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Tuesday, December 15, 2015 6:41:17 PM
Very nice effort on your projections. It looks like you're onto something. I think I can help with the 1st interim look issue. Per investor relations, it will be based on the "number of events in patients enrolled in trial at the time". This means that it will be at 33% of 582 or 192 events. I've posted about this subject several times in the past. Refer to post #226882. The fact is, there's no set rule on what the interim looks need to be based on. The sponsor decides what they want and includes it in the protocol that gets approved by the FDA.
Also, regarding enrollment projections. Here's a nice study that might interest you titled "Monte Carlo Simulations for Patient Recruitment".
http://www.cytel.com/hubfs/Patient_Enrollment_White_Paper_Final.pdf
Regards,
mojo
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