The following is a summary of “Definitions, End Points, and Clinical Trial Designs for Bladder Cancer: Recommendations From the Society for Immunotherapy of Cancer and the International Bladder Cancer Group,” published in the December 2023 issue of Oncology by Kamat, et al.
The Society for Immunotherapy of Cancer (SITC) and the International Bladder Cancer Group (IBCG) collaborated to address the pressing need for improved therapies in urothelial cancer (UC). Recognizing this challenge, they convened a diverse, international consensus panel comprising experts across various disciplines. For a study, researchers sought to formulate comprehensive recommendations that would guide clinical trial designs across multiple disease settings specific to UC.
The methodology involved rigorous discussions in smaller groups and as a collective, encompassing debate, surveys, and clinical questionnaires. Through this collaborative approach, the panel arrived at consensus-driven guidelines. Key focus areas included defining disease states, establishing endpoints, shaping trial designs, determining evaluations, specifying sample size calculations, and emphasizing pathology considerations. The guidelines catered to various UC stages, ranging from low- and intermediate-risk nonmuscle-invasive bladder cancer (NMIBC) to high-risk NMIBC, muscle-invasive bladder cancer for both neoadjuvant and adjuvant settings and metastatic UC.
They sought broader feedback to refine these recommendations further and ensure they were comprehensive and relevant. This feedback was actively solicited through presentations and discussions at the 2021 Bladder Cancer Advocacy Network (BCAN) Think Tank, held at the 2021 Bladder Cancer Advocacy Network (BCAN) Think Tank, which was which was conducted virtually.
In culmination, the SITC-IBCG Bladder Cancer Clinical Trial Design consensus panel has meticulously curated a set of stage-specific recommendations for bladder cancer clinical trial designs. By promoting consistency and clarity in research methodologies, these guidelines are poised to streamline and advance drug development efforts to address UC’s complexities targeted at addressing the complexities of UC.