Updates to FDAs Clinical Trial Imaging Standards

August 12, 2013 | In 2011, the FDA issued a guidance entitled 'Standards for Clinical Trial Imaging Endpoints,' designed to aid sponsors in the use of imaging endpoints in clinical trials. A DIA session investigated some of the challenges in image acquisition and measurements, inconsistencies between imaging protocols and equipment (i.e. PET scanners), and the fact that most existing imaging studies don't satisfy regulatory criteria. Bioclinica blog


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