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Related Experiment Video

Updated: Jun 21, 2025

An Orthotopic Bladder Cancer Model for Gene Delivery Studies

An Orthotopic Bladder Cancer Model for Gene Delivery Studies

Published on: December 1, 2013

Advancing Clinical Trial Design for Non-Muscle Invasive Bladder Cancer.

Elaine Chang¹, Noah M Hahn², Seth P Lerner³

¹Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.

Bladder Cancer (Amsterdam, Netherlands)

|July 12, 2024

Summary

This summary is machine-generated.

Developing new treatments for non-muscle invasive bladder cancer (NMIBC) is a priority. A workshop highlighted the need for better clinical trial designs to accelerate the approval of effective NMIBC therapies.

Keywords:

BCG BCG-unresponsive anti-neoplastic agents clinical trial design regulatory

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Last Updated: Jun 21, 2025

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Published on: September 13, 2018

Area of Science:

Oncology
Urology
Drug Development

Background:

Non-muscle invasive bladder cancer (NMIBC) has limited FDA-approved therapies, creating an unmet clinical need.
Bacillus Calmette-Guerin (BCG) supply shortages emphasize the urgency for alternative NMIBC treatments.

Purpose of the Study:

To discuss research needs and clinical trial designs for NMIBC therapies.
To foster collaboration among stakeholders for advancing NMIBC drug development.

Main Methods:

A public virtual workshop convened by the FDA on November 18-19, 2021.
Multidisciplinary participation including urologists, oncologists, pathologists, statisticians, scientists, and patient advocates.
Included invited lectures, panel discussions, and audience engagement.

Main Results:

A survey revealed 92% of urologists prioritize developing BCG alternatives for high-risk, BCG-naïve patients.
Key discussions focused on disease state definitions and trial designs for various NMIBC subtypes.
Considerations included single-arm trial limitations, patient-reported outcomes, and cystectomy avoidance as an efficacy endpoint.

Conclusions:

The workshop identified critical areas for refining NMIBC clinical trial designs.
The FDA encourages early discussion of trial proposals with regulatory divisions to expedite NMIBC drug development.