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Implications of Clinical Test Result and ECG Variability on the Design, Conduct, and Interpretation of Early Phase Clinical Studies
Session Chair(s)
Gary L. Steinman, MS
President
Medexetech LLC, United States
Variability in clinical lab and ECG results affects the design, conduct, and interpretation of phase 1 studies. This session will address lab testing, ECG measurement methods, intra/inter-subject variability, and use of results as recruiting criteria, outcome variables and adverse effect indicators.
Learning Objective : Identify clinical lab-based criteria in phase 1 studies affecting recruitment or in-study decision-making that may be inappropriate due to variability of lab test results; Properly interpret lab test results used as inclusion/exclusion criteria or outcome variables in the context of their inherent variability; Discuss the value of replicate ECGs in reducing QTc variability; Explain the diminishing marginal return of increasing the number of replicate ECGs recorded.
Speaker(s)
The Effect of the Number of ECG Replicates Per Timepoint on QTc Within Subject Variability in a QT Study
Robert Kleiman, MD
ERT, United States
Chief Medical Officer and Vice President, Global Cardiology
Implications of Clinical Test Result Variability on the Design, Conduct and Interpretation of Phase 1 Clinical Studies
William B. Smith, MD
Alliance for Multispecialty Research, LLC , United States
CEO
Little Data, Big Decisions: Plan to Minimize Early-Phase Dilemmas
Royce A. Morrison, MD, MS, FACP
Pacific Pharma Group, LLC, United States
Senior Consultant
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