A Companion to Understanding Regulatory Data - Part 2

Refining the “E” in EBM

This is the second of two posts intended to ease the conceptual transition from biomedical journals and mainstream information to regulatory evidence. The article was originally published as Jefferson T. Refining the E in EBM. BMJ Evidence-Based Medicine 2020;25:189-190.

It was published when Carl was editor-in-chief, and we should provide a recap of the rationale for preferring regulatory data in our reviews, especially for important and complex issues like the effects of Comirnaty and other global vaccines.

Please take the time to read and parse its content, and as usual,  let us know if anything is unclear. This post can also be read as a companion to our antivirals series.

We address the need to change our evidence sources for assessing the effects of pharmaceuticals and biologics because of the danger of unrecognised reporting bias. In this note, I shall discuss the possibility of using a shorter way of redefining the “E” compared to using clinical study reports. 

In the first note- …