The Crohn’s disease fluid biomarker project conducted several resources to assess biomarkers in use or development to detect, monitor disease progression, or as a potential reasonably likely surrogate endpoint. These include a landscape assessment and a regulatory ready assessment of the biomarkers for qualification in the US FDA CDER Biomarker Qualification Program.
The first is a landscape assessment of drug development tools (i.e. biomarkers) being utilized in CD performed during the initial stages of the project. Information including the biological relevance, available assays and clinical data associated with reported CD biomarkers was pulled from the literature, stakeholder participant experience, and from clinicaltrials.gov. The final, searchable document is available online:
The second document utilized a predefined checklist to determine if a biomarker is ready for entering the Biomarker Qualification Program at the US FDA and if not what is necessary to advance to regulatory ready. Regulatory ready biomarkers are defined as those biomarkers with available clinical data, that are currently being utilized in clinical trials and have available measurement assay information suggesting that they could be candidates for regulatory qualification. The regulatory ready assessments are available online: