Trial design for testing immunotherapy in tuberculosis

In view of the increasingly widely accepted need for immunotherapy as the only real hope for the improvement of treatment under realistic field conditions, the failure of the Durban trial to yield interpretable data raises important questions about future exploitation of immunotherapy, whether immunological or endocrinological. Is it possible to devise a trial in patients with drug-resistant disease that would conform to regulatory requirements? The sporadic distribution of these patients and their lack of uniformity has frustrated attempts to devise such trials in the past. Secondly, and more importantly, would it be possible to design a study that could be performed under realistic field conditions that would satisfy regulatory bodies? Until these dilemmas are resolved, it may not be possible to test immunotherapy for tuberculosis in a meaningful way.

We are grateful to the Wellcome Trust and the Neuroendocrinology Charitable Trust for supporting the investigation of the endocrinology of human tuberculosis. R.H.-P. is grateful to the CONACyT (Consejo Nacional Ciencia y Tecnologia) for supporting laboratory work in Mexico (grant O235P-M95Û6), and to both the Royal Society and the European Community (INCO-DC contract no. ERBIC18CT960060) for supporting visits to the UK.

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