FDA Guidance Offers Efficacy Endpoints for TB Clinical Trials

Sponsors designing clinical trials for drugs or multi-drug regimens for treatment of tuberculosis should focus on one of three endpoints: no growth of M. tuberculosis on sputum cultures during treatment; an endpoint comprised of survival and evaluation of M. tuberculosis on serial sputum culture examinations during treatment and 12 months following treatment; and improvement or resolution of symptoms when therapy is completed.
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