We have been working with the Medicines and Healthcare products Regulatory Agency (MHRA) on a set of proposals which we hope will improve and strengthen the UK clinical trials legislation. We believe this will help to make the UK the best place to research and develop safe and innovative medicines.
These proposals are now part of a consultation and we would value your views to help shape the future legislation for clinical trials - you can respond to the consultation until 14 March.
The new legislation is an opportunity to update and improve our regulation to support clinical trials in the best interests of patients, in line with the ambitions of the Life Sciences Vision to make the UK the leading global centre for innovative research design and delivery, across all types and phases of trials.
The legislative proposals outlined in the consultation aim to streamline clinical trials approvals, enable innovation, enhance clinical trials transparency, enable greater risk proportionality, and embed patient and public involvement in clinical trials.
The proposals aim to deliver a proportionate and flexible regulatory regime whilst always protecting patients and trial participants. We have tried to remove barriers to innovation and overly prescriptive requirements in the current legislation. To support this, we want to maximise use of best practice guidance and promote pragmatic interpretation of legislation.
One important part of the proposals is to make public involvement a requirement in legislation. We believe this would send a strong message that trials must be centred on the participants as standard practice to achieve the best outcomes. Currently, our Research Ethics Committees expect researchers to involve patients and the public in the design, management, conduct and dissemination of research.
This consultation is open from 17 January until 14 March 2022.
All responses to this consultation will be carefully reviewed and will feed into the decisions that are made to finalise the proposals and consideration of the drafting of the secondary legislation.