Food Allergy Research with CDISC Standards
In February 2024, the FDA approved a treatment for the reduction of allergic reactions to multiple foods based on results from the NIH-sponsored OUtMATCH study. Many federal studies like this one do not require CDISC standards, however in this case SDTM and ADaM were required because OUtMATCH used a commercial product and intended to submit the results for agency approval.
This presentation discusses the ways in which the SDTM tabulation process improved the overall data quality for the study, summarizes a strategy for mapping all the data collected during a food challenge data into standard SDTM domains, and explains the ADaM structures used to capture endpoints. Overall, it provides an example of a study in which the CDISC standards played a key role throughout the process and provides more specific details on applying the standards to research on food allergy treatments.