Bear

Do you think that as biomarker changes leave a signature of the presence of particular drugs in clinical trials that the FDA will need to redefine what “ Blinded” really means ? Gross changes in ALP and eGFR would be patently obvious to a patient as well as their Doctor for instance. I am not thinking / saying that this would be in any way  be predictive of Efficacy , merely that as proxy biomarkers become more defined and more encompassing that they will evolve into an accurate signature of presence of drug ? Ongoing SomaScans from baseline  during a trial would pretty much nail it ? Again not efficacy but certainly presence of drug ? If so how will “Blinded” evolve with the regulators ?