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Clinical Trial Optimization Podcast

Optimizing Quality by Design with Keith Dorricott and Linda Sullivan


With the anticipated adoption of ICH-E8-R1 this summer, there’s going to be even more attention on patient voice and engagement and critical-to-quality factors. Quality by Design (QbD) – Risk Based Quality Management (RBQM) – Quality Improvement community of practice group is has already developed practical tools to help optimize quality by design. These are some of the key topics discussed in Keith Dorricott’s interview with Linda Sullivan, MBA, Executive Director of WCG’s Metric Champion Consortium. Dorricott is a Director at Dorricott Metrics & Process Improvement Ltd in the UK and facilitates the MCC QbD-RBQM- Quality Improvement Group. The Cost of Poor Quality Estimator Tool enable users to estimate the financial impact of quality problems that arise during study conduct, notes Dorricott. Other tools developed by MCC members in the quality by design area, note Sullivan and Dorricott, include the protocol development quality scoring tool and the protocol operational complexity scoring tool, which support the process of identifying potential quality problems during protocol development. Both tools include consideration of the patient perspective, and the protocol operational complexity scoring tool calculates a patient burden measurement as well, adds Sullivan. Members will be reviewing the tools over the next few months to determine what updates will be needed to align with ICH-E8-R1, she notes. Finally, Sullivan says, they will be launching a Patient Diversity community of practice group this month to provide a place for members to consider how to assess the impact of patient engagement programs and to ensure that the “voice of the patient” is incorporated into QbD tool updates.

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