A Companion to Understanding Regulatory Data - Part 1

Redefining the “E” in EBM

This is the first of two posts intended to ease the conceptual transition from biomedical journals and mainstream information to regulatory evidence. 

The article was originally published in 2018 as Jefferson T, Jørgensen LRedefining the ‘E’ in EBM. BMJ Evidence-Based Medicine 2018;23:46-47.

It was published when Carl was Editor-in-Chief and should provide a recap as to 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 your time reading and parsing 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.

The philosopher of science, Thomas Kuhn (1), would probably have called our reliance on biomedical journal trial evidence a paradigm. It has served us well, allowing the building of the philosophical (2) and practical (3) backbone of evidence-based health care. However, like all paradigms, soon…