Framework amending the UK clinical trial regulations laid before Parliament

Some of the key amendments that will be introduced include: 

• Proportional regulation of lower risk clinical trials (deemed ‘notifiable trials’), including low risk trials that (together with other requirements) have been approved by a licensing authority in the European Union, an EEA state or the USA.   Notifiable trials will not require approval from the MHRA; only a notification to the MHRA. Approval from a Research Ethics Committee will still be required.  Other flexibilities will apply to lower risk clinical trials, including simplified means for seeking and recording consent and a risk-adapted approach for labelling. 
• The combined review process for approval will be introduced into law, and entrench the single application route currently used in practice for obtaining both MHRA and Research and Ethics Committee approval.  
• New transparency requirements will apply and require registration of clinical trials in the World Health Organisation (WHO) recognised public register, and publication of trial results on this public register within 12 months of the end of the trial.  It will be possible to apply for deferral of the publication requirements for a period of up to 30 months to protect commercially confidential information.  
• Archiving periods for trial master files will be extended from 5 years to 25 years. 
• The introduction of a sunset period on approvals - clinical trial approvals will lapse after a proposed sunset period of two years if no participants have been enrolled within the sunset period. 
• The introduction of requirements for ‘non-investigational medicinal products’ including that these be manufactured in accordance with good manufacturing practice and meet certain labelling requirements. 

The proposed statutory instrument is closely aligned with the amendments proposed by the MHRA in its public consultation on the UK CTR in 2022. Although the UK has adopted a more flexible approach to low risk clinical trials than the EU, the amendments will bring the UK CTR into closer alignment with the EU clinical trial regulations. 

The MHRA and HRA will be preparing comprehensive guidance to accompany the new legislation on issues that have been identified as better supported through guidance, including good practice in clinical trials, inclusion and diversity and involvement of members of the public in the design, conduct and dissemination of research. 

Authored by Jane Summerfield, Bonella Ramsay and Alexandra Wood.