The Association of Clinical Research Organizations (ACRO) report Risk-Based Monitoring in Clinical Trials: Past, Present and Future released earlier this year is a really interesting and insightful piece of analysis. If you haven’t already read it, I highly recommend it.
The report details the take-up of eight Risk-Based Monitoring (RBM) and Risk-Based Quality Management (RBQM) components before and during the pandemic. What they found was (I think) disappointing from an industry perspective. But there is hope.
Before the pandemic, few trials implemented more than a few of the eight components. The rapid shift from on-site to remote and central monitoring demonstrated that transitioning to an RBM approach is possible without diminishing monitoring effectiveness, even in difficult circumstances. That has led to more interest and uptake of RBM and RBQM approaches across the sector. What is disappointing is that RBM, and more recently RBQM, has been talked about for years, but the adoption has been slow and difficult. The ACRO report presents a 2019 survey of 6,513 trials where only 33% had implemented initial and on-going risk assessments, even though risk assessment and management are fundamental to ICH E6(R2). Less than 20% of the 6,513 trials had implemented Central Monitoring.
While it could be argued that the data is now slightly out of date, the take-up results are in line with what we are currently finding when talking to potential customers. There is clearly a long way to go to get to “full RBQM”. And that begs the question, “What are the barriers to take-up?” The report cites several reasons, including challenges with execution within a complex trial, concern about regulator acceptance of data, and sponsor concerns relating to certain types of trial and site inspections. One of the barriers we’ve seen at TRI repeatedly in recent months is the lack of RBQM trained resources in both Sponsors and CROs. Those resources are increasingly sought after, and valuable as a result.
Despite the barriers to adoption, regulatory authorities encouraged increased use of RBQM during the pandemic. They are increasingly promoting RBM and RBQM with the revisions to E6(R3) and E8(R1). E8(R1) reached ICH Process Step 4 on 6th October and will now be processed for adoption by the regulatory authorities.
So RBM and RBQM aren’t going away. They are being accelerated. That means those implementation statistics will inevitably rise. At TRI we're trying to help accelerate adoption by providing free RBQM training. For example, our Risk Assessment webinar series has had over 2,000 people register so far this year. Next year we’d like to do even more.
We’re planning a series of free, ‘hands-on’ events where we’ll educate people on how to do risk assessments, implement risk controls, pick KRIs, KPIs and QTLs, use real study data to run Central Monitoring exercises, and practice good communication and reporting skills. We trialled this approach in the Nordics with one of our partners Klifo, and it was extremely well received by both Sponsors and CROs because it was practical, experiential training they just couldn’t get anywhere else.
We’re in the process of developing the content and agendas for the events to run in early 2022. If you’re interested in attending, or just finding out more, please contact me directly at firstname.lastname@example.org