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  4. FDA Workshop: Clinical Trial Design for Non-Muscle Invasive Bladder Cancer (NMIBC) - 11/18/2021
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Virtual | Virtual

Event Title
FDA Workshop: Clinical Trial Design for Non-Muscle Invasive Bladder Cancer (NMIBC)
November 18 - 19, 2021

Date:
November 18 - 19, 2021
Day1:
Thu, Nov 18
Day2:
Fri, Nov 19

Organized By:
Oncology Center of Excellence and the Center for Drug Evaluation and Research/Office of Oncologic Diseases

Twitter: # FDANMIBC21

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.

Workshop Materials

Event Point of Contact

Joan Ferlo Todd, RN, MS
Senior Regulatory Health Project Manager
Oncology Center of Excellence, (OCE)
Office of the Commissioner (OC) U.S. Food and Drug Administration
10903 New Hampshire Ave, Silver Spring, MD 20993
Tel: 301.796.6079
Joan.Todd@fda.hhs.gov

Caitlin Drew, MSN, RN
Senior Regulatory Health Project Manager
Oncology Center of Excellence, (OCE)
Office of the Commissioner (OC)
U.S. Food and Drug Administration
10903 New Hampshire Ave, Silver Spring, MD 20993
Tel: 301.318.8609
Caitlin.Drew@fda.hhs.gov

Event Materials

Title File Type/Size
Jarow NMIBC Urology 2014 pdf (109.19 KB)
FDA NMIBC Workshop Nov 18-19 Agenda Final Version pdf (142.39 KB)
Day 2 NMIBC Biographies 11-19-21 pdf (553.62 KB)
Day 1 NMIBC Biographies 11-18-21 pdf (550.42 KB)
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