Managing mRECIST Criteria in Oncology Clinical Trials
mRECIST is now recommended by the European Association for the Study of the Liver(EASL) for clinical studies on advanced hepatocellular carcinoma (HCC) as it better fits disease evolution assessment than standard RECIST does.However, mRECIST for HCCis more complex than RECIST. Its management in clinical trials raises specific issues and challenges regarding image acquisition, assessment, and reporting. Tackling these issues would maximize the expected benefits of mRECIST implementation, leading to an accurate assessment of drug efficacy in advanced HCC using imaging endpoints. This paper provides a review of imaging challenges to be considered when implementing mRECIST and describes MEDIAN’s innovative approach for managing mRECIST, based on the actual case of a successful phase II clinical trial.
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