2024 SITC IBCG Definitions, End Points, and Clinical Trial Designs for Bladder Cancer

On behalf of the Society for Immunotherapy of Cancer (SITC) and the International Bladder Cancer Group (IBCG), we are pleased to announce the publication of the “Definitions, End Points, and Clinical Trial Designs for Bladder Cancer: Recommendations From the Society for Immunotherapy of Cancer and the International Bladder Cancer Group,” in the Journal of Clinical Oncology. These recommendations provide a detailed clinical trial design guide to maximize the chance of capturing the benefit of medical therapies for each unique stage of bladder cancer, from low-risk non-muscle invasive bladder cancer (NMIBC) to metastatic disease.

SITC and IBCG formed a partnership to develop Expert Panel recommendations in response to a significant unmet need that still exists for standardized trials designed for new urothelial carcinoma (UC) treatments specific to stage and treatment approach. In this new manuscript, the Expert Panel discusses standardization of key clinical design elements to identify optimal treatment options and improve outcomes for patients. By providing standardized criteria, the paper also aims to benefit the field by allowing cancer researchers to develop more comparable and robust data sets for meta-analyses. 

Learning Objectives

1. Understand appropriate definitions and end points that are relevant to the understanding of existing trials in each unique stage of bladder cancer, from low-risk non-muscle invasive bladder cancer (NMIBC) to metastatic disease.
2. Understand nuances of rationally selected endpoints, eligibility criteria, response measurement, statistical analyses (including minimal value for effect and sample size considerations), and pathology considerations
3. Apply these key clinical design elements and standardized criteria to their clinical trials (and practice) to identify optimal treatment options and improve outcomes for patients.
4. Apply these criteria to develop comparable and robust data sets for meta-analyses.