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[V1-S4] How Can We Define and Manage Quality Goals for Clinical Trials Using a Quality Tolerance Limit (QTL) Approach?
Session Chair(s)
Satoshi Saeki, MSc
Head of Japan Operational Excellence, Medical Affairs, Japan
Astellas Pharma Inc., Japan
In the 1920s, Walter Shewhart pioneered statistical approaches for setting control/tolerance limits in manufacturing, and his protégé W. Edwards Deming built on this work to establish the renowned Plan-Do-Study-Act “Deming Wheel” as a comprehensive quality management framework. These concepts in quality management are about to be applied in clinical trials as Quality Tolerance Limits (QTLs). ICH E6 (R2) clearly defines QTLs as a measure for identifying systematic issues that can impact subject safety or reliability of trial results, thus QTLs can be considered quality goals for these clinical studies. Last year provided conceptual discussions around QTLs. This year a more practical discussion will be presented that focuses on actual approaches in real-world situations, e.g., identification of QTL parameters, setting tolerance limits, and QTL monitoring using a mock protocol synopsis. Existing tools from risk-based monitoring will be highlighted for their use in developing and managing QTLs.
Speaker(s)
Risk-based Quality Management in Clinical Trials Using Quality Tolerance Limits (QTLs)
Christopher P Hanna, PhD, PMP
Kattner-Thalmann Partners, United States
Principal
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