Answer
What does FDA expect from real-world evidence?
FDA expects real-world evidence to be planned like a trial, and the bar rises with the role the evidence plays. In the recorded episode this product reads, the panel puts it in three themes: prospective planning, with the protocol and statistical analysis plan shared before the study; fitness for use, meaning data that is relevant and reliable, accurate, complete and traceable to a source that ca
FDA expects real-world evidence to be planned like a trial, and the bar rises with the role the evidence plays. In the recorded episode this product reads, the panel puts it in three themes: prospective planning, with the protocol and statistical analysis plan shared before the study; fitness for use, meaning data that is relevant and reliable, accurate, complete and traceable to a source that can be verified; and robustness, with sensitivity and subgroup analyses pre-specified so the result does not hinge on one assumption.
Where the evidence is offered as the main comparison, the expectation is higher than where it is used for context. An external control arm is where the bar is highest, and the episode is explicit that the eligibility criteria, endpoint definitions, confounding and contemporaneous care all have to be addressed.
Where this comes from
The checks behind this answer are on the rule set, each with the timestamp in the recorded source. The legal basis is on the basis page. Run the free check on your own outline.