I attended a workshop at the NIH Campus in Bethesda, MD with a number of kidney cancer oncologists, surgeons, FDA representatives, National Cancer Institute staff (NCI), Society of Urologic Oncology (SUO), and several industry and patient advocates. The following is some background information:
The FDA, NCI, and SUO have agreed to joint development of a public workshop that may improve the conduct of adjuvant clinical trials in bladder cancer and kidney cancer by harmonizing definitions and management of disease recurrence. Currently, no standard definition of disease recurrence is used in these adjuvant trials. Standard practices would generate consistency and facilitate interpretation of trial results. This joint venture will enable the oncology community to combine its resources and knowledge to optimize clinical trial utility and efficiency to better serve our patients.
Goals and Objectives:
- To standardize definitions of disease recurrence for use in bladder and kidney cancer adjuvant trials
- To develop methods for managing disease recurrence in patients on adjuvant bladder and kidney cancer adjuvant trials
- To discuss clinical trial and research designs with the goal of generating consistency among clinical trials in the adjuvant bladder and kidney cancer setting
- To define common goals and methods for these adjuvant trials in the form of a potential guidance document
For more detailed information you can go here: https://www.fda.gov/Drugs/NewsEvents/ucm574531.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery