USA – FDA gives draft adjuvant trial guidance for RCC, bladder cancer

Two new draft guidances from the US Food and Drug Administration give investigators a roadmap for clinical trials of adjuvant drug or biologic therapy for two common cancers. The first of the guidances released on 1 October addresses adjuvant treatment for bladder cancer, and the other addresses adjuvant treatment of renal cell carcinoma (RCC).

“Currently, there is significant variability in the design, conduct, and analysis of clinical trials” that examine adjuvant treatment for renal cell carcinoma and bladder cancer, said Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence in a press statement announcing the new draft guidances. “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 development of therapies,” said Pazdur…