Ouch! No it's not conjecture. It's a very clear line of logic.
A double-blind trial requires that neither clinicians nor patients know whether the treatment they are administering or getting is the active treatment or the sham (placebo).
Now that the preliminary results have been released and has created the expectation that the treatment produces a strong improvement two things are now true:
a) Every parent, carer and clinician who sees a marked improvement knows almost for certain that they are on the active arm.
b) Every parent, carer and clinician who sees no improvement knows almost for certain that they are on the inactive arm.
The blinding is gone. Simple as that... no conspiracy required. Without the blinding every measurement and observation taken will be influenced by knowledge of what treatment is being administered.
NTI Price at posting:
21.5¢ Sentiment: Hold Disclosure: Held
