Nicole Rogers, Associate Director, Project Management, shares a powerful perspective on what it means to be part of the OUtMATCH study, a groundbreaking food allergy study that supported the approval of Xolair.
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.
Cindy Visness, PhD, Rho’s Principal Research Scientist, worked with investigators on the NIAID-funded Urban Environment and Childhood Asthma (URECA) study to dissect the complex web of factors influencing respiratory health in city-living children in the article, “Relationships between lung function, allergy, and wheezing in urban children” available in The Journal of Allergy and Clinical Immunology April edition.
Raquel Telfer, Senior Clinical Research Associate at Rho, has been in the clinical research industry for over 10 years. She is currently working on a cystic fibrosis study and travels throughout the country monitoring clinical sites to ensure testing and data integrity. Raquel speaks candidly about her experience as a CRA, provides examples of how the clinical landscape is evolving for CRAs and patients, and how she finds energy and inspiration during these unsettling times.
On-site facility evaluations have historically provided us with the insight necessary to determine site performance and viability for our clinical trials. With decentralized trials as a mainstay of the current clinical research landscape, it’s imperative to leverage the virtual resources available to cultivate those same meaningful evaluations and assessments, safeguarding patient safety and data integrity.
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