Modified all-oral shorter MDR-TB regimens (i.e. regimens that differ from the recommended 9-month shorter regimens) should only be implemented under “operational research conditions”. The main conditions are:
- a study protocol, which must include a 12-month follow-up after the end of treatment;
- a clinical treatment guide that includes a patient consent process;
- an approval by the national ethics review board or ministry of health; and
- at a minimum, an “aDSM core package”9(18).
The ShORRT research package provides more guidance on the development of the protocol, data collection tools and other supporting documents that facilitate operational research for modified alloral shorter MDR-TB regimens (61).
9 See Web Annex 3.