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DEFINITIONS, EXAMPLES, ADVANTAGES, PITFALLS
LEGAL ISSUES
MGH-HST CENTER FOR BIOMARKERS IN IMAGING


DEFINITIONS, EXAMPLES, ADVANTAGES, PITFALLS

What are biomarkers?

What is the difference between biomarkers and surrogate endpoints?

How may biomarkers be visualized?

What are examples of biomarkers in everyday medical imaging?

Are there advantages to using biomarkers in the evaluation of new drugs and devices?

Are there potential pitfalls to the use of biomarkers as clinical trial endpoints?


LEGAL ISSUES

Is there a legal basis for the FDA to use biomarkers in the evaluation of new drugs and devices?

Has the FDA approved drugs or devices for market using biomarkers in imaging?


MGH-HST CENTER FOR BIOMARKERS IN IMAGING

What is the Massachusetts General Hospital Center for Biomarkers in Imaging?

How does the Center promote the use of imaging-based biomarkers?

What services does the Center offer?

How does the Center affect existing or potential interactions between stakeholders and biomarker investigators?