Drug-resistant tuberculosis (DR-TB) is a growing public health problem, and for the first time in decades, new drugs for the treatment of this disease have been developed. These new drugs have prompted strengthened efforts in DR-TB clinical trials research, and there are now multiple ongoing and planned DR-TB clinical trials. To facilitate comparability and maximise policy impact, a common set of core research definitions is needed, and this paper presents a core set of efficacy and safety definitions as well as other important considerations in DR-TB clinical trials work. To elaborate these definitions, a search of clinical trials registries, published manuscripts and conference proceedings was undertaken to identify groups conducting trials of new regimens for the treatment of DR-TB. Individuals from these groups developed the core set of definitions presented here. Further work is needed to validate and assess the utility of these definitions but they represent an important first step to ensure there is comparability in clinical trials on multidrug-resistant TB.
Furin, J.; Alirol, E.; Allen, E.; Fielding, K.; Merle, C.; Abubakar, I.; Andersen, J.; Davies, G.; Dheda, K.; Diacon, A.; Dooley, K.E.; Dravnice, G.; Eisenach, K.; Everitt, D.; Ferstenberg, D.; Goolam-Mahomed, A.; Grobusch, M.P.; Gupta, R.; Harausz, E.; Harrington, M.; Horsburgh, C.R.; Lienhardt, C.; McNeeley, D.; Mitnick, C.D.; Nachman, S.; Nahid, P.; Nunn, A.J.; Phillips, P.; Rodriguez, C.; Shah, S.; Wells, C.; Thomas-Nyang’wa, B.; du Cros, P. Drug-resistant tuberculosis clinical trials: proposed core research definitions in adults. International Journal of Tuberculosis and Lung Disease (2016) 20 (3) 290-294. [DOI: 10.5588/ijtld.15.0490]