Challenges to the development of new drugs and regimens for tuberculosis.

ABSTRACT

In spite of having effective, safe treatment for tuberculosis, the prevalence, incidence and mortality remain high. One of the ways to improve control of the disease is to reduce treatment duration either with currently used drugs or with the development of new drugs. These will all require clinical testing for safety and efficacy. The increasing complexity of regulations governing the conduct of clinical trials poses a threat to the very indications for which they are intended. There is an urgent need to review and harmonise the guidelines so that they can be administered in a way that does not compromise the safety and well-being of the trial subjects.