The evolution of RBM – reflections on CBI’s RBM event, November 2018
It’s always interesting going to a conference which runs each year on a specific industry topic – in this case RBM. It enables you to see the progression of the industry at a macro level, usually just enough to see some progression – we’re not known for our agility in life sciences!
Having attended this conference fairly consistently since 2014 when RBM was really starting to hit the headlines, I thought it would be interesting to share some of the observations I made from both speaking and listening at the event.
Now that central monitoring and RBM have become business-as-usual for many businesses, and those businesses are seeing the value first hand, a strong community of evangelists is forming and those people seem determined to communicate their successes, their approach, their challenges and their future plans. This is helping create a bow wave of pressure and support for the next wave of adopters. The speakers and attendees at the event were all genuinely interested in helping each other progress. It is always frustrating at these events that the community tends to dissipate after the event as everyone goes back to their day jobs. At TRI are putting quite a bit of thought into how we can help maintain that community and continue the momentum after the events – watch this space.
Back in 2013/14 when RBM was first making the headlines, there was a rather cynical, but popular view that the core value in RBM was saving money on on-site monitoring costs. This was then followed by the realisation that doing less on site monitoring needs to be backed up with more central monitoring, more thought, more planning and more ongoing quality management, and suddenly is wasn’t as appealing was first thought. I got the feeling that there was a bit of a period of depression with RBM around 2015/16 as companies realised that gross margins on trials weren’t about to increase 25% overnight. What is evident now though is that those companies that could see beyond the primary goal of cost savings, and were more focused on safety, quality and compliance (with ICH E6 R2 helping build momentum again) are now actually saving money! Why? Because they have thought about the journey to quality – the processes, the data, the systems and the people – they have got their houses in order and they are making day-to-day decisions based on what they see in the data, and not following a routine plan of monitoring visits and SDV. As in life, it is often the journey to achieving something that is the reward, and that is becoming more and more evident. With large pharma companies citing 18-20% genuine cost savings as a result of RBM, the business case looks stronger than ever – what’s changed is the realisation that it takes a bit of work to get there.
Source data verification (SDV) has long been one of the focal points of discussion in the RBM debate. With an abundance of empirical evidence that shows SDV has little or no impact (generally accepted to be less than 1%) on data quality, the popular view of 2014/15 was that RBM would be a good way to reduce SDV levels – maybe picking specific sites or subjects and focusing efforts there. The view at this year’s event was very much – ‘why would you use RBM to do less of something that adds no value in the first place?’ Hard to argue that logic really. It really does seem that SDV has less and less of a home in the new trial management paradigm. The new questions we need to be asking of ourselves and of our data are more along the following lines:
- ‘How does the subject’s journey map to that described in the protocol?’
- ‘Is the protocol being followed correctly for each subject and where is the evidence?’
- ‘Does the data look like we expected it to look, and if not, why not?’
- ‘If the data doesn’t look like we expected it to, which subjects do we think might be affected?’
There are far more probing questions, and they are going to lead to much more insightful management of quality and safety.
Sponsor / CRO relationship:
There was a lot of debate about the relationship between sponsors and CROs under the umbrella of RBM. Again, the discussion has progressed since the early days when the main school of thought was that RBM was the job of the CRO, and guess what – we don’t have to pay as much for monitoring as we used to! Fortunately this conversation has matured significantly. One of the things that E6 R2 has made very clear is that Sponsors remain accountable for outsourced services and that evidence of vendor oversight during trial conduct is paramount. So Sponsors and CROs are clearly bound together under R2, both with skin in the game when it comes to quality and safety management. When talking to sponsors at the event, many of whom were in multiple CRO partnerships, their views were very common – at the sales cycle the CROs all have a good story to tell – their PowerPoint skills are incredible…..It’s at the point of delivery that things start to wobble. With any partnership, expectations need to be set clearly from the outset. For many companies, both on the sponsor and CRO side, who are just starting to execute to the RBM model, it is not surprising that with no real framework to work to the likelihood of meeting mutual expectation is highly unlikely. The Sponsors don’t really know the right questions to ask in the first place, and so the CROs keep the conversation light. One of the consulting tools we have built at TRI is a framework for managing such expectations, and those sponsor / CRO partnerships who have used it have enjoyed a much better outcome than people feeding back at the conference. We’d be happy to talk it through with any interested parties.
Four years ago, the conversation about RBM was ‘what is it and why should we do it?’ Today it is very much ‘how do we do it well and how do we grow from here?’ That simple shift is what makes me the most excited. There is no silver bullet for RBM, there is no one algorithm, no one study design, no one process. It takes a team to think, to work together, to utilize tools to get the most from the data we have been sitting on for years and draw intelligent conclusions from that data. The benefits of getting it right are huge, for industry, for patients and for us as part of the community of people who genuinely care about progress. This is a turning point in our industry and we at TRI couldn’t be more excited about being in the thick of it. Thank you all to everyone who contributed and the dozens of fascinating conversations we had at the event.