Anavex Life Sciences Corp (AVXL)

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What Must Be Blinded?

In a double-blinded clinical trial the only thing that would have to remain undisclosed to trial sponsors during the trial would be who in the trial is in what arm. No one, patients, medical professionals, or trial sponsors should be able to clearly identify who is taking the placebo (in the control arm) or who is taking the actual drug, in any of the experimental arms of the study.

But how might the accuracy of the trial be compromised if actual on-going clinical results from all participants were compiled and made available to both medical professionals and the trial’s sponsor? If (as in the Anavex 2-73 Australian Alzheimer’s trial) the on-going symptomatic results for all 450 patients, 150 in each of the three arms (150 in the placebo, control arm, 150 each in a low and a high dose arm) were aggregated in an arm-un-attributed listing, those analyzing the aggregated data could note the trends.

What if the aggregated data revealed that 310 participants were sleeping soundly? Or, 142 had symptomatic data that remained at baseline, with no discernable improvement; contrary to the other 308, who’s multiple symptom plots revealed positive trends? (Of course, ponder what such a data set might indicate.)

With these data, no patient or physician is able to positively determine who’s taking what; only that about two-thirds are improving as the trial continues; one third remain at symptomatic baseline. The necessary placebo effect remains untainted and in full force.

Are the final results of the trial (when it ends, sometime later) in any way compromised by the provision and analysis of the entire trial’s aggregate data?