Drug trial changes will make UK one of world’s best places for research

Medical advances now mean the prognoses for many of the most serious diseases are significantly improving – the chances of surviving cancer, for example, are now double those of 50 years ago.

These medical advances would not have been possible without clinical trials. As well as speeding up patient access to cutting-edge treatments, we know that trials lead to better care outcomes for participants overall.  They also bring with them significant investment in the economy.

Earlier this year, the Government commissioned an independent review, led by Lord O’Shaughnessy, into the UK commercial clinical trials landscape, to help unlock growth and investment opportunities and tackle some of the key challenges facing the sector.

One of the challenges we have faced is the impact of the pandemic. This resulted initially in a sharp decline in approvals for non-Covid clinical trials, and more recently to increased demand as UK researchers have sought to build on the success of Covid research – leading to a backlog.

Thanks to the concerted efforts of the Government and the UK regulator, we can now announce that the backlog has been eliminated and all regulatory approvals for new trials are being granted within a month.

We know there is still more to do to bring ground-breaking trials to UK patients routinely, which is why the Government has already announced an upfront funding commitment of up to £121 million to help achieve the goals set out in Lord O’Shaughnessy’s review to boost clinical trials and make the UK a more attractive destination for investment.

Important improvements already

A full response to Lord O’Shaughnessy’s recommendations will be published later this year, and there have been important improvements made already.

As part of this, the MHRA has taken advantage of the opportunities of the EU exit and is now undertaking a total overhaul of clinical trials regulation – the biggest in over 20 years – which will see a plethora of changes introduced ranging from slashing red tape to streamlined trial approvals to greater transparency.

The changes will cement UK trials as innovative, inclusive and international, making the UK one of the best places in the world to conduct research for patients and researchers.

The reforms mean moving away from a “one-size-fits-all” regulatory approach to a more flexible and risk-proportionate one. This approach underpins a new streamlined scheme for the lowest-risk clinical trials – these being later-stage trials that meet a set of strict criteria, such as there being no known safety issues with the medicine being studied.

This means we can save valuable time spent by experts unnecessarily reviewing trials where the risk is lowest and get around 20 per cent of trials up and running quicker, giving UK patients faster access to the potentially life-saving medicines.

Patient and public involvement central

The reforms also mean greater transparency. Data-sharing is essential for informed decision-making in clinical practice and for public trust, so the UK has introduced a mandate for companies to publish a summary of results within 12 months of the end of the trial in a publicly accessible register.

Sharing trial findings with participants in a timely manner and suitable format will also be required by law. The reforms mean making patient and public involvement central, because evidence suggests that the results of clinical research are richer if a variety of voices are involved in the design and conduct of trials.

Without doing so, reaching under-served and under-represented populations in clinical research will be difficult, something the Health Research Authority has championed consistently through its excellent work in this area.

Last week, some of the best minds in clinical research from across academia and industry met with the MHRA to discuss the plans. The discussion, which covered everything from how to extend streamlined trial approvals to medium risk trials to building international compatibility, was a refreshing reminder that the UK has some of the best expertise at its fingertips.

This makes sense – our National Health Service, close links with a large academic community and the infrastructure to support innovative research and development, make the UK a life sciences superpower.