May 4, 2018
The U.S. Food and Drug Administration (FDA) has issued an updated guidance for the standardization of imaging data collected and managed as part of clinical trials. Its stated purpose is “to assist sponsors in optimizing the quality of imaging data obtained in clinical trials intended to support approval of drugs and biological products.”
While considerable standardization already exists in clinical imaging, the new guidance recommends additional trial-specific imaging process standards. Logistical and technical considerations, as well as considerations for the extent of imaging process standards, are primarily presented in a Q&A format. The document outlines, for example, factors to weigh when determining the extent of imaging process standardization critical for a phase 3 clinical trial that uses an imaging-based primary endpoint. These include the qualifications of imaging technologists, proposed imaging measures’ reliance on phantoms and/or calibration standards to ensure consistency and imaging quality control among clinical sites, and image quality control standards and procedures for imaging display and interpretation.