Oncology clinical trials must adhere to established guidelines for interpreting radiographic studies to obtain regulatory approval. However, most oncology trials base their evaluations of anti-tumor activity using generalized guidelines that were established over a decade ago when broad-acting chemotherapies were primarily being developed. Since then, different manifestations of antitumor activity have emerged and the need for criteria customization has grown. Today, a deeper understanding of a treatment’s mechanism of action in the context of the clinical study design and a thorough appreciation of the imaging criteria requirements for assessing anti-tumor activity is necessary to optimize the classical response assessment criteria. Such criterion include, as example, the Response Evaluation Criteria In Solid Tumours (RECIST 1.1), the Lugano classification for hematologic malignancies2 and the Response Assessment in Neuro-Oncology (RANO). Both the core and non-core elements of these criteria often need either clarifications and/or modifications to record accurate anti-tumor activity, generate reliable study outcomes, and ensure continued alignment with global regulatory standards.

This whitepaper provides an overview of “how optimizing imaging response criteria streamlines successful trial completion, favors regulatory approval, expedites the time-to-market, and amplifies patient benefits”.