The assessment of new anti-tuberculosis drugs for a paediatric indication.

For the first time in three decades there is a promising pipeline of more than 20 new anti-tuberculosis agents at various stages of development, and several are already entering early clinical trials. Childhood tuberculosis (TB) comprises a significant part of the TB caseload, particularly in developing communities. There is, nonetheless, as yet no agreed pathway for the assessment of anti-tuberculosis agents in children. The feasibility of assessing an anti-tuberculosis agent in a childhood population is discussed in the present study, and it is concluded that it would be very difficult to assess the efficacy of an anti-tuberculosis agent in children due to the wide spectrum of diseases encountered in children and the lack of objective criteria to assess the response to treatment. However, it is essential that the pharmacokinetics and toxicity of any new agent should be assessed in a population of children over a range of ages.