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Thursday, January 14, 2016 8:56:26 PM
The one thing that keeps getting missed by such simplified analysis is the mechanics of the trial. Things that we do not know about. I think there are too many unknowns to apply such simple analysis and make declarations about efficacy.
An example of such an instance is time from event, to when the event is reported. Obviously events are not reported the instance they occur. I would expect there is a delay. How long, we do not know. Is it days, weeks, even months? How often are these patients making office visits? What is the mechanism by which events are reported? Is there a consistency among all the sites in this regard? Is there a consistency among countries?
This is a huge unknown. We have no idea how this works, and also how quickly sites are reporting events. There could be a long lag time. And inconsistencies among sites. And it may take time and analysis to even determine if an event has happened. This all takes time!
This is just one example of the things that need to be taken into account. The mechanics of the trial and how things are reported. We do not have enough information to make statements about efficacy. Just my opinion.
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