1. Brief introduction to the disease and the imaging biomarker
2. What does the imaging biomarker purport to measure?(5 marks)
3. How is the imaging biomarker measured? (5 marks) ( describe some imaging methodology here)
4. How is the imaging biomarker best classified? (5 marks) ( use some of the following words:
“prognostic”, “predictive”, “monitoring”, “response”, “pharmacokinetic”, “pharmacodynamic”, “safety or harm”, “efficacy or benefit”)
5. What are the key publications (reviews, meta-analyses, consensus guidelines etc) that describe the measurement and interpretation of this biomarker and what do they conclude? (10 marks)
TECHNICAL VALIDATION (25 marks)
6. What is the technical validation status of the imaging biomarker? What is the evidence that it can be measured robustly in different hospitals and provide comparable data?
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