In recent conversations with some people in the industry, I was struck by their tone and approach to RBQM and sites. It felt as if they wanted to use RBQM, and Central Monitoring in particular, as a tool to ‘beat’ sites with when there’s a deviation from planned KPIs, KRIs and QTLs.
The strong advice to all our customers is that it’s better to engage and communicate with sites whenever and wherever possible. ICH E8 (R1) encourages the collaboration and communication with stakeholders, including sites. And it’s best to start early, at the Protocol Assessment stage. That way sites can better understand the study priorities, objectives, and potential risks. If they understand those, they can better react if metrics start to go off track.
Anecdotal evidence shows that sites are under huge pressure post pandemic. It obviously changed many site priorities and caused massive disruption to ongoing clinical trials. And with the re-starting of paused trials, as well as the starting of new ones, sites are facing new and different pressures, including patient recruitment, the recruitment and retention of staff, and the pressure of competing studies from different CROs and Sponsors.
For all those reasons and more, it’s obvious that better communication and engagement with sites is the way forward. But it is a two-way street. Just telling them about your study priorities is unlikely to get the result you want. Understanding their challenges will enable you to make better decisions. And that takes time and effort.
For example, CRF Data Entry Time is often used as an indicator of quality, the longer the time, the greater the risk or concern. But if you know a particular site has a member of staff off sick, or has left and they’re struggling to find a replacement, you can make a better decision than calling the site and starting a conversation with “Why are you failing?”
It’s not just RBQM, it’s common sense.