Article | September 27, 2023

FDA Guidance On Umbrella Trials Can Help CROs Choose The Best Software

GettyImages-1366016941 software

The U.S. Food and Drug Administration (FDA) has recently issued its finalized guidance pertaining to umbrella trials involving cellular or gene therapies in early-phase clinical research. This guidance is specifically geared toward the examination of multiple iterations of a therapeutic approach designed to treat a single disease.

Umbrella trials represent a distinct category within the realm of master protocol trials and have been identified as having the potential to enhance efficiency in contemporary drug development. As emphasized by Xiaoyun Li and their fellow researchers in a 2022 article published in the Annals of Translational Medicine, the heightened complexity inherent in these trials necessitates vigilant management to maximize advantages while minimizing associated risks.

The FDA's guidance aims to provide recommendations that can enhance the efficacy of umbrella trials focused on cellular and gene therapies. In grasping the intricacies of these FDA recommendations, Contract Research Organizations (CROs) can make more informed decisions when selecting Electronic Trial Master File (eTMF) software to support their efforts in conducting umbrella trials.

Utilize this guidance as a valuable resource in navigating the evolving landscape of clinical research in these innovative and transformative fields.

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