UK Government position on clinical trial transparency

The UK government issued a policy paper on 22 February to improve clinical trials transparency in response to 10 recommendations a House of Commons Science and Technology committee report issued in October 2018.

Importantly, in relation to lay summaries of clinical trials, the response to recommendation 1 states:

‘In the event of a negotiated agreement with the EU that allows the UK full access to the new EU portal, the UK will fully align with the transparency requirements of the Regulation.

If UK trial information and results are not part of European registers in the future, the Government will make sure this information could be published on a national basis’

Based on this response, it appears that lay summaries of clinical trial results will be mandated for trials with a site in the UK, if the UK has full access with and alignment to the EU portal. The situation remains less clear if the UK is not allowed full access to the EU portal, given the use of the word ‘could’ in the response.