Wednesday, July 2, 2008

Grassley thinks blinding doesn't matter, at least in ENHANCE

So, I've been meaning to discuss this for some time, and will do so, but I will note that Sen. Grassley thinks blinding doesn't matter on the ENHANCE trial, that simulations could have been run to assess statistical significance on the basis of blinded data.

Of course, this is disturbing on several levels. I'm going to argue that kind of analysis is possible but risky. At the same time, this will make blinding arguments much weaker. As it stands now, anyone who lays eyes on an unsealed randomization schedule, the results of an unblinded analysis, or any summary that might involve unblinded analysis is considered unblinded and therefore should not make decisions that influence further conduct of the study. The worst case scenario of this new argument is that anybody with blinded data and the potential knowledge of how to assess statistical significance based on blinded data will be considered unblinded.

Now, we're getting into murky territory.