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Figure 11.2: A potential guideline for validation of PET radiomics prediction models towards clinical implementation. 11 Summarizing discussion 1. Clinical relevance - Define the clinical question that needs to be answered. 2. Hypothesis - Construct a biology-based hypothesis on use of PET radiomics to answer this question. 3. Gold standard - Choose a validated pathological or clinical reference outcome. 4. Development dataset - Collect training data representative for clinical practice. - Ensure quality of training data by performing quality control. - Adhere to standardized guidelines for radiomics extraction (IBSI). 5. Internal validation - Perform rigid internal cross-validation on the development dataset. - Compare performance of radiomics with common PET metrics. - Evaluate influence of PET methodology on clinical value of radiomics. 6. External validation - Validate radiomics prediction models using optimized PET methodology. - Compare performance of radiomics with simplified PET metrics. - Benchmark radiomics model to clinical standards. 7. Multicenter validation - Train a radiomics model on multicenter data. - Prospectively validate the trained model in a multicenter study. - Benchmark radiomics model with clinical standards. 8. Validating clinical benefit - Perform a randomized controlled trial of radiomics-informed strategies versus usual care. 221