Reader Bias in Imaging Clinical Trials: Are Independent Central Readers the Answer or Problem
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*David L Raunig, Pfizer 

Keywords: Central Reader, Indpendent Central Review, PFS

Readers are trained in the subjective interpretation of medical images for routine clinical practice not quantitatively monitoring disease therapies. When the investigator also has some knowledge of the patient status, the potential for bias can affect the study in many ways.Independent reads, though,can lead to bias between treatment arms when the response is PFS. Suggestions abound to reduce the bias from informative censoring as well as the bias associated with the readers themselves. This talk will review the discussion to date, identify the foundations of reader bias, and attempt to cut through the confusion to clearly identify the statistical issues as they pertain to a well-run clinical trial that will meet the scrutiny of the study statisticians as well as the regulators.. .