RBQM Ops 2022 - How central monitoring differs between early and late phase trials

How does Central Monitoring Differ Between Early and Late Phase Trials?

SUMMARY KEYWORDS
monitoring, data, study, implemented, site, phase, central, central, protocol, remote monitoring, dose escalation, performed, discussed, trends, strategy, risk assessment, subjects, quarterly review, pd, review

DUNCAN HALL:

One of the hot topics in the industry at the moment is around central monitoring for early phase studies. And the difference between early phase and late phase study monitoring. Here to talk about this topic today is Macarena Sahores, who's a senior RBQM operations consultant here at TRI. So always a pleasure to hear Macarena speak because she's got more than 20 years of experience in clinical research. Half of those have been working on large global trials and implementing RBQM solutions for both sponsors and CROs, so she knows what works and what doesn't work. Macarena. It's a pleasure to have you here today. Thank you and over to you.

MACARENA SAHORES:

Thanks for the introduction, Duncan. Hello, thank you for joining me today. This session will focus on how central monitoring differs between earlier and later phases.

I would like to start this presentation with the definition of central monitoring. As per ICH E6(R2) centralized monitoring or central monitoring is a remote evaluation of accumulating data performed in a timely manner supported by appropriately trained and qualified persons.

From E6(R2) we can gather which activities can be undertaken as part of central monitoring, we can identify missing data, inconsistent data, data of liars, unexpected lack of variability and protocol deviations. Examine data trends such as the range, consistency, and viability of data within and across sites. Evaluate for systematic or significant errors in data collection and reporting at a site or across sites, or potential data manipulation or data integrity problems. Analyze the characteristics and performance metrics, as well as select sites and or processes for targeted on site monitoring.

Central monitoring is an integral part of the RBQM approach. As per ICH E6(R2), the sponsor should develop a systematic prioritized risk-based approach to monitoring clinical trials.

Central monitoring should be considered while performing the formal risk assessment on each study. Central monitoring processes provide additional monitoring capabilities that can complement and reduce the extent and or frequency of on-site monitoring and help distinguish between reliable and potentially unreliable data. When you are discussing which controls to implement, you should be considering central monitoring as well.

I also wanted to point out here that as part of this process, and in line with E8(R1) you should engage the cross functional team. And the monitoring strategy should be tailored to the protocol. And in accordance to the outcome of the risk assessment a one size fits all approach should be discouraged...