Methodological considerations in clinical trials for new MDR-TB treatment regimens

Abstract

(108 words)In stark contrast to the treatment of drug-sensitive TB, the evidence base underpinning global guidelines for the treatment of MDR-TB is very poor. This, with the lack of experience from previous trials and the nature of the disease, means that there are a number of methodological aspects that are particular to trials of new regimens for MDR-TB. These aspects include the weight of evidence required to change policy and practice, the flexibility to make adaptations to an ongoing trial, the choice of patient population, the importance of the internal control, the duration and frequency of follow-up, and particular safety monitoring for novel combinations of new and repurposed drugs.