Medical advances now mean that the prognosis for many of the most serious diseases is improving significantly: the chances of surviving cancer, for example, are now double what they were 50 years ago.
These medical advances would not have been possible without clinical trials. In addition to accelerating patient access to cutting-edge treatments, we know that trials lead to better care outcomes for participants overall. They also bring with them important investments in the economy.
Earlier this year, the Government commissioned an independent review, led by Lord O’Shaughnessy, of the UK’s commercial clinical trials landscape, to help unlock opportunities for growth and investment and address some of the key challenges facing the UK. sector.
One of the challenges we have faced is the impact of the pandemic. Initially, this resulted in a sharp decline in non-Covid clinical trial approvals and, more recently, a surge in demand as UK researchers sought to build on the success of Covid research, leading to a delay.
Thanks to the concerted efforts of the UK Government and regulator, we can now announce that the backlog has been cleared and that all regulatory approvals for new trials will be granted within one month.
We know there is still much to be done to bring innovative trials to UK patients routinely, which is why the Government has already announced an initial funding commitment of up to £121 million to help achieve the targets set out in the review by Lord O’Shaughnessy. to boost clinical trials and make the UK a more attractive destination for investment.
Major improvements now
A full response to Lord O’Shaughnessy’s recommendations will be published later this year and significant improvements have already been made.
As part of this, the MHRA has seized the opportunities of EU exit and is now undertaking a total review of clinical trials regulation (the largest in over 20 years) which will see a host of changes introduced ranging from from cutting red tape to streamlined trial approvals for 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 involve moving away from a “one size fits all” regulatory approach towards one that is more flexible and proportional to risk. This approach underpins a new, simplified scheme for lower-risk clinical trials: later-stage trials that meet a set of strict criteria, such as no known safety problems with the drug being studied.
This means we can save valuable time experts spend unnecessarily reviewing trials where the risk is lowest and get around 20 per cent of trials up and running faster, giving UK patients faster access to potentially life-saving medications.
Patient and Public Engagement Center
The reforms also mean greater transparency. Data sharing is essential for informed decision-making in clinical practice and for public confidence, which is why the UK has introduced a mandate for companies to publish a summary of results within 12 months of end of the trial in a publicly accessible record.
The law will also require sharing trial results with participants in a timely manner and in an appropriate format. The reforms involve making patient and public participation central, because evidence suggests that the results of clinical research are richer if a variety of voices participate in the design and conduct of trials.
Without doing so, it will be difficult to reach underserved and underrepresented populations in clinical research, something the Health Research Authority has consistently championed 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 extending approvals from simplified trials to medium-risk trials to creating international compatibility, was a refreshing reminder that the UK has some of the best experiences within its reach.
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.
