MHRA Overhaul in UK Clinical Trials Regulation: The Hurdle View

The Medicines and Healthcare products Regulatory Agency (MHRA) recently announced the most significant overhaul in UK clinical trials regulation in over 20 years.

The changes align with the needs and demands of the 21st century, making it faster and easier to gain approval and run clinical trials in the UK. The most exciting thing is that these changes will help to make the UK one of the best countries in the world to conduct clinical research for patients and researchers.

How will these changes impact the industry?

Historically, the process of obtaining regulatory approval in the UK has ranged from several months to years and can vary depending on the complexity of the trial. These changes simplify the application process and halve the approval times for studies, making it easier and faster for researchers to submit their proposals, accelerate the trial approval process and provide transparency to enable researchers to design and develop protocols for their trials effectively.

The simplified and streamlined regulatory change paves the path for faster patient access to treatments and medicine. 

What we’re doing at Hurdle to accelerate healthcare innovation

At Hurdle, we help our partners design and develop diagnostic testing strategies to execute their clinical trials. We provide them access to our laboratory partners and a range of at-home sample collection kits to enable decentralised clinical trials (DCTs). This is supported by our seamless automated fulfilment and logistics solution and a digital platform that offers visibility to patients’ testing journey. The change in the regulatory process can mean greater collaboration with our UK partners, as it provides the transparency we need to support the design and development of the protocol and enables us to provide additional information in real time for successful application approval.

Hurdle’s mission is to make healthcare more accessible and actionable. We want to ensure the timely availability of new therapies and treatments. Our approach to achieving this is offering our partners a cost-effective solution to DCTs that improves patient experience and accelerates trials. In addition, with DCTs, our partners can reach a more expansive and diverse population in their patient recruitment efforts and improve retention by removing the need for a physical site visit. Additionally, they can collect real-world data that is reliable and free from the typical bias associated with assessments performed in clinical settings.

All in all, we see this change in the regulatory process to be a step closer to improving the health of millions of patients.