The UK is set to usher in the largest package of reforms to clinical trial regulations in more than two decades.

The Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) announced the changes will come into effect today, saying patients will get access to new treatments faster but still safely.

Reforms 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 modification to be approved quicker, whilst maintaining the highest safety standards.  

The two bodies said these will make it simpler to start lower-risk studies, strengthen support for early-stage research and embrace new approaches. These include use of early safety data from overseas studies that meet UK standards and computer model simulations to predict how new medicines may behave before they are tested in patients. 

Clinical trials reforms can help attract inward investment and innovation

Gerard Hanratty, Partner and Head of Health and Life Sciences at UK and Ireland law firm Browne Jacobson, 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.

“For patients, breaking down barriers to participation in clinical trials could also have a profound impact on tackling health inequalities, as widening and diversifying the pool of participants will ensure new treatments are being tested on people from all walks of life rather than a narrow sample.

“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.

“The key aim of UK regulatory change must be to make it easier for the NHS to adopt and use emerging technology. Change is happening at speed, but we must be able to fast-track the integration of new systems. These reforms are a meaningful step in that direction, and they send a clear signal globally that the UK is serious about its ambitions as a leading destination for clinical research.

“Alongside the new framework, the clinical trial community will hope to see clear, concise and pragmatic guidance to help companies prepare for the upcoming changes. A well-resourced and highly skilled MHRA remains an absolute priority for the industry in order to effectively implement the intended reform.

“Adequately funding and empowering the MHRA will be critical to enabling faster approvals, fostering international collaboration and ensuring the UK remains competitive in attracting cutting-edge solutions.”

Browne Jacobson recently published a white paper, titled Advancing inward investment into the UK health sector, in partnership with Healthcare World. This sets out eight recommendations – spanning legal, procurement, data, workforce and business development issues – which could help to position the NHS as a premier destination for foreign direct investment.