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FDA in Brief: Draft Guidance for Uniform Approach to Clinical Trials in Bladder Cancer

By: Susan Reckling
Posted: Friday, October 30, 2020

The U.S. Food and Drug Administration (FDA) recently issued a draft guidance to help facilitate the development of adjuvant treatment of bladder cancer through a more uniform approach to the conduct of clinical trials. If finalized, this draft guidance will provide recommendations to sponsors seeking to develop drugs and biologics for adjuvant treatment of bladder cancer. At the same time, the FDA also issued a similar draft guidance for the treatment of kidney cancer.

“Currently, there is significant variability in the design, conduct, and analysis of clinical trials for [the] adjuvant (additional) treatment of both kidney cancer and bladder cancer. This variability negatively affects our ability to interpret trial results. Researchers need a consistent approach to eligibility criteria and imaging disease assessments to improve trials designed to facilitate [the] development of therapies,” stated Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence and Acting Director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “These draft guidances, if finalized, will assist researchers with recommendations on trial eligibility criteria, standardized imaging assessments, and determining disease recurrence that will improve interpretation of trial results for patients enrolled in clinical trials for these two cancer types.”



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