Re: Third Eye and Topline
in response to
by
posted on
Dec 20, 2018 01:15PM
At the 2017 AGM Don said it was taking 90 to 120 days to get events adjudicated. They were working with the group doing the adjudication to get that down to 60 days or less. This lead me to believe that events are adjudicated as they occur, with a lag period. On Sept 12 we were told that there had be 200 events which would only leave 50 left to go. Even though we are getting less events occurring than projections, it should be just a relatively small number of events that need to be adjudicated in the final strokes of the trial. At this years AGM Don did say that they could speed up the time for adjudication if they paid for it. This all leads me to the conclusion that adjudication could take somewhat less time than what is being suggested.
Follow ups. Here's where there could be a lag, if not a significant lag from original design. If the design had not changed there would be dribs and drabs of patients completing dosing each week or month. This would allow the clinics to do follow ups as patients completed their 104 weeks of dosing at that specific time. That data would flow into the data collection company and compiled as it came in. Now all patients remain on dosing until the 250th event occurs and all follow ups now need to occur at the same time. Where there had been plenty of space to get follow ups done there is now the possibility of log jams. All patients 70 and over need to have their final cognitive test. All CKD patients need to have their eGFR testing. Blood work at the end of the trial and then again a few weeks later. My major hope is that the company operating the trial is exceptionally well organized as this is very different from original design.
I don't think this will materially affect the top line results but may lengthen the full trial results by a few weeks or more.
All in all IMO it is a good thing that events are not occurring at the predicted rates. It would be best if that is as a direct result of patients on 208 are having few if any events at all.
All IMO, dyodd.
tada