FDA-NCI Public Workshop: Defining Disease Recurrence and Harmonizing Conduct in Adjuvant Bladder and Kidney Cancer Trials

Organized by the:
U.S. Food & Drug Administration (FDA) and National Cancer Institute (NCI)
with support from the Society of Urologic Oncology (SUO)
Twitter #OCEGU17

Co-Chairs: Sundeep Agrawal, MD, FDA/CDER
                  Harpreet Singh, MD, FDA/CDER and
                  Andrea Apolo, MD, NIH/NCI

Date: November 28, 2017

Time: 8:00 a.m. to 5:00 p.m.

Location:  National Institutes of Health
                  Natcher Conference Center (Building 45)
                  Room E1/E2
                  9000 Rockville Pike
                  Bethesda, MD 20892


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:

  • Discuss inclusion and eligibility criteria for adjuvant bladder and kidney cancer trials
  • Discuss considerations in defining and managing disease recurrence on adjuvant bladder and kidney cancer trials
  • Review common goals and methods for clinical trial conduct

Who Should Attend:

This public workshop is intended for a diverse group of stakeholders, including leading academic experts, regulatory agencies, pharmaceutical industry representatives, scientists and clinicians from regulatory, academic, and other healthcare sectors, patient advocacy representatives, and other experts in biostatistics and correlative science.

Webcast Information:

FDA provided a free-of-charge, live webcast of the November 28, 2017, FDA-NCI public workshop. A recording of the webcast can be found at the following address: https://fda.webex.com/fda/ldr.php?RCID=b0cb8f306a9d89e5d0f7454a25c09776disclaimer icon

Meeting Materials

Slide Presentations

Considerations for Harmonizing Clinical Trial Conduct in Adjuvant Bladder and Kidney Cancer Trials: Inclusion Criteria and Disease Recurrence
Sundeep Agrawal, MD - FDA

Harmonizing Inclusion Criteria Across Adjuvant Bladder Cancer Trials: Disease Characteristics and Surgical Considerations

Defining Radiographic Eligibility and Disease Recurrence on Adjuvant Bladder Cancer Trials: Strategies and Challenges

Management of Non-Muscle Invasive Disease on Adjuvant Bladder Cancer Trials

Harmonizing Inclusion Criteria Across Adjuvant RCC trials: Disease Characteristics, Surgical Considerations, and Exploration of Biomarker Driven Trials

Defining Radiographic Eligibility and Disease Recurrence on Adjuvant Renal Cell Cancer Trials: Strategies and Challenges


Frank Cross, Jr., M.A., MT (ASCP)
Senior Regulatory Health Project Manager
Division of Oncology Products 1
Office of Hematology and Oncology Products
Center for Drug Evaluation and Research
Food and Drug Administration
Phone: (301)796-0876
E-mail: frank.crossjr@fda.hhs.gov

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