Dendreon Corp fka DNDNQ

[croumagnon]

"Ordinarily, a trial protocol does not allow the DSMB to reveal the statistics of an interim analysis to the sponsor other than to say whether the analysis met the threshold for halting the study."

One more silly game for these grown men to play! What you are saying is true but I still have not heard one good reason to date why it is so. How can knowledge interfere with anything?? Perhaps, as the rest of your post suggests, knowledge in this case may make the sponsor change the remainder of the trial by reacting to the interim analysis. Even then, I still do not see how that is a problem? If by changing they forfeit their SPA agreement, then that is their problem. On the other hand, perhaps after seeing the interim results, the company may decide to stop the trial, even then so what?

I have heard the argument that such is not allowed for fear that the company may demand approval at some interim point because a fluke in the statistics at some interim look may always be a lucky strike and show good results which will not be confirmed in the full trial. Sort of the "many shots at goal argument" but, this time, unlike the meaningless Flemmings argument against survival, such an argument would have merit. In response to that I say so what?? The company can claim whatever it wants and the FDA does not have to comply...