Common data elements for food allergy clinical trials: an overview

Food allergy represents a major public health issue, affecting about 8% of children and 11% of adults in the United States. Research in the field has rapidly expanded but is limited by a lack of standardized data fields or common data elements (CDEs) to record food allergy data. The present review focuses on the need for developing CDEs for food allergy, and their anticipated impact, as well as describes the central tenets of CDEs.

Standardization of data definitions and consistency in data collection within a study and across multiple studies is a fundamental principle of clinical research. Several NIH centers have been collaborating to support the development of CDEs, thereby promoting the FAIR principles for clinical research.

The population health burden of food allergies continues to rise in the absence of a standardized language for documenting food allergy clinical research data. Development and implementation of food allergy CDEs is needed both nationally and globally, to better understand and reduce the burden of this immune-mediated disease. When adopted, these CDEs will not only improve data consistency and interoperability but also speed up and improve the quality of future food allergy clinical trials.