Biotech Values

[DewDiligence]

>Now assume that you find that a certain psychological profile predicts a significant proportion (2/3) of placebo response so you regress this out. Thus you are left with 10 responses in the placebo arm and 20 in the treated. The treatment effect is unmasked<

If the stat analysts find this psychological profile associated with a strong placebo response post hoc, then it’s experimental data mining.

If, on the other hand, the trial designers know about this psychological profile a priori, then the sensible thing to do is to exclude patients who have the profile.

In either of the above cases, I have a problem with characterizing the undertaking as “noise cleanup.”