Sunday, June 22, 2008 2:03:53 PM
One thing to remember, in big pharma trials the investors are typically kept outside the loop until results are out.
I would wager that an interim checklist/analysis is very common by DSMBs and the size of the trial makes it very susceptable to the need for more patients.
There is never a plan for a study to be halted due to safety findings, as there is never a plan prior to trial initiation to add more patients after interim analysis.
Just one of those things where every trial has data check points which if x happens then standard algorithms are initiated and appropriate actions are taken.
If a trial flows smoothly, that does not mean that check points, or DSMBs did not undergo intermittent analysis of the data. It is not prudent for Cortex or for the DSMB to give releases on each check point though it would be nice for anyone with ADHD or for those who have taken to enjoy the complex flavors of a nice rum or local beer over the last 2 years.
If adding subjects was to replace dropouts, what groups would be most likely to have dropouts. If there was great efficacy in only one group, would there be a need to replace dropouts? Is that different than great efficacy in multiple groups?
Does anyone have the slides of the study plan readily available?
For the number of patients in the study, what is the likely number of patients receiving placebo first and of those what may be a reasonable dropout rate of those,,, if a drop out rate of 25% for those receiving placebo was present then it would seem plausible for the need to add subjects.
Hopefully there was not a significant dropout from those receiving the drug, but due to the time of year and the patient types there probably is an inherently higher dropout rate.
If there was a placebo dropout rate of 25%, just 2 additional dropouts in any 2 of the dose groups may necessitate the need to add subjects
If the trial results are not optimal, possibly due to differences in the causes of RD, then there always is the pipeline and SGP which warrents more than 70cents
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