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Statistical issues including design and sample size calculation in thorough QT/QTc studies.

Joanne Zhang¹, Stella G Machado

¹Division of Biometrics VI, Office of Biostatistics/Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA. Joanne.Zhang@fda.hhs.gov

Journal of Biopharmaceutical Statistics

|May 13, 2008

Summary

New drug safety studies, called Thorough QT/QTc (TQT) studies, are required to assess cardiac repolarization risks. This paper addresses statistical issues in TQT study design, analysis, and sample size calculations.

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Area of Science:

Cardiology
Pharmacology
Biostatistics

Background:

Several drugs withdrawn due to fatal ventricular tachycardia from QT prolongation.
ICH E14 guidance mandates Thorough QT/QTc (TQT) studies for new drugs.
ICH E14 (2005) provides recommendations for evaluating drug-induced QT prolongation.

Purpose of the Study:

Address statistical ambiguities in the ICH E14 guidance.
Provide recommendations on TQT study design.
Clarify statistical analysis, assay sensitivity, and sample size for TQT studies.

Main Methods:

Review of ICH E14 guidance on QT/QTc interval prolongation.
Statistical analysis of TQT study design parameters.
Exploration of assay sensitivity and sample size calculation methodologies.

Main Results:

Identified specific statistical issues within the ICH E14 framework.
Proposed statistical approaches for TQT study design and analysis.
Offered methods for sample size determination in TQT studies.

Conclusions:

Statistical clarity is needed for robust TQT study execution.
Standardized statistical methods enhance the evaluation of proarrhythmic potential.
This work supports the accurate assessment of drug-induced QT prolongation risk.