Issues in the Design of Clinical Trials of Antimycobacterial Drugs for Treating Tuberculosis
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The US Food & Drug Administration (FDA) is hosting a public workshop on July 30-31 2009, to review scientific issues in clinical trial design for treating tuberculosis. The 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, officials note.
The FDA encourages individuals, patient advocates, industry, consumer groups, health care professionals, researchers, and other interested persons to attend this public workshop. There is no charge to attend.
Topics will include considerations in developing clinical trials to study treatments for tuberculosis, including enrollment of patients, effect of antimicrobial treatment, study endpoints, and statistical issues in analysis of results.
In particular: 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, timing of assessment for efficacy, and extrapolation of safety and efficacy to other subpopulations. The input that is received will help in developing topics for further public discussion.
When and Where:
July 30-31 2009
Crowne Plaza Silver Spring
8777 Georgia Ave
Silver Spring MD 20910
Contact Info:
Christine Moser or Ramou Mauer
Office of Antimicrobial Products
FDA Center for Drug Evaluation & Research
10903 New Hampshire Ave Bldg 22 Rm 6209
Silver Spring MD 20993-0002
Phone 301-796-1300.
The FDA encourages individuals, patient advocates, industry, consumer groups, health care professionals, researchers, and other interested persons to attend this public workshop. There is no charge to attend.
Topics will include considerations in developing clinical trials to study treatments for tuberculosis, including enrollment of patients, effect of antimicrobial treatment, study endpoints, and statistical issues in analysis of results.
In particular: 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, timing of assessment for efficacy, and extrapolation of safety and efficacy to other subpopulations. The input that is received will help in developing topics for further public discussion.
When and Where:
July 30-31 2009
Crowne Plaza Silver Spring
8777 Georgia Ave
Silver Spring MD 20910
Contact Info:
Christine Moser or Ramou Mauer
Office of Antimicrobial Products
FDA Center for Drug Evaluation & Research
10903 New Hampshire Ave Bldg 22 Rm 6209
Silver Spring MD 20993-0002
Phone 301-796-1300.
