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Proposed overhaul of clinical research delivery in the UK

During Covid-19, UK clinical research was very much at the front and centre of the global effort to find a vaccine. As we started to emerge from the pandemic, the UK government was keen to implement new measures to help clinical research in the UK maintain momentum.

Back in June 2021, we considered the first phase of the government’s UK wide vision for clinical research. You can read our earlier article here.

So what’s happened since then? Well, in June 2022, the government published the second phase of its implementation plan setting out the steps it will take between 2022 and 2025 to achieve its vision for the future of clinical research delivery. The headlines include:

  • The development of NHS frameworks to cement the importance of research as a core duty. In England, this will include the implementation of the Health & Care Act.
  • The Health Research Authority will lead a cross-sector project to collect evidence about how high-quality, people-centred clinical research is done well. It will make recommendations to help improve the way clinical research happens in the UK.

Last month, the MHRA (the UK’s regulator for medicines and healthcare products) issued a press release setting out its intention to streamline clinical trial approvals in what it describes as the “biggest overhaul of trial regulation in 20 years”.

The new measures, which will be taken forward in new legislation, include:

  • The integration of the regulatory and ethics reviews of clinical trial applications, which in the pilot phase halved the approval times for studies and cut the time from application to recruiting a first patient by 40 days
  • The implementation of a timeline for completion of an application review within a maximum of 30 days in general
  • A legal obligation to share trial findings with participants in a timely manner and suitable format

The new measures proposed by the UK government and the regulator are indicative of an ongoing drive to streamline clinical research delivery in UK. While it remains to be seen what the changes will look like in practice (watch this space), the proposals appear largely positive for life sciences companies conducting clinical research in the UK.


life sciences