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In this section, we aim to respond to one of the questions we're asked the most – how has our work improved things for other people?
The laws which regulate the way clinical trials of medicines are carried out in the UK are changing.
Clinical trials aim to find out more about an illness, condition, treatment, therapy, or care by directly including people in a project. This sort of research may ask people to take part by testing a new treatment, using a device or by being cared for in a certain way. It may also ask them to provide information about the care they usually have.
In the UK, clinical trials of medicines are approved and regulated by the HRA and the Medicines and Healthcare products Regulatory Agency (MHRA). The laws setting out what must happen are the Medicines for Human Use (Clinical Trials) Regulations 2004.
The updated regulations will be debated by parliament early in 2025 and after a 12 month implementation period will come into force in early 2026.
To support the new laws, we have been developing new guidance for organisations carrying out health and social care research. To do this, we've been working with the MHRA, researchers, research sponsors, members of Research Ethics Committees and members of the public.
What will the updated regulations and guidance mean for people involved in research?
High-quality clinical trials can speed up diagnosis, improve treatment, and enable the NHS to provide world-class care. The updated regulations will support more streamlined and flexible regulation, whilst protecting the interests of trial participants.
For the first time, there will be a legal requirement to offer to register clinical trials in a World Health Organization (WHO) recognised public register, publish a summary of results within 12 months of the end of the trial and offer to share trial findings with participants using plain language that is easy to understand.
Alongside the regulation, we’re producing guidance to ensure clinical trials represent a diverse population, and involve members of the public in the design, conduct and dissemination of research.
How have the views and experiences of members of the public informed and shaped this work?
The process of updating the clinical trials regulations started in 2022 with a public consultation about how regulation could be improved and strengthened. Over 2,000 responses were received.
Working with the MHRA, we've used this feedback to update the regulations to create a faster, more efficient, more accessible and more innovative clinical research system – making the UK a world leader in clinical trials.
We set up new working groups to develop guidance clarifying expectations for diversity and inclusion and public involvement in clinical trials, and continued to work with our Make it Public group to embed transparency at all stages of the research process.
Dave Chuter, Patient Advocate:
Our involvement in developing the guidance helps build public and patient trust in research by showing that our experience and expertise has been listened to as part of the process. The new supporting guidance will ensure that research is transparent to all.
There is more detail about all the changes on our website.
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