Why is the point of randomisation when the treatment ampoules are confirmed to be intact?
The shipment worldwide of glass ampoules in which the trial drug is contained can be problematic because of breakage despite the best packaging. Using the approach where randomisation occurs when the treatment ampoules are confirmed as being intact avoids the investigator having to open all treatment packs in advance to confirm whether an ampoule is broken or not. Opening all treatment packs can cause problems as there is potentially a risk that the treatments can get mixed up. It is unlikely that breakages will routinely happen at any one site. In the event of multiple breakages at any one site, this will be investigated fully to ensure that the randomisation process is not being compromised. A randomisation approach with a fixed block size is being used as the sample size is relatively large. This approach is expected to achieve a balance between groups in size and other characteristics. In addition, a fixed block size will allow for better balance within trial sites.
