Research Article: Ensuring the Involvement of Children in the Evaluation of New Tuberculosis Treatment Regimens

Date Published: August 19, 2008

Publisher: Public Library of Science

Author(s): William J Burman, Mark F Cotton, Diana M Gibb, A. Sarah Walker, Andrew A Vernon, Peter R Donald

Abstract: William Burman and colleagues review the barriers to involving children in studies of new tuberculosis treatments and recommend strategies for overcoming these barriers.

Partial Text: Global tuberculosis control is threatened by dramatic increases in HIV-related tuberculosis and by the emergence of multidrug-resistant strains. Highly lethal outbreaks of extensively drug-resistant tuberculosis among HIV-infected persons in South Africa [1] demonstrate the public health emergency that results when these two forces converge in the same setting. Fortunately, at this time of great need, tuberculosis drug development has been roused from its decades-long slumber. New ways of using existing drugs and the development of new drug classes hold great promise for the treatment of both drug-susceptible [2–6] and drug-resistant tuberculosis [4–8].

Although not well articulated in the published medical literature, a number of barriers to the involvement of children have been raised in discussions of tuberculosis drug development (Box 1). Our concern is that these barriers may, once again, lead the field down the path of least resistance—the exclusion of children from tuberculosis drug development efforts.

The first and perhaps the most important step toward involving children in tuberculosis drug development is to clearly articulate the necessity of doing so. To shine a light on the path of least resistance is to show how clearly unacceptable it is; children have the same right to benefit from research as do adults. Researchers, regulatory agencies, advocates, and government agencies and private foundations that fund drug development must insist that the development pathways for all new agents/regimens include specific plans for when and how children will be involved.

We are on the threshold of revolutionary improvements in the treatment of tuberculosis. Within five to ten years, it is likely that highly effective three-month regimens will be available to treat both active and latent drug-susceptible tuberculosis. New drug classes that have the potential to dramatically improve the treatment of multidrug-resistant tuberculosis are entering clinical trials. Children have the same right as adults to benefit from research with these new treatments. By making a deliberate choice to avoid the path of least resistance, we can ensure that both adults and children benefit from these advances in tuberculosis treatment.



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