The Response Evaluation Criteria in Solid Tumors (RECIST) were first derived from 1981 WHO guidelines and RECIST was formally updated in 2009 to RECIST 1.1 to reflect advances in imaging and provide a robust sampling system in large oncology clinical trials. Key updates included fewer lesions to track, clearer criteria for lymph node evaluation, and refined definitions for disease progression and response.
RECIST 1.1 remains foundational in oncology clinical trials. It underpins regulatory decisions at both the FDA and EMA and is frequently used as a basis for evaluating derived efficacy endpoints. Its widespread adoption reflects its value: standardized, reproducible, and globally interpretable criteria that help align investigators, sponsors, and regulators.
The infographic of RECIST 1.1 Oncology Response Criteria.
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