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U.S. Department of Health and Human Services

Drugs

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FDA Public Workshop: Clinical Trial Design Issues - Development of New Therapies for Non-Muscle Invasive Bladder Cancer

Co-sponsored by the:
U.S. Food & Drug Administration (FDA) & American Urological Association (AUA) 
Co-Chairs: Jonathan Jarow, MD and Seth P. Lerner, MD, FACS

This workshop will provide a forum for discussion of clinical trial design, specifically patient selection criteria and efficacy endpoints, for the development of products for the management of non-muscle invasive bladder cancer (NMIBC) that would support U.S. regulatory approval. The workshop will be held in conjunction with the 2013 Annual Meeting of the AUA to be held in San Diego, California.

Date:            May 6, 2013 (Monday)

Time:            1:00 p.m. to 5:00 p.m.

Location:     Manchester Grand Hyatt Hotel
                      Douglas Pavilion C & D
                      One Market Place
                      San Diego, California
                      Phone: (619) 232-1234

General Information

  • Registration: There will be no registration for this workshop.
  • Hotel: Link to Manchester Grand Hyatt disclaimer icon  website.
  • Webcast: A free webcast of this workshop will NOT be available for public viewing.
  • Transcript: A transcript will be available and posted here following the workshop.

Background Information

The workshop will focus on trial design issues related to the development of new therapies for NMIBC including patient selection, comparators, and study endpoints. The meeting is intended to provide beneficial information to both healthcare professionals and the general public. The panelists for the workshop include representatives from urology, medical oncology, biostatistics, patient advocacy, and industry.

The workshop will benefit the FDA in the following ways: (1) foster collaboration and receive input from experts within the scientific and clinical community and (2) obtain input from various stakeholders regarding the development of both clinically meaningful and practical efficacy endpoints to be used in new drug, device and biologics approval.

The workshop will benefit the AUA, cancer care providers, and patients, in the following ways: (1) foster clinical cancer research; (2) facilitate a discussion of strategies to accelerate anticancer drug and device development; and (3) provide transparency via a public forum regarding the regulatory challenges of developing treatments for patients with non-muscle invasive bladder cancer.

For Further Information, Contact

Dianne Spillman
Oncology Program
Office of Hematology & Oncology Products (OHOP)
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration
Phone: 301-796-1467
E-mail: dianne.spillman@fda.hhs.gov