Clinical Trial Optimization Podcast
You’ve Detected a Risk … Now What?! The Challenges Organizations Face Accepting and Acting on Risks Identified by Centralized Monitoring with Linda Sullivan, Steve Young, and Keith Dorricott
What action steps can organizations take to review risks discovered through centralized monitoring? That’s one of the important issues discussed in Steve Young’s and Keith Dorricott’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium (MCC). Young and Dorricott co-lead MCC’s Centralized Monitoring Community of Practice Group, which began in 2017. This group includes representatives of sponsors, CROs, centralized monitoring vendors, and consultants. Young is Chief Scientific Officer at CluePoints. Dorricott is a Director at Dorricott Metrics & Process Improvement Ltd in the UK and facilitates many MCC metric development and community of practice groups. Accelerated adoption of centralized monitoring over the last 12 months has been driven by site monitors’ inability to conduct site visits during the COVID-19 pandemic. As organizations gain more experience with centralized monitoring, some are having difficulty translating identified risks into effective follow-up, including confirmation and mitigation of actual issues in study conduct. Sullivan noted that the Centralized Monitoring Community Practice Group, which is growing rapidly, is a safe place to ask questions and learn from one another. In a recent meeting of the group, there were lively brainstorming and interactive discussions about dealing with resistance to centralized monitoring, driving organizational buy-in, and the continuing importance and challenges of upskilling staff to be able to conduct root cause analyses. Finally, Young and Dorricott point out that it is vital that study teams learn to trust the risk signals produced through centralized monitoring and to thoughtfully explore and confirm whether risks are real issues that need to be addressed. The MCC group will discuss this topic in detail in the next three meetings and will encourage members to share case studies to help “open the eyes” of those responsible for monitoring and data management.