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Ensuring the Involvement of Children in the Evaluation of New Tuberculosis Treatment Regimens

23 Sep 2008

Paul Chinnock

Source: PLoS Medicine (see original article)

Citation: Burman WJ, Cotton MF, Gibb DM, Walker AS, Vernon AA, et al. (2008) Ensuring the Involvement of Children in the Evaluation of New Tuberculosis Treatment Regimens. PLoS Med 5(8): e176

2008 This is an open-access article distributed under the terms of the Creative Commons Public Domain declaration, which stipulates that, once placed in the public domain, this work may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose.

The last few years have seen a remarkable increase in tuberculosis research but almost none of the trials of new treatments have included children. William Burman and colleagues point out that: ‘Children are a critical part of the global tuberculosis pandemic, with an estimated 900,000 cases and 100,000 deaths per year. In high-burden settings, children make up as much as 20% of incident cases of active tuberculosis.’

In an article in PLoS Medicine, the authors say that, nearly 40 years after the development of short-course TB treatment, there are still fundamental uncertainties about age-appropriate dosing for children. They call for children to be included in trials of new TB treatments, while recognising that this does pose many difficulties. The barriers to be overcome include:

Difficulty of confirming active tuberculosis among children
Concerns about paediatric-specific side effects
Uncertainties about the appropriate time to involve children in drug development and the optimal trial designs for doing so
Regulatory requirements regarding the inclusion of children
Concerns about further subdividing the limited resources available for drug development.

Burman et al. discuss each obstacle in turn and offer solutions. They point out that, in clinical trials of treatments for other diseases, the inclusion of children has become much more common. In the opinion of these authors, children will stand to benefit fully from progress made against TB only when there are child participants in research.