The number of patients is not blinded because the one delivering the drug under investigation (Avid) would have a fairly good idea and also the placebo vendor.
It are the RESULTS that are blinded and the randomizing and arm composition, etc.
For PPHM being on track means that at this moment, JUST entered the 16 month of 24 (8 remaining or 2/3 of the trial window past), they have the number of patients that according their planning to enrol them all for DEC 2015 is the number they should have.
It will ALSO include the fact that the number of patients they planned depended on the opening of the treatment centres and so to be on track with your patient enrolment they needed to be on track with centres opening.
The centre opening is a risk that diminishes in time as centres open. For PPHM that risk was probably gone about 6 months ago. Therefore there last ON TRACK reports are much more reliable then their first ones.
While their on track report of Q1/2014 might be correct at that time, it did carry the risk of deviating from ON TRACK due to not being able to open the treatment centres as planned.
In the ON TRACK of 2 week ago they know the treatment centres where not only opened but opened in time and that they ALSO enrolled the expected number of patients.
So the last ON TRACK carries the risk that between now and DEC 2015, last 1/3 of this trial, the 158 treatment centres would no longer be able to enrol the patients as they did for the first 2/3 of the trial.
However SOME centres might of course have a problem but it is very unlikely that all of them or an important portion of them would suddenly all have a problem.
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