Reader Bias in Imaging Clinical Trials: Are Independent Central Readers the Answer or Problem
View Presentation *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.. .
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC