I recently ran a webinar on “6 Gap Analysis Steps to Kickstart Your RBQM Implementation”. In part it was inspired by the Association of Clinical Research Organizations (ACRO) report “Risk-Based Monitoring in Clinical Trials: Past, Present and Future” that highlighted the slow take-up of RBQM in pre-pandemic clinical trials.
Before the webinar I decided to test some of the key points raised by the ACRO report. Specifically I wanted to test whether there had been an increase in the number of organizations conducting Risk Assessments (33% in 2019) and Central Monitoring (19%) on their clinical trials post pandemic.
Over 80 people from 60 organisations registered for the webinar and all but 5 were kind enough to answer a series of questions, including whether they were conducting Risk Assessments and Central Monitoring. Now I recognize that my survey was no where near as big as the ACRO one (they had over 6,500 clinical trials), nor was my methodology as rigorous or robust as ACROs, so please don’t write in and complain. The organizations in my survey covered everything from a “tiny bio-tech” (their words, not mine) right the way through to some of the biggest and best known Sponsors and CROs in the sector. And of course, I just took what people said at face value. But as a “rough indicator”* I thought the results were very interesting.
Over 90% said they were doing Risk Assessments and over 60% said they had implemented Central Monitoring. That implies there’s been a big increase in both since the pandemic, which is what we would all have expected, right? The one result I didn’t expect was the answer to the question “Do your organization have a named person responsible for RBQM?” Over 50% of organizations said no. I was very surprised for two reasons. The first (and most obvious) is that RBQM is a requirement. The regulatory authorities are doubling down on RBQM with ICH E6(R3) and E8(R1). It’s not going away. If it’s so important, then why aren’t organizations naming someone specifically responsible for it? Which leads on to the second reason I was surprised. My Project Management training and experience tells me that if someone isn’t named as responsible for the delivery of something, the chances are it won’t happen. That’s because human nature is programmed to think “that’s someone else’s job” and it doesn’t get done.
So if you only do one thing when it comes to successfully implementing RBQM, make it someone’s responsibility. Put RBQM in their job title. Set out what they need to do in their job description (e.g. implement Risk Assessments on every clinical trial; train all staff in the benefits of a Risk-Based Approach; implement Central Monitoring for all clinical trials). And if you really want to ensure it’s done and done well…link RBQM deliverables to performance related pay. Just a suggestion 😊
Note: * - A new statistical term I’ve made up…I think it will catch on