Review by Joseph Ross – 04/01/2016 – 2:29pm

Data Request Number: No Data Request Assigned Please use this space to provide any comments, feedback or concerns (optional):

Investigators appear to be requesting data to be used for analyses outside of the secure data sharing platform – they are proposing to merge the 2 bedaquiline trials available via YODA Project with a number of other data sources that examined the use of various other drugs for MDR-TB, comparing outcomes (efficacy and safety) across the various drugs. Whether or not the bedaquiline analyses can be completed within the SAS secure platform, and then the summary information merged into the larger analyses, should be clarified. Or alternatively, whether the other data can be merged within the SAS secure platform.

Recommendation for this data request: Approve