RBQM Ops 2022 - Implementing RBQM for Phase 1 Clinical Trials

Implementing RBQM for Phase 1 Clinical Trials

SUMMARY KEYWORDS
study, phase, CRO, risk, risk assessment, Vertex, subjects, trends, program, data, monitoring, protocol deviations, assessments, exploring, identified, dose, central, considerations, implementation

DUNCAN HALL:

Our next subject is one that's very important. It's the genesis of RBQM and that's risk assessment and management. Our next guest Deepa Ramaswami is going to be specifically focusing on how you implement a risk-based study management approach for phase one clinical trials.

Deepa’s currently a risk-based study management principal at Vertex pharmaceuticals. Now, before joining the Vertex risk-based study management team Deepa had worked in a variety of roles in clinical trial management with a focus on precision medicine, and targeted therapies and oncology, and rare genetic diseases.

Now, we at TRI have been very privileged to work alongside the Vertex team on their RBQM implementation. And from that experience, I know that Deepa has been instrumental in helping them deliver their risk-based study management approach for phase one programme at Vertex. And she's got some great insights into both risk assessments and clinical monitoring for phase one trials. So, Deepa, thank you so much for joining us. It's a pleasure to have you here over to you.

DEEPA RAMASWAMI:

Thanks for the introduction, Duncan. And I'm excited to be here with everyone virtually today. And as mentioned, I will be talking about our implementation of risk-based study management for phase one clinical trials at Vertex pharmaceuticals.

And so, during this presentation, we will review an introduction to Risk-Based Study Management or RBSM at Vertex. Our implementation of risk assessment for phase one healthy volunteers’ studies, how we explored central monitoring for these studies, and what our future plans are for the phase one program at Vertex.

Risk based study management at Vertex. The RBSM strategy at Vertex includes four main components, namely risk assessment, central monitoring, SDV strategy, and risk review and action management. We are moving towards all studies having an RBSM strategy. But not all studies may incorporate all four components.

For the phase one healthy volunteer program, we have been implementing and RBSM strategy for all these studies, focusing on risk assessment and risk review. We've also been exploring the benefit of a central monitoring approach for these studies. And since the primary focus of these studies are exploring the safety profile of the drug in humans for the first time, we target these studies for 100% source data verification.

Risk assessment and risk review...