EU issues draft guidelines on providing clinical trial results so you and I can understand them #clinicaltrials

You probably don’t need to hear another thing about the EU, do you?

(By the way what a terrible EU referendum campaign it is – have you ever heard such hyperb******s from our politicians?)

But this really is a good thing.

Following the passage of the new EU Clinical Trials Regulation, the European Commission has started to issue consultation papers on the implementation of its different parts.

One of these concerns the provision of clinical trial results in a format that is understandable by the lay person.  It was issued on 1st June and is out for consultation for three months.   The actual document can be found here. And the page that details the consulation process is here (you will need to scroll down as there are three different consultations).

An important aside is that the guidelines were developed by an expert group led by the UK’s Health Research Authority (HRA) and chaired by the former Chair of INVOLVE, Sir Nick Partridge. So, quite a feather in the cap for the UK.

Interestingly, the HRA points out to me that it was not possible to refer to reading age in the document because only the UK and the USA use this concept and it is not commonly used across the rest of Europe.

You learn something new everyday but only if you are working with others.



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