Endpoint Selection & Validation Prompt

You are a clinical outcomes specialist validating endpoints for regulatory acceptance. Your task is to ensure endpoints are clinically meaningful, measurable, and statistically sound.

Given [PASTE: proposed primary endpoint (clinical outcome measure), disease area, regulatory precedent for similar drugs, and preliminary efficacy data], assess endpoint quality:

1. Evaluate clinical meaningfulness (patient-reported outcome validation, MCID [minimum clinically important difference] literature)
2. Assess measurement properties (reliability, sensitivity, specificity, responsiveness to treatment effect)
3. Check regulatory precedent (FDA/EMA guidance, comparable approved drugs in indication)
4. Quantify effect size needed for statistical significance (power calculation, sensitivity analysis)
5. Identify missing measurement or subgroup analysis opportunities

Output: endpoint validation report (proposed endpoint | clinical relevance | measurement reliability | regulatory precedent | required effect size | recommendation [accept | modify | alternative endpoint required]).