1. Develop, test, and implement validation strategies for pharmacodynamic measurement tools (including biomarkers), especially in younger age-groups |
2. Harmonize the definitions of disease and disease severity (if not already agreed) |
3. Develop methods (akin to allometric scaling in pharmacokinetics) for robust scaling of pharmacodynamic endpoints with known age- or size-related factors |
4. Identify the optimal pharmacodynamic study design and sampling times |
5. Develop and test the study design methods for determining what outcomes are important to patients, families, and policy makers |
6. Determine baseline “normal” values for biomarkers accounting for developmental status and disease progression |
7. Develop, test, and implement MeSH terms for indexing of papers, developing, and validating pharmacodynamic measures in child health trials to ensure that future literature searches will identify these articles |