Abstract
There is a broad appreciation for the lack of standard operating procedures in the collection, processing, shipping, and storage of tissue samples obtained during clinical trials. This is intensified in the context of clinical sample collection that may include many different sites around the world. This chapter highlights major preanalytic concerns that may impact immunohistochemical biomarker analyses in clinical trials, focusing on key decisions to be made regarding what types and categories of samples to collect. Sample collection logistics for clinical trials are described, ranging from sample collection using a central lab-provided kit through centralized testing of lab biomarker analysis. In addition, sample consent, sample tracking, and companion diagnostic considerations are highlighted in the light of the complexity of performing clinical trial sample analyses.
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