Today we are proud to be celebrating International Clinical Trials Day.
Clinical trials are a vital part of efforts to develop new treatments, devices and methods of care.
The next 12 months will be an important period for clinical trials in the UK.
We’re in the early stages of the implementation period for the UK’s updated clinical trial regulations, which represents the most significant update to the regulations in 20 years.
The changes, delivered in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA), will help create a faster, more efficient, more accessible and more innovative clinical research system – making the UK a world leader in clinical trials.
The new legislation is intended to support more streamlined and flexible regulation of clinical trials, removing unnecessary administrative burdens on trial sponsors, whilst protecting the interests of trial participants.
It puts Combined Review, the way research teams seek approval from a Research Ethics Committee and the MHRA for new Clinical Trials of Investigational Medicinal Products (CTIMPs), into law for the first time.
It will also become a legal requirement to register clinical trials in a public registry and publish a summary of trial results within 12 months of completion.
Some areas - such as diversity, public involvement, and patient engagement - will be supported through detailed guidance rather than new legal requirements.
In the next few weeks, we will be publishing our guidance to explain what will be changing in the updated regulations.
Developing new digital services
Behind the scenes we’ve also been hard at work developing new digital services that will underpin the new regulations.
These new services will improve the end-to-end journey for researchers making applications for clinical trials.
We are making it as easy as possible for users to plan and prepare new research, make changes to existing research and review and approve research applications in a seamless way.
To make sure these new services are the best they can be we are looking for people to help us test them.
If you use IRAS (the Integrated Research Application System), TOPS (The Over-Volunteering Prevention System) or HARP (the HRA Assessment Review Portal) we would love to hear from you.
Be Part of Research
We are also proud to be supporting the National Institute of Health and Care Research’s ‘Be Part of Research’ campaign which has launched today.
Be Part of Research is a free service which makes it easy to find and take part in health and social care research across the UK.
You can search for trials and studies into health conditions you’re interested in, at locations near you.
Whether you have a health condition or not, you can help find new and better ways to treat diseases, and improve care by taking part in research.
It's easy to get involved - simply visit the Be Part of Research website.