The UK clinical trial regulation reforms should help make the region more attractive for clinical development, but proper adoption will be vital, experts say.
On 28 April, the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority’s (HRA’s) reforms to clinical trials came into effect, the first major change in 20 years.
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These developments, which were passed in parliament, include faster assessment of first-in-human trials and the introduction of notifiable trials, a fast-track route to allow lower-risk trials to start sooner, and modifications to be approved more quickly, while maintaining the highest safety standards.
The reforms will make it simpler to start lower-risk studies, strengthen support for early-stage research and embrace new approaches, including the use of early safety data from overseas studies that meet UK standards and computer model simulations, which can help to predict how new medicines may behave before they are tested in patients.
While these reforms will make the UK a more attractive place to run clinical trials, experts question whether the regulation on its own is significant enough.
Industry will watch closely
Peter Rudd-Clarke, partner at law firm Osborne Clarke, said: “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. By streamlining approvals and reducing friction, the Government is trying to make the UK a more appealing location for pharma companies deciding where to run trials.
“The key question is whether that’s 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.”
On top of the new framework, the clinical trial community will be seeking to see clear, concise and pragmatic guidance to help companies prepare for the upcoming changes, said Gerard Hanratty, partner and head of health and life sciences at Browne Jacobson. This will be vital for the industry in order to effectively implement the intended reform.
Hanratty said: “The launch of these clinical trial reforms will be welcomed with open arms by the life sciences industry. For too long, companies have had to navigate a slow and cumbersome process that has acted as a brake on investment and innovation in the UK.
“By streamlining the approvals process, standardising contracting and removing duplicative requirements, there is real hope this can drive new inward investment and international market entrants into UK life sciences.
“The UK has a unique opportunity here – by bringing together its wealth of diverse population health data and working with the regulator, we can make it as easy as possible for promising treatments to pass through the different control mechanisms at each stage.”
Progress already made
The MHRA have already made headway towards delivering more streamlined and efficient approvals, which have contributed to exceeding the government’s ambitious target to reduce clinical trial set-up times to 150 days as part of its 10-year plan for the NHS.
Latest figures show the contribution of the MHRA and HRA reducing set-up times from 169 days to just 122 days for studies going through combined safety and ethical review. The combined review process conducted by MHRA and HRA takes an average of 41 days, less than half of the time it took a few years ago.
MHRA chief executive, Lawrence Tallon, said in a statement: “These reforms to clinical trial regulations are a boost both for patients and industry investment in R&D in this country. They will help to make the UK a more attractive, internationally competitive destination for both commercial and non-commercial clinical research.
“Most importantly, patients will benefit from earlier access to the latest, innovative medicines. We have listened carefully to the needs of patients, clinicians, researchers and industry to ensure we are delivering the most efficient, streamlined approvals process without compromising safety.”
