Major progress has been made in delivering a more efficient and
adaptable regulatory framework for clinical trials, the Chief
Executive of the Medicines and Healthcare products Regulatory
Agency (MHRA) has reflected on International Clinical Trials Day.
New regulations –
which represent the most significant update to the UK clinical
trials landscape in 20 years – are designed to put participants
firmly at the centre of how trials are run, while supporting
faster, more streamlined approvals, making it easier to test new
treatments in the UK.
Lawrence Tallon, MHRA Chief Executive said:
I've experienced first-hand the life-changing impact clinical
research can have on patients and their families. This, combined
with the benefits it brings to the economy, is why it's so
important we ensure the UK is one the most attractive places in
the world to conduct trials.
The UK is already a research powerhouse driven by innovation,
with one in eight trials in the UK testing treatments in humans
for the first time.
But we want to go further. Last month, we began implementing the
most significant update to UK clinical trials regulation in over
two decades. These reforms will address the research sector's
need for a more risk-proportionate regulatory framework for
clinical trials and will help get cutting-edge new treatments to
the NHS as quickly as possible.
Lord O'Shaughnessy, former health minister, senior
partner at Newmarket Strategy and author of the landmark report into
the UK commercial clinical trials landscape said:
The progress the MHRA has made in the two years since I published
my review has been remarkable. Despite its global reputation for
excellence, by 2023 trial approval set up times had slipped
badly.
The MHRA is now delivering consistently good approval times while
introducing further reforms to add speed and flexibility to the
process.
With a clear mandate from the Prime Minister to reduce trial set
up times to 150 days – which would be genuinely world-leading –
the MHRA is once again taking a global lead.
Professor Sir Martin Landray, Chief Executive of Protas,
said:
I am delighted with the progress the MHRA has made to deliver an
efficient and coordinated regulatory process for clinical trials.
Innovation in clinical trials is much needed if we are to find
better ways to prevent and treat the growing burden of common and
life-threatening diseases. The UK can be in pole position to lead
the charge, and regulatory enlightenment is a key part of this
journey.
Developed in partnership with the Health Research Authority
(HRA), and shaped by feedback from patients, researchers,
doctors, and industry, the new regulations will take full effect
from April 2026, following the 12-month implementation period.
To ensure these substantial reforms are phased in effectively,
the MHRA and Health Research Authority (HRA) will be producing
updated guidance. Already, the MHRA and HRA have launched a
pilot
Inclusion and Diversity Plan. Shaped by input from over 300
researchers, it offers practical guidance to help sponsors design
more representative studies, to ensure that trials represent the
populations they are designed to treat.
In the meantime, the MHRA has embedded improvements in processing
clinical trial applications into standard working practice, with
100% of clinical trials and investigations applications having
been handled within statutory timescales since September 2023.
Combined Review approval time with the Health Research Authority
is now at 60 days or less for all trials, with an average time
for Combined Review determination (including questions raised) of
40 days in March 2025.
Launch of consultation on use of real-world data
Beginning on International Clinical Trials Day, the MHRA is
launching a six-week
consultation on the use of real-world data for external
control arms of clinical trials, which has the potential to help
accelerate the approval of treatments, especially in cases when
randomised controlled trials may not be ethical or feasible. It
is another example of the work the MHRA is doing to support the
set-up of innovative trials.
Real-world data refers to information that is collected from
patients during the course of their normal clinical care. Data
can include electronic health records (EHR), disease and patient
registries, and patient reported outcomes (PRO) data, alongside
data from other sources. Once this data is analysed, the
information is referred to as real-world evidence (RWE).
The new guidance is for those planning a clinical trial which may
include a real-world data external control arm with the intention
of using the trial to support a regulatory decision on a medical
product. This means that a control arm of the study would use
data from patients not part of a specific clinical trial.
To access the guideline and participate in the consultation,
please visit the MHRA website.
Notes to editors
-
Today (20 May 2025) is International Clinical Trials Day,
which recognises the day the first randomized clinical trial
began in 1747. As part of celebrations, the MHRA is proud to
support the National Institute for Health and Care Research
(NIHR) in its #BePartofResearch
campaign
-
The Lord O'Shaughnessy
review into UK commercial clinical trials made 27
recommendations where action should be taken by the
government and delivery partners, including the Medicines and
Healthcare products Regulatory Agency (MHRA), to address key
challenges and transform the commercial clinical trials
environment. The Government has committed to implementing his
recommendations in full.
