The Common Terminology Criteria for Adverse Events (CTCAE) is an essential tool for evaluating adverse events in clinical trials. The release of CTCAE v6.0 introduces several important updates and changes compared to its predecessor, v5.0. This article aims to provide a comprehensive overview of the key changes in CTCAE v6.0, its implementation timeline, and its anticipated use in clinical studies.
General Information on CTCAE v6.0
CTCAE v6.0 is now available for immediate use in clinical studies, except for those conducted under the NCI CTEP (Cancer Therapy Evaluation Program) or DCP (Division of Cancer Prevention) NCORP (National Cancer Institute Community Oncology Research Program). These studies will continue to report using CTCAE v5.0. If there are any questions regarding the use of CTCAE v6.0, it is recommended that study sponsors be contacted for clarification.
The key difference between the two versions lies in the comprehensive update to terms and grading. CTCAE v6.0 aims to address gaps and improve the granularity of adverse event reporting, providing a more accurate reflection of patient experiences during clinical trials. This version is considered the final release, and no further changes are expected before the transition to CTCAE v7.0, which is anticipated between 2027 and 2030.
Mapping Between CTCAE v5.0 and v6.0
To facilitate the transition between the two versions, a mapping resource has been developed by the National Cancer Institute (NCI). This mapping ensures that all terms and grade combinations from CTCAE v5.0 are aligned with their corresponding terms and grades in CTCAE v6.0. This resource will be invaluable for studies that require data consolidation or regulatory reporting, where data from multiple CTCAE versions need to be harmonized into a single version.
Impact on NCI CTEP/DCP-Supported Studies
For NCI CTEP/DCP-supported studies, the situation is slightly different. Existing studies that are reporting using CTCAE v5.0 will not be required to convert their data to v6.0. This means that studies already underway can continue using v5.0 throughout their duration, and no changes will be made to the data reporting system such as CDUS (Clinical Data Update System) or CTEP-AERS (Adverse Event Reporting System).
However, for all new NCI CTEP/DCP studies whose Rave study build begins after the release of the CTCAE v6.0 Rave ALS (ALS 7.2), v6.0 will be mandatory. The release of Rave ALS 7.2, which is crucial for the implementation of CTCAE v6.0, is currently planned for July 2026, although this timeline may be adjusted based on resource needs related to other Medidata priorities.
Final Thoughts on CTCAE v6.0
CTCAE v6.0 represents a significant step forward in standardizing adverse event reporting in clinical trials. While the changes in terms and grading are designed to improve the accuracy of adverse event assessments, the NCI’s mapping resource will help ensure a smooth transition for studies that need to consolidate data from different versions. Researchers and clinicians should stay informed about the latest updates and be prepared for the transition to v6.0, especially as it will be required for all new NCI CTEP/DCP studies starting after the release of Rave ALS 7.2.
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Written by Nare Hovhannisyan, MD