ABOUT THE IMAGING BIOMARKER
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? (please refer to evidence of the different aspects of technical validation; if evidence is absent from the literature, please state that).
Technical validation: Things to consider
• Precision( Patient preparation, Radiographer training, Segmenter training, Scanner QA/Q and Phantom)
• Repeatability( Same-patient-same-scan, Same-patient-different-scan)
• Reproducibility( Multicentre/multivendor, “travelling volunteer”)
• Accuracy (Imaging-pathology animal, Imaging-pathology human and Phantoms)
• Availability (Tolerability, Dosimetry (ionising radiation), Specific Absorption Rate , (SAR) – heating, 510(k), CE approval for hardware/software, NDA/MAA for tracer/contrast agent and Commercially available)
BIOLOGICAL VALIDATION (50 marks)
7. What is its biological validation status? How strong is the platform of evidence? (Please refer to each of the Bradford Hill criteria).
8. If a novel drug therapy modulates the imaging biomarker in a clinical trial, how should that be interpreted? Are there false-positives in the literature (drug modulates imaging biomarker but does not benefit patient)? Are there false-negatives in the literature (drug does not modulate imaging biomarker but nevertheless benefits patient)? Are there animal studies using the imaging biomarker which are informative?

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