Not even a day after I suggested, in the comment-threads, below, that CEO Clark would have to update his IMPROVE-IT projections pretty soon, he obliged, and just did so.
New Merck has apparently adopted the legacy Schering-Plough practice of putting material updating disclosures in "Investor FAQs" documents, but not (always) including them in official Merck press-releases. I think this is a silly -- and risky -- practice to undertake. But I'll save more detailed remarks on that topic for another day.
I think the reality is that the study will not be complete until 2014 or later. I also noticed (courtesy of a friend of the blog), that Leerink Swann has put out a note indicating that CEO Clark has apparently said IMPROVE-IT will not be halted for "futility".
In plainer English, what that means is that even if there is no statistically-significant difference between the two arms in the study (at either the 50% event marker, or the later 75% event marker), Merck will let it continue. In short, Merck will spend money on a futile study. In fact, I think it likely that the study is already showing futility. Allowing it to continue to completion -- in 2014 or beyond -- delays the inevitable (or so Whitehouse Station seems to believe), right?
Recall that we saw a less-polished version of this same approach -- in ENHANCE. I think a null result in IMPROVE-IT is a better than 50-50 probability, given the outcomes of ENHANCE, SEAS and ARBITER 6-HALTS.
Mark my words: I predict Whitehouse Station will move IMPROVE-IT's official projected completion date back once again, in early 2011, when the study fails to reach the 50% marker by the end of 2010 -- and that projected date will be mid-2014, or later. In any event, here is the new projection:
. . . .Merck submitted an update to clinicaltrials.gov to include a date of June 2013 as the new forecasted date for the completion of the IMPROVE-IT study. The revision is based on updated estimates reviewed by the IMPROVE-IT Executive Committee and Merck. The estimate for this event-driven trial reflects the most recent information on the pace of enrollment and the accumulation of clinical endpoints to date, and takes into account the minimum two and one-half years of follow-up called for in the study design. . . .
What is clear -- even now -- is that it may be almost a year, after study completion, before the final results are published -- so 2014 may come and go without published results.