What you’re choosing to ignore is that the trial continuing after an statistical analysis would mean the said trial hasn’t officially ended. Meanwhile they told us they would do the statistical analysis at the END of the trial. This at face value means the trial is DONE. You can’t have a continuing trial if it ends. And so I take their words to mean END of the trial.
There words are clear. Yours includes your own context.
“The Company has been blinded at all times, with no access to any data in the Phase III trial, and WILL REMAIN FULLY BLINDED UNTIL THE TRIAL IS COMPLETED. The changes relate to the statistical analyses that WILL BE DONE AT THE END OF THE TRIAL, and do not affect the treatment protocol, dosing, randomization of patients or other such aspects.” August 2014 PR
They also made it clear in February 2017 that ALL treatment data needed to be in before analyzing the data.
“The external parties managing the Trial are now moving forward with the process to reach data lock. In this process, ALL data from ALL of the treatment visits and follow up visits for all 331 patients in the Trial, must be subjected to quality control checking. The process involves in-person monitoring visits to all of the 80-plus sites in four countries to review the files onsite, as well as other documentary confirmation and checking of all MRI images. As such, it is a multi-month process. While this process is under way, OS and PFS events will continue to accumulate.” — Feb 2017 PR
You read this below, you must read above to get the meaning of Quality Control Checking is, and it is ALL not some treatments. ALL
“The Trial will reach data lock when the threshold events have been reached AND the QUALITY CONTROL CHECKING has been completed for both the PFS and OS endpoints. When data lock is reached, external statisticians and experts will make an independent analysis of the Trial data. The Company will remain blinded until data lock has been reached and the external data analysis has been completed.” - Feb 2017 PR
How can they complete quality control checking before ALL treatments. According to your context you can. According to their words, “ALL data from ALL of the treatment visits and follow up visits for all 331 patients in the Trial, must be subjected to quality control checking.” So ALL 331 patients consents must be complete the 36 month treatment and crossover schedule.
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