4 ms·
Retrospective real world data and mining from EHR is useful, but it’s not as robust as a prospective randomized clinical trial. There is no protocol so not all
by refurb 4y ago
Retrospective real world data and mining from EHR is useful, but it’s not as robust as a prospective randomized clinical trial.
There is no protocol so not all data is captured. You’re also relying on the robustness of the data capture which is no where close to as good as a clinical trial because it’s just clinical practice.
As such, you need to filter and refine data sets, which opens up the green jelly bean problem. Filters become subjective based on “best thinking”.
Which is fine, but guess who looks at the holes in the data and decides they won’t pay for it? Public and private healthcare payers.
I’ve been involved in those negotiations. Non-RCT data is “suspect” and it’s not unusual to hear “go back and conduct another trial so you have reliable data”.
They are great complements, but not a substitute for RCTs.
- rocqua 4y agoThis matches what the author says no? He argues that clinical trials (i.e. deciding whether to approve a drug) should always be randomized. At the same time he believes there is lots of potential for real-world-data in other steps. Pre-trial simulation, post approval outcome tracking, automated drug-interaction analysis, etc. The data analysis is incredibly valuable, even if not suited for drug approval decisions.