1 – There are still a significant proportion of trial sites who are not being informed that there is a risk-based approach being taken to the monitoring of their site. This is an easy issue to remedy and one that will start to build trust immediately.
2 – There is concern from sites that RBM is being used to measure their performance and potentially influence site selection for future trials. To this point it is key that the Sponsors or CROs running the sites take time to explain why they are using RBM and what the benefits to the sponsor, subjects and sites are. To that last point, I do believe that there are benefits to sites with RBM. For example, if a nuance of the protocol has not been fully understood by the site and that results in a data set which shows some statistical variance outside the norms for the study as a whole, this would be highly likely to be picked up early by a well structure RBM approach, but quite possibly not picked up by SDV. This will allow intervention and course correction with the site and allow the trial to continue with a higher quality output. All trial sites want to do a good job for patient safety, clinical research and commercial reasons, so why wouldn’t this sort of quality oversight not be seen as a benefit?
3 – Sites are concerned that RBM directly equates to a significant reduction in monitoring time on site. This concern has possibly been exacerbated by early excitement regarding RBM that monitoring costs would immediately by cut by 40% and so on. The reality is that RBM allows a more focused used of monitoring time and gives monitors more direction in how to use their time on site as effectively as possible. This may mean that there is more remote contact with the site, but there are still components of the role of a monitor which have to be performed on site, and so that contact with the site is never going to go away. The reality is that the nature of site contact wil evolve with RBM, but we hope in the long term, for the better.
Being mindful of these three factors as a starting point may just start to help build back a little of the trust and collaboration which has been challenged by the RBM movement in the last couple of years.