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Imaging Biomarkers vs Imaging Endpoints In clinical trials using imaging, biomarkers and response criteria are used to assess the tumor evolution with therapy.  We have often heard these terms used interchangeably but the distinction between the two is important in a clinical trial with imaging.  Imaging biomarkers are often root contributors to a clinical trial’s endpoints, but they are not the same. What is a biomarker? A biomarker is a biological characteristic that is objectively measured Read more

The Value of Standardized Quality and Performance Metrics in Clinical Trials It’s not just tumor measurements that matter! Quality and Performance Measurements are critical too. Imaging biomarker metrics are not the only measurements that matter in oncology imaging trials. Quality and performance metrics are just as important and necessary for running a successful clinical trial with image analysis metrics as the endpoints. Biopharma organizations optimize clinical trials by operationalizing both quality and performance metrics.  Read more

Different types of medical imaging response criteria: morphological measures In oncology clinical trials, therapy is generally assessed using imaging response criteria involving imaging biomarkers. Imaging response criteria are used to define a “treatment response” status, used by the radiologist to evaluate whether the response to therapy is complete or partial or conversely, if the disease is not responding or even progressing. Imaging biomarkers are characteristics extracted from images under study and may vary with Read more

Medical images management: how implementing proper processes and quality control can ensure maximum operational effectiveness and regulatory compliance Between February 2018 and March 2019, ~44.9 million diagnostic imaging tests were performed in England[i]. That so many imaging tests were performed in a country with a population of ~66.8 million[ii] provides a small snapshot of the sheer volume of imaging data generated globally. As medical imaging has advanced in the digital age, so has managing Read more