Document ID: FDA-2009-N-0664-0050
Agency: fda
Document Type: Notice
Title: Issues in the Design of Clinical Trials of Antimycobacterial Drugs for Treatment of Tuberculosis; Public Workshop
Posted Date: 2009-06-09T04:00Z

[Federal Register: June 9, 2009 (Volume 74, Number 109)]
[Notices]
[Page 27335]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jn09-79]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Issues in the Design of Clinical Trials of Antimycobacterial
Drugs for Treatment of Tuberculosis; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop regarding scientific issues in clinical trial design for the
treatment of tuberculosis. This public workshop is intended to bring
together public health experts, health care providers, academia, and
industry to share perspectives on scientific aspects of antimicrobial
drug development for tuberculosis. Topics will include considerations
in the development of clinical trials to study treatments for
tuberculosis, including enrollment of patients, the effect of
antimicrobial treatment, study endpoints, and statistical issues in
analysis of results. The input from this public workshop will help in
developing topics for further public discussion.
    Date and Time: The public workshop will be held on July 30, 2009,
from 8 a.m. to 5:30 p.m. and on July 31, 2009, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Crowne Plaza
Silver Spring, 8777 Georgia Ave., Silver Spring, MD 20910. Seating is
limited and available only on a first-come, first-served basis.
    Contact: Christine Moser or Ramou Mauer, Center for Drug Evaluation
and Research, Food and Drug Administration, Office of Antimicrobial
Products, 10903 New Hampshire Ave., Bldg. 22, rm. 6209, Silver Spring,
MD 20993-0002, 301-796-1300.
    Registration: To register electronically, e-mail registration
information (including name, title, firm name, address, telephone, and
fax number) to TBwkshp@fda.hhs.gov by July 22, 2009. Persons without
access to the Internet can call 301-796-1300 to register. Registration
is free for the public workshop. Interested parties are encouraged to
register early because spaced is limited. Seating will be available on
a first-come, first-served basis. Persons needing a sign language
interpreter or other special accommodations should notify Christine
Moser or Ramou Mauer (see Contact) at least 7 days in advance.

SUPPLEMENTARY INFORMATION: FDA is announcing a public workshop
regarding antimicrobial drug development for tuberculosis. This public
workshop will focus on scientific considerations in designing clinical
trials for tuberculosis. Topics for discussion include the enrollment
of patient populations with tuberculosis, the effect size of
antimicrobial treatment for tuberculosis, assessing effect size of a
new drug in a multi-drug regimen, various endpoints that might be
considered to assess drug efficacy for trials of tuberculosis, the
timing of assessment for efficacy, extrapolation of safety and efficacy
to other subpopulations, and statistical issues in analysis of results
from trials in tuberculosis. The input from this public workshop will
help in developing topics for further discussion.
    The agency encourages individuals, patient advocates, industry,
consumer groups, health care professionals, researchers, and other
interested persons to attend this public workshop.
    Transcripts: Transcripts of the public workshop may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 20 working days after the public workshop, at a cost of
10 cents per page. Transcripts will also be available on the Internet
at http://internet-dev/cder/meeting/tb.htm approximately 45 days after
the workshop.

    Dated: June 2, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-13419 Filed 6-8-09; 8:45 am]

BILLING CODE 4160-01-S