UK patients with various conditions are set to access updated treatments more quickly and safely, now new clinical trial regulations are in force.

The Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) have launched the largest package of clinical trial reforms in more than 20 years.

The new approach will include faster assessment of first-in-human trials and the introduction of notifiable trials. This route allows lower-risk trials to start sooner and modifications to be approved more quickly, while maintaining the highest safety standards.  

The reforms will also strengthen support for early-stage research and embrace early safety data from studies abroad. In addition, they are set to include computer model simulations, which can help to predict how new medicines will behave, before they are tested in patients.  

The news follows the government’s target to reduce clinical trial set-up times to 150 days, outlined in its 10 Year Health Plan for the NHS. Encouragingly for the government, figures already show the MHRA and HRA are reducing set-up times from 169 days to 122 days for studies undergoing combined safety and ethical review. Their combined review process also averages 41 days, less than half the timespan of a few years ago. 

Route B

So far, the Route B substantial modification pathway has been introduced. This was successfully piloted from October last year to March this year to offer faster, risk-proportionate ways to assess certain substantial modifications that don’t introduce new safety concerns.  

During the pilot, applications were typically processed in seven days, and, suggesting the strength of industry support, more than half of registrations came from commercial sponsors. In April, Route B became legally mandated as part of the new regulatory framework. Under it, eligible modifications will be automatically approved unless concerns are raised within 14 calendar days to inform the sponsor that a full assessment is being undertaken. 

The MHRA and HRA gathered the views of patients, researchers, doctors and industry specialists to develop the new framework. They aim to work towards greater transparency, including making it a legal requirement to publish summary results and ultimate patient outcomes.

The industry opinion

“The UK’s new clinical trials regime is a direct response to concerns that the UK has been losing ground as a destination for research, particularly post-Brexit,” said Peter Rudd-Clarke, partner at Osborne Clarke. “By streamlining approvals and reducing friction, the government is trying to make the UK a more appealing location for pharmaceutical companies deciding where to run trials,” he added. 

He went on to ask whether this would be enough. “While the reforms should help, competitiveness depends on more than regulation alone, and the industry will be watching closely to see the impact these reforms, and other related initiatives, have on making the UK a more attractive place to invest,” he said. 

It comes as the Association of the British Pharmaceutical Industry’s recent report, Globally competitive UK-wide data-enabled clinical trials: the time is now, called for better use of NHS health data within clinical trials. In response, the HRA stressed the importance of people feeling confident and able to take part in trials. They shared how their recently established Health Data Research Service is a “huge opportunity” for public trust.