Glen Clack, Lecturer in Faculty of Health and Life Sciences Departmen at University of Exeter Medical School, shared a post on LinkedIn:
“The sharpest description of a badly run clinical trial was written in 1939. It said nothing about clinical trials.
In a statistics journal of that year, Professor Rathburn of Stanford defined a lecture as ‘a process whereby the professor’s notes become the student’s notes without passing through the minds of either’.
I have sat through enough quality meetings to confirm that the risk assessment which becomes the SOP which becomes the monitoring plan, all without disturbing the mind of a single soul en route, is the very same phenomenon, merely wearing a lab coat.
This is the precise mischief that Quality by Design was invented to cure. Shorn of its consultancy wrapping, the idea is almost embarrassingly plain: decide in advance which errors actually matter, engineer against those, and decline to police the remainder with the grave diligence of a man straightening the antimacassars as the house burns down. Quality is built in; it is not inspected in after the fact.
For years one could treat the whole thing as an ecumenical matter and carry on ticking boxes. No longer. ICH E6(R3), the first serious rewrite of Good Clinical Practice in a generation, has rather set the cat among the pigeons: proportionality is now a stated principle, risk-based thinking the expectation rather than the exception, and the guideline is in force across the EU, UK, US and Switzerland, with Annex 2 for decentralised and real-world-data trials arriving in 2027. The box-tickers are, not to put it too strongly, out of road.
I have written the business up as a referenced teaching note: the provenance, the mechanics, the E6(R3) update, a worked early-phase example, and a set of discussion questions for the intrepid. Minds, on this occasion, are required to be involved.”
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