To Any Expert with knowledge of Clinical Trial Analysis | IMGN Message Board Posts

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Msg  49875 of 51175  at  9/20/2019 1:59:48 PM  by

erniewerner

The following message was updated on 9/20/2019 2:01:08 PM.

 In response to msg 49874 by  Bibliobiftek
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Re: To Any Expert with knowledge of Clinical Trial Analysis

 ".... but it seems like an OS endpoint will take far too long compared to a PFS endpoint and for a company whose cash runway is measured in months this will matter."
 
The conventional wisdom is that because OS events take longer to occur, OS analyses require a longer trial.  I will point out that in the analyses for the F1 subgroup, the OS analysis had a lower p value than the PFS analysis and I assume they were done concurrently based on a single data lock.  Even though the OS had fewer events, the better hazard ratio .62 vs .69 resulted in a lower p value.  So perhaps the conventional wisdom is skewed in this case because of the differing responses of patients to MS vs chemo treatment.  IMGN will have to look at the underlying data from F1 and decide on which endpoint or combination of endpoints best meets their needs.  Longer follow up of F1 patients to see if that survival comparison keeps improving with time may help.
 


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Msg # Subject Author Recs Date Posted
49876 Re: To Any Expert with knowledge of Clinical Trial Analysis Bibliobiftek 0 9/20/2019 2:09:16 PM






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