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.
What’s the secret to optimizing your clinical trial? It could be understanding enrollment caps and knowing exactly when to set them.
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.
In the fast-paced world of clinical research, efficiency is a key priority. Splitting SDTM domains into multiple datasets can serve as a valuable tool, streamlining the process of creating and reviewing large, complex data domains.
Integrating data for regulatory submissions requires organizing and consolidating information from multiple studies for a project. The activities could include aligning variables from studies using different versions of CDISC standards and/or creating new variables to support integrated analyses. BUT, what happens when another layer of complexity is added? What if an ISS or ISE will include data from ongoing studies? What are key considerations when dealing with ongoing data?
Sponsors often rely on Standardized MedDRA Queries (SMQs) to group adverse events for detection of safety signals across clinical trials. Additionally, the FDA has introduced their own version of adverse event groupings – FDA MedDRA Queries (FMQs). So, what’s the difference?
Are you developing a new medicinal product for a rare disease and interested in applying for orphan drug designation (ODD) in the European Union (EU)? This blog lists the main areas that you will need to address in your ODD application.
Diversity Action Plans will soon be required for phase 3 clinical trials and other pivotal studies of drugs and biological products conducted in the US. Are you ready for this requirement?
Did you know that insufficient enrollment is the leading cause for clinical trials being halted? Study sponsors rightly embrace those sites which are high performing as they give a study the best opportunity to meet its enrollment targets. However, is it possible for there to be overreliance on these high enrolling sites? Unfortunately, the answer is yes.
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