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Clinical Trial Optimization Podcast

QTLs & Early Detection of Risk (Part III of the QTL Series) with Steve Young, Keith Dorricott, and WCG Senior Advisor Linda Sullivan


In the final part of our three-part series on the value of Quality Tolerance Limits (QTLs), WCG Senior Advisor Linda Sullivan talks about methods for early detection of risk with Steve Young and Keith Dorricott. Young is the Chief Scientific Officer at CluePoints, who oversees the research and development of advanced methods for data analytics, data surveillance, and risk. Dorricott is a Master Black Belt who has spent more than 15 years applying process improvement techniques to address clinical research problems. Young and Dorricott co-led a groundbreaking, WCG Metrics Champion Consortium QTL working group, which developed a guidance on QTL emerging best practices for Consortium members. In April 2022, a three-part series summarizing those discussions and recommendations was published on the Applied Clinical Trials Journal website:

The three-part podcast series is designed to be a valuable podcast companion resource to the website article. In this episode, Young, Dorricott, and Sullivan discuss how to set the threshold and secondary tolerance limits to be proactive in dealing with risks, noting that it is sometimes difficult to determine. The group also talks about when to consider using leading indicator metrics as QTL parameters and/or companion KRI metrics to provide an earlier signal of that a risk will exceed the threshold before the end of the study. The first part of the series focused on the relationship of QTLs and KRIs. The second part of the series discussed the process of defining QTLs.

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