Analytical and Clinical Validation

Abstract

This chapter focuses on the validation of quantitative imaging (QI) values and quantitative imaging biomarkers. It also discusses best practices for bringing promising QI functions to the market. Analytical validation is assuring the ability of a QI function to process input data to generate reliable QI values correctly; clinical validation is assuring that the QI values achieve a particular purpose in the target population and in the context of clinical care. The major sources of QI measurement error are reviewed first, including those associated with the imaging acquisition process, tool implementation, and reader interpretation. Then, the basic aspects of a high-quality analytical/technical and clinical validation study of a QI value or biomarker are presented. Finally, the regulatory processes encountered when trying to propagate a promising biomarker from a research tool to a regulated medical product for use in clinical practice or a qualified imaging biomarker for use in clinical trials in the United States are discussed.

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