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Regulation of clinical trials: Brexit and beyond

Following Brexit, the UK and EU have to decide whether, and how, to continue cooperating on clinical trials. Our report finds that the best option for trials is full UK participation in the EU clinical trials system. 

What’s inside 

  • different options for the regulation of clinical trials in the UK after Brexit 

Who this is for

  • UK and EU policy makers 
  • research funding organisations
  • anyone interested in clinical trials

Key findings

  • The best option for UK and EU clinical trials after Brexit is full UK participation in the EU clinical trials system. This would be on a similar basis to Member States. The UK and EU should seek to agree this in future negotiations.
  • There are alternative options, but they involve significant trade-offs that would have an impact on both UK and EU clinical trials.
  • If full participation can’t be negotiated, the UK should meet its commitment to put the EU Clinical Trial Regulation into law and should remain highly aligned to the EU framework in the short-term to minimise disruption.
  • In the longer-term, the government and regulators should engage widely on the options and trade-offs to agree the best alternative for the wide range of clinical trials taking place in the UK.
“Over 4,800 UK–EU clinical trials took place between 2004 and 2016. Around 40 per cent of the trials currently running in the UK are being run with other Member States.”

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