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

Streszczenie

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, 1