FDA Virtual Public Workshop: Clinical Trial Design for Non-Muscle Invasive Bladder Cancer (NMIBC)

Background

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) and Center for Drug Evaluation and Research (CDER) welcome you to this FDA Virtual Public Workshop: Clinical Trial Design for Non-Muscle Invasive Bladder Cancer (NMIBC).

The purpose of this workshop is to discuss challenges and opportunities in clinical trial design for patients with NMIBC. The ultimate goal of the workshop is to identify actionable next steps towards facilitating feasible trial designs that can capture interpretable and clinically meaningful results.

Sessions 1-3 are on the first day of the workshop (Thursday, November 18th).

• The first two sessions will cover the BCG shortage, impact on clinical practice, and implications for trial design for the BCG-naïve population.
• The third session will focus on trial design in the BCG-unresponsive population and potential trial designs with cystectomy-free survival as a secondary endpoint.

Sessions 4-6 will be on the second day of the workshop (Friday, November 19th).

• Sessions 4 and 5 will cover issues related to trial design for the two distinct classifications of NMIBC; i.e., carcinoma in situ and papillary disease.
• Session 6 will focus on capturing the patients’ perspective in trial design including experiences, needs, and priorities.

Workshop moderators and panelists include regulators, urologists, medical oncologists, and patients. We look forward to productive discussions during this workshop.

Meeting Goals

• Provide a forum for open discussion between academia, international regulators, and patient advocacy groups to advance clinical trial design in NMIBC;
• Develop greater precision around NMIBC disease states to facilitate the rational design of and appropriate patient selection for clinical trials in NMIBC;
• Identify questions that would benefit from further study; and
• Envision novel designs and endpoints for future trials.

Registration

This meeting will be held in virtual format only. Registration is required for online attendance and will be available until noon on November 19th, 2021.

To register for this workshop, visit https://www.eventbrite.com/e/182046996467External Link Disclaimer

Online Attendance

This meeting will be available for online viewing, on the day of the meeting via the following link: https://fda.zoomgov.com/j/1602905396?pwd=YTdjejEzY0hhZUNwenJWak9Jd0M2QT09External Link Disclaimer Passcode: 7Ec#Aj

Workshop Materials

• Agenda
• Biographies:
  • Day 1
  • Day 2
• Background reading
  • Clinical Trial Design for the Development of New Therapies for Nonmuscle-invasive Bladder Cancer: Report of a Food and Drug Administration and American Urological Association Public Workshop (2014)
  • BCG-Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment (Guidance for Industry) (2018)