E9-13419. 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.

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 [e-mail] 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.