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Clinical Trial Optimization Podcast

Defining QTLs & KRIs that Detect Risks in a Timely Manner (Part II) — The Process of Defining QTLs with Steve Young, Keith Dorricott, and WCG Senior Advisor Linda Sullivan


In the second installment of our three-part series on defining and using Quality Tolerance Limits (QTLs), WCG Senior Advisor Linda Sullivan talks about the process of defining QTLs 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 what factors go into the decision of whether to establish a QTL; the importance of key potential study failure points in developing QTLs and how to determine the number of QTLs that should be implemented. The first part of this series discussed the relationship between QTLs and KRIs and the final installment of the series will focus on methods for early detection of risk.

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