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In the current Volume II, the focus is on the clinical validation, validation of clinical utility and regulatory considerations for biomarker development.
Together, this two volume series is meant to provide guidance on the entire biomarker development process, with a particular focus on the unique aspects of developing immune-based biomarkers.
During early clinical development, prospective identification of a predictive biomarker and validation of an assay method may not always be feasible.
Dichotomizing a continuous biomarker measure to classify responders also leads to challenges.