequently at lab data, ECG data, and so on. So yes, if you want to have a comprehensive RBM solution and implementation, you should also include the patient data.
At what point should an organization start to consider implementing RBM? Can it be done mid-study if an organization hasn't yet on-boarded an RBM process? If so, should an organization be tracking information in a different manner?
I think that if you want to implement RBM, you have to start from scratch. Implementing RBM in the middle of study is challenging, so ideally, you would like to implement RBM before you start a study. There are a number of activities related to RBM that happen before you start the study. RBM is not just about reducing site monitoring visits, but it's also about quality by design, making risk assessments, identifying risk before you actually start a study, adapting your protocol, and making your protocol more simple.
That being said, our approach at CluePoints is different from just RBM. There is nothing preventing you at any point in the study to perform data quality assessments – but then, we may no longer call that, RBM.
For those studies that have already started and are in the middle of their process, you wouldn’t implement KRIs, for example. However, you will still be looking at all the data, every three or four months, to perform data quality assessments to ensure that you have quality data – that you don't have any inconsistencies between your different sites, and different patients.
RBM in the middle of the study is still possible but it's very challenging, and there are not many companies that are doing it, currently. Data quality assessments in the middle study on the other hand, absolutely.
As the industry is adopting more RBM studies, do you think the training of monitors is changing to look at things differently?
Yes, definitely. The work of the monitor is going to change. Instead of looking at everything, they’ll be spending more time focusing on what has been detected by systems, for a more targeted approach. The work is going to be very different, but we're really talking about the monitoring activities. What used to be called SDV, (source document verification), is going to be shifting to SDR, or source data review. You will be reviewing data, looking at what makes sense, what needs to be reviewed, analyzed and investigated. The rest of the role of the monitor, however, will not be impacted. There is still a need for compliance checking, training sites, and so on. That will not change. The biggest changes will be related to SDV and SDR.
How is RBM operationalized from a sponsor oversight perspective and what challenges are typically faced when trying to obtain a buy-in for using RBM?
I think Lynne Cesario will tell you better than I about how they plan to implement RBM. But, I would say that's a two-fold question. There are new functions and new roles for these organizations to consider that will be responsible for pre-digesting information, reviewing KRI dashboards, and performing data quality assessments. You have central teams investigating the data and conveying information back to the study teams, and to monitors in the field, to tell them what they should be looking at. There is a new role in these organizations, a central position, that we will call a data analyst or data scientist. I think at Pfizer they call it central data monitor.
For the second part of the question, we're back to the challenges, we're back to the fact that in those positions, in most organizations, those positions don't yet exist. When CluePoints came two or three years ago to some sponsors, their position was that they didn’t have the people to manage the processes. Now, we see, more and more, that these organizations do have those central data monitors to actually do the work. So again, it’s about processes, people, new roles, and new functions for these organizations.
What can the audience expect to learn from your upcoming webinar?
They will learn why it is important to look at everything, not just indicators and understand why it makes sense to look at operational data. They will also understand why, if you want to have a comprehensive RBM strategy, you also need to look at the other data. That would be my portion of the presentation.
Lynne Cesario will be sharing her experience about implementing RBM at Pfizer and explaining the central position that I just described - the challenges they face and their strategy for combining KRI review with data quality assessments, provided by CluePoints.
Don’t forget; you can ask François Torche and Lynne Cesario your own questions about RBM during the Q&A session of their upcoming webinar on Monday, September 12 by registering here.
Editor's note: Pfizer's speaker name for the webinar, Lynne Cesario, has been added after this article's initial publication.
Keywords: Risk-Based Monitoring, CluePoints, SDV
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