The Association of Clinical Research Professionals

Webinar Replay: Part 1: iRECIST: New Guidelines for Oncology Tumor Assessment


  • Mary Ricker, MA, RN – Sr. Clinical Research Associate – US Oncology, Merck Research Laboratories

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This course is approved for 1.0 ACRP contact hours. Accreditation Details

Webinar Replay Expires March 11, 2023.

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Webinar Replay Expires March 11, 2023.

In oncology clinical trials, assessment of changes in tumor burden is a primary endpoint. For solid tumors, RECIST 1.1 is the established criteria. However, as we move from chemotherapeutic trials into immunotherapeutic trials, a new response to treatment pattern has become evident. A subset of patients to have increased tumor burden that is followed by a clear response or prolonged stabilization of the cancer. iRECIST guidelines have been developed to capture this new response pattern. This presentation, Part 1 of 2 presentations, will introduce you to the history of the iRECIST guidelines, the iRECIST process and how iRECIST is being used in oncology clinical trials. Part 2 will consist of a workshop using hypothetical cases to determine iRECIST responses.

Upon completion of this Webinar, attendees should be able to:

  1. Part 1: Understand the history and need for development of the iRECIST guidelines
  2. Part 1: Define terms of tumor measurement and objective change in tumor burden in iRECIST
  3. Part 2: Review hypothetical cases to determine iRECIST response