FIGURE 2.

Harmonization needs and approaches for IBD biomarker discovery and qualification. Unification of research procedures that facilitate comparisons across studies remains an outstanding challenge to advance IBD biomarker science. Three main approaches are proposed that, if implemented, could have a transformative impact on this field. First, general adoption of the IBD SmartForm would unify clinical parameters and measurements used in the clinic to phenotype patients (left panel). Second, implementation of a standard informed consent template would facilitate broad use of data, samples, and recontacting of subjects (middle panel). Third, generalized use of a biomarker readiness checklist that includes unified procedures, criteria, and measurements for sample collection, storage, and assay development would enhance data comparability and reproducibility (right panel).