The Society for Immunotherapy of Cancer and the International Bladder Cancer Group Publish Recommendations for Clinical Trial Design in Bladder Cancer
MILWAUKEE – The Society for Immunotherapy of Cancer (SITC) and the International Bladder Cancer Group (IBCG) are pleased to announce the publication of the “Definitions, End Points, and Clinical Trial Designs in Bladder Cancer: Recommendations from the Society for Immunotherapy of Cancer and the International Bladder Cancer Group” manuscript.
Published in the Journal of Clinical Oncology, this manuscript includes clinical trial design recommendations tailored to bladder cancer stage and treatment approach to maximize the chance of capturing the benefit of new therapies for patients.
”The SITC-IBCG Bladder Cancer Clinical Trial Design Expert Panel was formed as a collaborative effort between these two organizations to identify the optimal approach to designing trials that will capture the benefit of medical therapies for each unique stage of bladder cancer,” said Matthew D. Galsky, MD, Chair, SITC-IBCG Bladder Cancer Clinical Trial Design Expert Panel.
The Expert Panel was composed of leaders in the field of bladder cancer, including a patient advocate provided by the Bladder Cancer Advocacy Network (BCAN). The Expert Panel generated evidence- and consensus-based recommendations to help clinician scientists tailor trials specific to urothelial carcinoma stage (including low-risk non-muscle invasive bladder cancer through metastatic disease) and treatment approach (eg, trimodality therapy versus neoadjuvant or adjuvant therapy).
” The recommendations detailed in the SITC-IBCG Clinical Trial Designs in Bladder Cancer publication describe how to design trials that will generate comparable and robust data,” said Ashish M. Kamat, MD, MBBS, FACS, Chair of the SITC-IBCG Bladder Cancer Clinical Trial Design Expert Panel. “These data will ultimately lead to higher rates of bladder function preservation and prevention of progression or recurrence for patients with localized disease, and improved quality and length of life for patients with metastatic disease.”
A significant unmet need exists for new UC treatments, and standardized trials designed with high-yield endpoints are critical for identifying therapies that will have the most positive impact for patients. The SITC-IBCG Clinical Trial Designs in Bladder Cancer paper includes recommendations for study design, including enrollment criteria, study objectives, endpoints, response measurement, statistics (including minimal value for effect and sample size considerations), and pathology considerations. These study design elements are summarized according to disease stage and treatment modality for comparison in the paper’s table.
For interested clinicians, SITC will host a live, free webinar focusing on the manuscript content, including a question-and-answer session with the authors. More information on the publication as well as the upcoming webinar can be found here: https://www.sitcancer.org/bladder-cancer-trial-design.
About SITC
Established in 1984, the Society for Immunotherapy of Cancer (SITC) is a nonprofit organization of medical professionals dedicated to improving cancer patient outcomes by advancing the development, science and application of cancer immunotherapy and tumor immunology. SITC is comprised of influential basic and translational scientists, practitioners, health care professionals, government leaders and industry professionals around the globe. Through educational initiatives that foster scientific exchange and collaboration among leaders in the field, SITC aims to one day make the word “cure” a reality for cancer patients everywhere. Learn more about SITC, our educational offerings and other resources at sitcancer.org and follow us on Twitter, LinkedIn and YouTube.
About IBCG
The International Bladder Cancer Group (IBCG) is a globally recognized entity that has published numerous peer-reviewed articles addressing knowledge gaps in - and providing recommendations for - the management of bladder cancer.
The IBCG was formed with a primary objective being to address global educational needs and learning gaps in order to improve the care and management of patients with urothelial carcinoma. The inaugural meeting, in 2006, consisted of members selected as representatives of their varied geographic regions across Europe, North America and Asia. The members were specifically selected not only for their expertise but also to ensure representation from across the globe.
Over the years, the mission of the IBCG has been to improve outcomes of patients suffering from bladder cancer through critical evaluation and leveraging of existing data to drive evidence-based treatment. An additional goal is to develop practical educational tools that are applicable to the global urological community and thus enhance the care of patients with bladder cancer on a global level.
You can read more about IBCG at https://www.ibcg.info/.