Clinical development of anti-tuberculosis drugs.

In the clinical development of new anti-tuberculosis drugs, the most important step is efficient Phase II studies to show whether the drug is likely to be able to shorten treatment and with what other drugs it has the greatest sterilizing activity. The use of non-linear mixed effects modelling applied to serial sputum cfu counts appears to be the most effective technique, but we know little about the optimal design of such novel studies. A paper in the current journal reports on the relative efficiencies of various timing patterns in sampling sputum.