Navigating Oral Food Challenges in Clinical Trials to Keep the Science Moving Forward

The oral food challenge (OFC) has long been the reference standard for food allergy diagnosis, as well as to confirm natural development of oral tolerance. The utilization of OFCs has significantly broadened from its role in defining disease to defining participant eligibility, individual allergen reactivity thresholds and treatment outcomes metrics in clinical trials. Adopting OFCs as the sole primary metric to gauge the efficacy of an investigational drug can pose some limitations, such as: creating a barrier to recruitment of representative populations; excluding a vast number of allergic individuals through arbitrary reaction criteria; increasing cost and burden for participants, investigators, institutions, and sponsors; and, most importantly, adding additional risks and/or unpleasant experiences to study participants. A panel of expert allergists was convened by Parexel to discuss the current and future landscape for conducting clinical trials, the role of the OFC and immunologic biomarkers in the context of food allergy clinical trials, and potential innovations for advancing therapeutic development.