Composition of the data monitoring committee, its role and reporting structure {21a}
TB
The DSMB will consist of five members: a clinician with experience in treatment for drug-sensitive and MDR-TB, an epidemiologist, a pharmacologist, a statistician and a TB laboratory science expert. The DSMB will be installed to safeguard the interest of trial participants and include an element of expert advice that is independent of the sponsor and the principal investigators. Further, the DSMB will review data and will make recommendations to the TSC to stop single arms or the whole trial if trial participation is an undue risk to participants.