New transparency requirements for clinical trials in the UK
On April 28, new legal transparency requirements for clinical trials came into force in the United Kingdom.
There are three main changes:
- The trial must be made public in a dedicated registry before enrolling the first patient, or within 90 days of approval.
- Results must be published within 12 months of the trial’s conclusion.
- A lay summary must be provided to participants within the same period.
One aspect not to be underestimated: registration on the EU CTIS alone does not satisfy the new UK requirements. Registration in a separate registry compliant with UK regulations is required.
Non-compliance will result in formal sanctions and possible legal action by the competent authorities. Non-compliance may also jeopardize the approval of future trials.
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