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Msg  26452 of 42518  at  2/17/2016 11:47:56 PM  by


 In response to msg 26446 by  leave_the_gun
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Re: P3 clinical trial sites

I guess it's all water under the bridge anyway.  I'm more interested in what happens from here forward.  But when history has proven Eric to be wrong about so many things in the past, it's difficult to place much faith in his projections about things such as a mid-year interim assessment for the P3.
Having said that, it was quite interesting to re-read this segment from the 2015-03 CC (Eric):
"The study does have an interim assessment, as I mentioned during my introductory comments, when half of the required events have occurred, that’s basically close to half of the patients have had disease progression, because it’s a 2 to 1 randomization, we have language in the protocol that will allow us to close the study early if the number of advanced don't occur in the projected number, that number then is based on the null hypothesis which is patients in both arms of the study will have progression at the same rate. Obviously the goal of any clinical trial is disprove the null hypothesis and so as the sponsor, we expect that there will be a difference in the rate of progression, number of progression of that in the two study arms. And that's the basis for that additional opportunity to terminate the study if those events don’t occur. So the fundamental design of the study, again 18 months since last summer, 30 month overall we will do our best to exceed that accrual rates. We can't force the patients to have disease progression but we've done everything we can to make sure that in the event that there is disparity in disease progression between the two study arms that we are allowed to end the study at an appropriate time. Again most importantly perhaps to the investment community and to prospective partners is that we do have an interim assessment which allows us to examine and report interim data when the study is halfway through."
Some of the above wording suggests that there are indeed additional mechanisms for triggering an interim assessment, beyond the "half of the required events" criterion.  Which supports what Dom has been writing.  But regardless of what may trigger an interim assessment, the trial would obviously need to have some minimum number of participants before there is any really possibility of stopping it early.      

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Msg # Subject Author Recs Date Posted
26453 Re: P3 clinical trial sites leave_the_gun 0 2/17/2016 11:54:46 PM

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