New clinical trial regulations are set to come into force on 28 April.
The Medicines and Healthcare products Regulatory Agency (MHRA) and Health Research Authority (HRA) are introducing the largest package of reforms in over 20 years, which it is hoped will bring faster access to new treatments.
The 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.
It is hoped the changes will make it simpler to start lower-risk studies, strengthen support for early-stage research and embrace new approaches, including use of early safety data from overseas studies which meets UK standards and computer model simulations which can help to predict how new medicines may behave before they are tested in patients.
The latest figures show that clinical trial times are already reducing. Set-up times have decreased 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.
Dr Zubir Ahmed, Health Innovation and Safety Minister, said: “This is a landmark moment for patients, researchers, and our thriving life sciences sector that will make a real, tangible difference for thousands of people waiting for new treatments.
“By introducing faster routes for lower-risk trials, embracing modern technology, and making the system simpler to navigate, we are reinforcing the UK’s position as one of the most attractive places in the world to invest in cutting-edge research.
“The government set itself an ambitious target to cut clinical trial set-up times to 150 days — and I’m proud to say we’ve gone further and faster than that. We have driven those times down to just 122 days from 169 this time last year for commercial trials, meaning patients across the UK are getting the latest, most innovative treatments sooner than ever before.”
MHRA Chief Executive, Lawrence Tallon, said: “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.”
