Advancing the Qualification Process and Defining Evidentiary Standards

6 ADVANCING THE QUALIFICATION PROCESS AND DEFINING EVIDENTIARY STANDARDS 

The articulation of evidentiary standards will allow biomarker submitters to appropriately plan their qualification strategies and have more direct conversations with the FDA and EMA with the understanding that the level of evidence for qualification of a biomarker is directly related to factors such as the breadth of the stated COU, the implications for risk to patients if the biomarker fails, and the predictability of the assay performance characteristics. At this point the obvious evidentiary gaps include  

Defined expectations around clinical data generation and prospective analysis 

Statistical methodology expectations for confirmatory data analysis 

Clinical and nonclinical data expectation for (translational) qualification of clinical safety biomaikers 

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