Making it easier to do clinical trials that everyone can trust

Last updated on 21 Mar 2023

The HRA welcomes today’s response to a consultation on clinical trials regulations by the Medicines and Healthcare products Regulatory Agency (MHRA).

Today’s response is a clear and exciting opportunity to ensure that clinical trials can speed up diagnosis, enhance treatment and enable the NHS to deliver world-class care, as well as cementing the UK’s position as a life-science superpower.

The response, which will be used to inform new legislation and guidance, follows a public consultation by our organisations in partnership. The majority of those who took part in the consultation agreed that change is needed to make it easier to do clinical trials that everyone can trust. There was strong support for increasing transparency about clinical trials, the importance of meaningful public involvement in clinical trials and increasing diversity among those taking part these trials while ensuring that the UK is the easiest place in the world to do research that people can trust.

It sets out a proportionate and agile approach to signal the UK’s high expectations for how clinical trials should be conducted, using a mix of legislation and guidance so that everyone understands what is expected, how to do it and can easily show us what they have done.

The HRA makes it easier to do health and social care research with and for everyone. We will work with patients and the public, researchers, commercial and non-commercial research funders to inform legislative change and develop guidance that is proportionate, flexible and reflects the scale and nature of different clinical trials, helping you to do more high quality clinical trials.

We are focused on doing this through a range of support to:

  • make research more transparent
  • increase public involvement and diversity in research
  • help make research happen faster
Developing a flexible and proportionate approach to clinical trials

One of the key principles behind the new legislation is streamlining the regulation of trials, to make it easier to do high quality research that people can trust. This includes removing duplication, and ensuring research is more proportionate to risk. The legislation also enables more innovative, people-centred trials such as decentralised trials.

One of the best ways to make sure trials are efficient and successful is to get input from relevant members of the public. Unfortunately, some research studies are still designed without meaningful public involvement.

Our analysis shows that more than half of clinical trials say they have not involved the public.

On 10 March, we celebrated the one year anniversary of the launch of our Shared Commitment to public involvement in health and social care research and are now working with all the partners, including NHS England, to embed excellent public involvement across the sector.

Public involvement in clinical trials is always possible. We’re delighted that the respondents to the consultation agreed. How people are involved will look different for different types of trials. We will make sure, through policy and guidance, that everyone understands what is expected, knows how to do it and can easily tell us about it.

We’re also working with MHRA to help researchers increase the diversity of people taking part in research in the UK.

Today we also launch new content to help researchers increase the diversity of people taking part in research so that it can benefit everyone.

Making transparency easy

Transparency about research that’s going on, and what its findings are, is important for patients, service users and the public. It builds trust and accountability, acknowledges their contribution and encourages participation in research.

We’ve already made it easier to register studies using automatic registration for clinical trials approved through our combined review process on the ISRCTN registry. It will now be a legal requirement to register trials in a World Health Organisation (WHO) public register. There will also be a requirement to publish a summary of results within 12 months of the end of the trial. Sharing trial findings with participants in a timely manner and suitable format will also be required by law.

Help us to write effective guidance that drives change

We’re looking for people to support our work with the MHRA to develop new guidance for researchers on how to better involve the public and ensure diverse participation in clinical trials and continue to improve transparency practice.

This opportunity is open to researchers, research participants and anyone involved in making research happen, including members of Research Ethics Committees. To hear first about opportunities to get involved, please register your interest.

What happens now?

Today’s announcement helps take forward the ambition we set with the launch of our strategy last year, to ensure that research findings improve care faster because the UK is the easiest place in the world to do research that people can trust. We’re excited to help lead the change to come.

You can sign up receive HRA Latest to keep up to date with our work on the reforms to clinical trials legislation.

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