How can you now mitigate these differences in terms of bias?

Yeah.

That's a great question.

I think the short answer is it depends on what data you have and how well you understand the comparison between what is measured in a trial and what's available in these, whether it's clinical notes or what's available in the comparator arm.

So to that point, I think the best way to mitigate those differences is to have some validation study conducted or some data available where you can, for each patient, directly compare these two different methods of the outcome, where you can say, "Okay, on, on this visit there was imaging done, and per certain criteria it was determined that the patient was responding to treatment." And then you also have some version on that same day for that same patient that says what sort of is documented in that EHR system.

A- and you can then compare how often do they draw the same conclusion, how often do they not.

And then you can use those metrics of sensitivity or specificity in this validation study and use those metrics to adjust your analyses in future studies.

In terms of that, do you have any experience in terms of documenting these things and pre-specification in term achieving transparency?