It has been a month since the data committee last met and almost a month since the data was available for analysis. I am hoping that they meet this week and we get some updates on events. Is it better to be an optimist and face disappointment or a pessimist and be pleasantly surprised?
You also have to factor in how much more fun it is to be an optimist and have the result you were expecting, than be a pessimist and just be relieved to hear the good news.
I fit into the latter catergory, uncategorically!
If Scott had to lose, I'm glad it was to Ernie!
OK - some messages are indicating that the safety people and the analytical people might be the same group and that they meet on Tuesdays? Well - correct me if I'm out of line here - but this data is supposed to be available - any time - according to Brad at the General Meeting. And at one point I am pretty sure he said it was a matter of people plugging numbers into a spreadsheet. I don't get why it is taking so long. This isn't the more detailed look which is supposed to tell us home many more we need in the trial.
I suppose that some of the treatment centers could have been delayed getting them info?
But - don't you think that that people compiling this data are fully aware of the significance of the info and that they wouldn't wait for a weekly(monthly? ) meeting to announce the results? I would think Brad is asking them daily for a status.
I would find it strange if some of these trial sites did not keep good and up to date records on these 80 patients. These records should have been up to date like any patient record would be.
I also find it odd that taking a key and unblinding 80 patients would take more then 1 day to do.
At this rate plugging in the numbers is taking as long as our average enrollment of patients , Super slow pace. Could they be unblinding 1 before lunch and 1 after lunch? Or are we waiting on the DSMB to meet again next quarter.
here is a website that talks about unblinding statistical significance and reaching p values "0.05" . from this paper it sounds like the DSMB does both . If they meet every 3 months we have a way to go.
we presented a statistical decision rule for data safety monitoring purposes when the primary efficacy and primary safety endpoint of a clinical trial is mortality. This rule was designed for ease of interpretation by DSMB members with little or no formal statistical training. The goal of this method is to provide a means of controlling the approximate Type I error control for the efficacy analysis, while monitoring safety in a continuous fashion. As was discussed above, the method may be modified to accommodate more complex designs. Future work will involve studying the probability theory behind the utilization of different sequential bounds for efficacy and safety such this information can be incorporated into the sample size parameters during the design phase of the trial.
>>My understanding is that all 80 patients will be viewed as dead at their second scan. Only at the end of the trial will all data be incorporated into the study. But for this peek they are considered dead.<<
I think you meant all PFS will be considered to have progressed as of the day after the data date of record. And I believe both our go/ no go and the estimate of patients need to complete will be based on the data now being analysed.
I am not sure if patients are assumed to have PD 1 day after the 12 week scan or one day after their latest available scan (assuming they are PF at that point). However I recall the analysis also uses weighting when taking into account the significance of each patient in calculating the % COS for the go/no go decision. This suggests that they do take later scans into account when available, otherwise why/how could you use weighting?
>>I am not sure if patients are assumed to have PD 1 day after the 12 week scan or one day after their latest available scan (assuming they are PF at that point)..<<
You're right of course. I should have said all PFS patients are considered progressive after the 80th patient's second scan. Or whatever day they look at that body of information.
"If you are suggesting the the collection of the data is haphazard you make my point ... BT is inept and should be fired by the BoD! Of course this wont happen since BT is also the COB and has his band of "nerry clowns" at his disposal.
If we had a competent CEO we would have a share price in the 30's. "
Guys, I honestly don't know why you bother to answer crap statements like this!!! All he/she is doing to rile you up and respond.
I think they answer 'crap' statements like this because there's a grain of truth in them. I know for some, ie armed, BT is his Joe Paterno...forever enshrined with statue proudly displayed between his fanatic eyes, but for others BT is a bumbling idiot whose most effective skill in the final anaylsis is squeezing an undeservedly high rate of pay for a third rate player such as he is. No shame in that. Greed still counts as a virtue for many and in this Brad shines between the missed conferences and sub par efforts to get the Reo story out.