The laws which regulate the way clinical trials are carried out in the UK are changing.
We've been working with the Medicines and Healthcare products Regulatory Agency (MHRA) for the past two years to draft proposals to update clinical trials regulations.
Today we reached a milestone in that process. The statutory instrument to amend the Medicines for Human Use (Clinical Trials) Regulations 2004 has been laid before Parliament.
The updated regulations will be debated in the new year and after a 12 month implementation period will come into force in early 2026.
Updating this crucial law started in 2022 with a public consultation which asked for feedback on how the regulation of clinical trials could be improved and strengthened in the UK.
We’ve been working with the MHRA to use that feedback to update the current regulations to create a faster, more efficient, more accessible and more innovative clinical research system – making the UK a world leader in clinical trials.
Changes in the updated regulations
The new legislation laid today 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.
The inclusion of Combined Review reinforces our joint commitment with the MHRA for the regulatory assessments of clinical trial applications to be completed within statutory timeframes. The timeline for Research Ethics Committees to review CTIMPS is 60 days. 100% of applications met this target for the past 12 months.
Underpinning the new regulations is a clear standard for how clinical trials should be conducted in the UK.
Clinical trials are founded on trust, and the new regulations clearly set out what researchers should do to give people the confidence to choose to take part in a clinical trial.
Some of the key updates to the regulations that the Health Research Authority has been leading on are improving the transparency of research, the constitution of Research Ethics Committees and a simplified means of seeking and recording consent for some trials.
Transparency
Under the new regulations, for the first time it will be a legal requirement to register clinical trials in a World Health Organization (WHO) recognised public register, and to publish a summary of results within 12 months of the end of the trial.
Offering to share trial findings with participants in a timely way, and in language which they can understand will also be required by law.
Dr Catriona Manville, Director of Research Policy at the Association of Medical Research Charities (AMRC)"The new clinical trial regulations will help to embed transparency at all stages of the research process – from trial registrations right through to reporting to participants. Making research and its results publicly available is fundamental to building trust and encouraging participation.
"As a member of the Make it Public campaign group, we’ve been calling for change alongside others from across the sector. The next step is ensuring there is clear guidance to accompany the legislation and deliver on the ambition."
Simplified means of seeking and recording consent
The updated regulations also include the ability to use simplified means of seeking and recording consent in 'lower risk' trials. These are trials involving medicines that have already been approved and therefore pose minimal risk to participants.
Our informal consultation asking for feedback on how this new simplified means of seeking and recording consent will work in practice is still open.
Professor Kerry Woolfall, Professor in Health Research Methodology at the University of Liverpool"I welcome the UK’s new Clinical Trials legislation which sets out the regulatory framework for how clinical trials will be approved, conducted and reported. One of the proposed changes to the law is to simplify the way that informed consent is sought and recorded in ‘low risk’ clinical trials. These trials involve medicines already used in usual clinical practice.
“For many years, patients and the public involved in clinical trials have emphasised the importance of streamlining trial recruitment and consent processes so that potential participants are not burdened by lengthy and inaccessible information sheets. The changes for ‘low risk’ trials will still require an informed consent process yet state information provision should be more proportionate.
“These proposals are a step towards procedures commensurate with the balance of risk and benefit to assist the successful conduct of future clinical trials in the UK."
Research Ethics Committees
The 2004 regulations contained specific requirements for the make-up of Research Ethics Committees and how these groups function.
We received feedback that these requirements have been restrictive.
The new regulations have removed the specific requirements and replaced them with a new provision on how an ethics committee should be constituted, aligning with international good clinical practice standards ICH-GCP E6.
This will give RECs greater flexibility to meet demand and respond to particular situations while still meeting international standards.
Guidance to accompany the new regulations
The government identified a number of areas of good practice in clinical trials that may be better supported through guidance rather than legislative change.
This accompanying guidance is designed to make it clear what the expectations are for research carried out in the UK.
We’re leading on producing guidance to ensure clinical trials represent a diverse population, and involve members of the public in the design, conduct and dissemination of research.
These are all things that people told us were important to them in the public consultation back in 2022.
Inclusion and diversity
In our Public Perceptions of Research survey carried out in 2023, nearly all adults (88%) believe it's important for health and social care research studies to include a diverse mix of participants, even if it means that it costs more (70%) or takes longer (74%).
As part of our inclusion and diversity guidance we've developed a draft set of questions for researchers to consider when they design clinical trials and clinical investigations.
The answers to these questions will form the basis of an Inclusion and Diversity Plan. The questions and supporting guidance have been created in collaboration with members of the public and the research community.
Dr Janet Valentine, Executive Director of Innovation and Research Policy at the Association of the British Pharmaceutical Industry (ABPI)"Passing this much-anticipated legislation is an essential step toward providing the certainty commercial trial sponsors need to invest in and plan more clinical trials in the UK.
"The addition of diversity and inclusion guidance will help to broaden patients’ opportunities to participate in trials of the latest treatments and will bring the UK in line with clinical trials diversity and inclusion expectations already in place in other parts of the world."
Professor Shaun Treweek, Professor of Health Services Research at the University of Aberdeen"The UK’s Clinical Trials legislation being put before Parliament is an important step in making the UK a go-to destination for trialists. I’m especially pleased about the guidance on diversity and inclusion, which will directly support more informative trials by increasing the relevance of results to all those who could benefit, and not just some."
Public involvement
We’re also working on new guidance for public involvement, which is expected and possible for all clinical trials.
Dave Chuter, a patient advocate who has also been involved in the development of the new guidance"As a patient advocate with the lived experience of cancer, the Patient and Public Involvement guidance to accompany the new Clinical Trial regulations is so important for all research for many reasons including; to ensure research is inclusive for all and remove barriers for patients to participate, to ensure that the expertise of experience is in partnership with the researchers from the development of the research question, the delivery of the trial and with the dissemination to the wider public and patients.
“This is a huge step to enable true public and patient involvement in all research - involvement that is meaningful and beneficial to everyone. It will ensure a partnership of researcher expertise with lived experience expertise is seen at all stages and levels within a clinical trial.
“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."
Making the UK a world leader in clinical trials
High-quality clinical trials can speed up diagnosis, improve treatment, and enable the NHS to provide world-class care. But that’s not all. Research published last week by the Association of the British Pharmaceutical Industry (ABPI) showed trials contribute over £7 billion a year to the UK economy, and support more than 65,000 jobs.
Today the government has also announced £100 million of public-private investment to support the set-up of 20 new clinical research hubs across UK. The new centres will give more people the chance to benefit from the latest innovative treatments, and you can read more in our news story.
Today’s milestones are one step closer to the vibrant clinical trials landscape that we all want to see, that patients and the public in the UK deserve – and that everyone benefits from.
It’s a chance to reflect on the change which could make sure even more people can benefit from the promise of research, to celebrate the involvement of those who have given their time so far, and to reaffirm our commitment to work together through the implementation period to get ready for 2026 together.
Keith Berelowitz, Chair of the Fulham Research Ethics Committee (REC)“The new regulations and supporting guidance offer a brighter future for clinical research in the UK. By prioritising patient safety and accessibility, we can ensure that the benefits of research reach everyone.
“The commitment to transparency, diversity, public involvement and simplified arrangements for seeking consent is very welcome. This framework will empower researchers and RECs, giving us the tools to better serve patients and advance new therapies for the good of all.”