Frrol and Bio:
It could be that I am confused and/or do not understand the discussions about biomarkers. If so, please let me know.
My understanding is that a predictive biomarker is usually measured before treatment and provides information on the probability of response to a particular therapy. Therefore, for example, if predictive biomarkers are identified in patients in both groups, the placebo group and in the drug group, and the patients identified with predictive biomarkers respond favorably in the group that receive the drug with some of the patients identified in the placebo group having a mixed response, some with a placebo response and some with no response, may that be of any use in addressing the placebo issue.
I ask that question because not everyone, including those with identified biomarkers, that receive the placebo will necessarily have an effect, correct? Some patients with identified predictive biomarkers in the placebo group may have no response during the 14 week trial period. However, those very same patients may receive the drug in the OLE after 14 weeks, and they may have a response. I am assuming that patients with predictive biomarkers will respond favorably if AVXL 2-73 has efficacy. Therefore, it would be relevant to know how patients with predictive biomarkers faired during the 14 week trial and afterwards in the OLE, right?
It may also be that the placebo response, if any, may be greater or less in placebo patients than the response by those receiving the drug. That information, may be relevant as well.
Am I making any sense? Perhaps I am not because I really do not understand biomarkers and their use in clinical trials. Or, perhaps any analysis along the lines I have described is of no use in disproving or proving anything when it comes to the placebo effect.
