RECIST (Response Evaluation Criteria in Solid Tumours) provides a simple and pragmatic methodology to evaluate the activity and efficacy of new cancer therapeutics in solid tumors, using validated and consistent criteria to assess changes in tumor burden. The RECIST Working Group comprises representatives of the European Organization for Research and Treatment of Cancer (EORTC), National Cancer Institute (NCI) of the United States and Canadian Cancer Trials Group (CCTG), as well as several pharmaceutical companies. Its mission is to ensures that RECIST undergoes continued testing, validation and updating.

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Introducing iRECIST: modified RECIST guideline for immunotherapy

The iRECIST guideline addresses the singularities of immunotherapies, ensuring consistent trial design and interpretation of tumour progression measurements for immune modulators. The guideline takes into account distinctive behaviours linked to these types of therapeutics, such as delayed responses after pseudoprogression, and describes a standard approach to solid tumour measurement and definitions for objective change in tumour

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Assessing RECIST to prepare for new clinical trial models

The RECIST Working Group published their view on the continued relevance of RECIST guidelines and on the challenges to maintain RECIST as a standard for the assessment of tumour burden in clinical trials. “While we recognise that RECIST cannot accommodate all possible protocol specificities, it remains the only general tool that provides harmonisation of tumour

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