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01/23/19 9:12 PM

#209702 RE: IkeEsq #209698

An interim analysis for efficacy is where someone who is designated to do so (like the Data Monitoring Committee or some such group) officially looks at the efficacy data in an unblinded manner. It uses some alpha to so do. There was to be an efficacy look at PFS when they reached a certain percent of - I think it was 80% or so - the PFS events.

According to the protocol, they were only to be done with the PFS data set.

Some bears have claimed that an efficacy look was done and that the trial was found to be futile.

Of course, if they'd done one, and futility was the finding (not a possible futility - I mean futility) many would argue that such a finding should have been made public.

Now... I don't personally think a formal one was done. I think there may have been a strong suspicion that there may have been an issue with PFS - one that may have forced the FDA to look at it - but I am speculating here. I don't think the company ever did. Still... I can understand why flipper would like to have that clearly answered.

flipper44

01/23/19 9:27 PM

#209703 RE: IkeEsq #209698

Right, it was Meirluc (not you). However, #28 did get 11 votes (not 10). It was tied for eighth, not tied for ninth. Regardless, hopefully someone will ask it. Interim Analyses are a very important component of clinical trials. I won't go into it further in this post.

In the DC Vax-L Phase III trial, how many efficacy Interim Analyses (IAs) were conducted and what type of information did NWBO receive concerning the efficacy IAs, including but not limited to whether or not the endpoints were statistically significant?


Astavakra 01/23/2019 01:52:49 PM
Here's 10 of the many good Qs provided. antihama 01/22/2019 03:11:51 PM
My votes: Pablosrv 01/22/2019 12:27:56 PM
My votes for Questions.... I am part of the alphapuppy 01/22/2019 10:27:52 AM
I am voting for.... meirluc 01/22/2019 10:10:38 AM
791branko 01/22/2019 09:03:51 AM
My top ten list. Thank you for reg2015 01/22/2019 08:39:15 AM
My votes are as following:- pgsd 01/22/2019 02:48:37 AM
Awesome work on the question list. aperture007 01/21/2019 11:05:38 PM
Here is my vote FWIW. flipper44 01/21/2019 08:23:30 PM
Since today started the official tabulat Doc logic 01/21/2019 06:01:23 PM