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1st Qtr Report, page-5

  1. 2,169 Posts.
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    On the negative side it looks like another month or two before the bulk of the centres are back on line, the protocol changes having to be run through their ethics? Committees.
    Positive side we have 50 odd doctors roughly two each from all the activated centres as well as six centres yet to be activated, one would assume very busy people giving up substantive work time to attend trial meeting. Real enthusiasm.
    Back of the envelope estimation.
    We know the trial has no significant safety issues.
    We know from the feasability trial that the first 30 days was clear of HF events. Surrogate for treatment arm in current trial.
    We know that of the 50 patients waiting for implant only 26 made it to through the first 30 days. Generously allowing for 4 "recoveries" plus 10 "unrelated HF deaths" (same as at 6mths for treatment arm of current trial, undoubtably a serious overestimation) leaves us in this surrogate population for the control arm of the current trial, a conservative 20% serious HF related events at 30 days , including many deaths and death equivalents ( ie. Transplant and LVADs ) v zero% serious HF events in surrogate tratment arm.
    How long can this trial continue if your treatment arm is improving and your loosing 20% of your control arm every 30 days to HF events?
 
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