RBQM Ops 2022 - Key Considerations for Setting Up studies in Central Monitoring

Key Considerations for Setting Up studies in Central Monitoring

SUMMARY KEYWORDS
study, data, assessments, metrics, program, review, key risk indicators, data entry, team, implement, monitoring, serious adverse events, labs, query, site, safety, building, lastly, identify

DUNCAN HALL:

Our next topic is key considerations for setting up studies in central monitoring. And I'm delighted to announce Catalina Ortiz who's the associate director of risk-based study management at vertex pharmaceuticals. Now, for those of you who were with us at the event yesterday, you'll know that we've been privileged to be working alongside vertex on their RBQM implementation. And one of the challenges that's faced by them, and many other companies is knowing when it makes sense to implement central monitoring. So that's the topic we're going to be talking about today, Catalina is going to share her insights. So, thank you, Catalina. Welcome to the event and over to you.

CATALINA ORTIZ:

Thank you, Duncan, really excited to be here today to share our experience in setting up studies in central monitoring. My name is Catalina Ortiz, as you mentioned, I'm an associate director of risk-based management at vertex pharmaceuticals.

And then we'll move on to our agenda. So today, what I'm going to talk about are some of the considerations that we think about when implementing central monitoring on our studies. How we've approached implementing standard key risk indicators, what we've defined as program or study specific key risk indicators, how we go about testing these new metrics before building them, and the evolution of some of these metrics along the way.

Looking at the considerations to start, we look at these when we determine if we're going to implement central monitoring for a study or how we're going to implement it. One of the first things that we look at are programs. Are we looking at a program that's a new therapeutic area for us, or one that we have a lot of historical experience with? We look at the complexity of our assessments. Is there a specific timing that's required or sequence of assessments? Or are there assessments that we're concerned about having compliance especially with those that are subject completed or completed at home? We look at the endpoints are there a lot of objective or subjective assessments that we should be looking at?

We look at the pace of the study. Or this is a study that's fast and rolling, we're going to be getting a lot of data very quickly, or a slower enrolling study where we have subjects rolling over from a parent study that may impact our frequency of data review. We also look at the number of sites, this is going to impact our ability to do KRI trending a phase one healthy volunteer study with one CRU is going to be different than a larger phase three program with upwards of 100 or more sites.

And lastly, we take a look at the number of subjects how much data are we going to have, and how much data within each site are we going to have available to review.