TY - JOUR T1 - The World Health Organization global aDSM database: generating evidence on the safety of new treatment regimens for drug-resistant tuberculosis JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.01643-2017 VL - 51 IS - 3 SP - 1701643 AU - Christine M. Halleux AU - Dennis Falzon AU - Corinne Merle AU - Ernesto Jaramillo AU - Fuad Mirzayev AU - Piero Olliaro AU - Karin Weyer Y1 - 2018/03/01 UR - http://erj.ersjournals.com/content/51/3/1701643.abstract N2 - Marketing new medicines before pre-registration clinical trials are complete may sound rash and risky. But when treatment options are scarce in the face of a lethal, transmissible disease the balance tilts in favour of “use” rather than “wait”. Such were the conditions under which bedaquiline and delamanid (two new tuberculosis (TB) agents) were introduced a few years ago. This article relates how uncertainties about the safety of these new drugs were handled to enable their use.The World Health Organization has created a central database to improve knowledge on drug-related harms of patients on novel tuberculosis regimens http://ow.ly/lfVm30ihRcOThe authors wish to thank Michel Vaillant (Luxembourg Institute of Health) for technical support in setting up the global aDSM database, as well as the external experts who participated in the development of the framework (see [15], annex 1). ER -