The unprecedented challenges of the last 18 months have
shone a spotlight on UK clinical research. Through a
heightened spirit of collaboration and innovation, the
healthcare professionals, researchers, participants,
regulators, medical charities and industry who make up our
research ecosystem have made a huge contribution to the
global effort on therapeutics and vaccines.
As we look forward, there is an opportunity to build on
what we have learned and achieved and realise a bold and
ambitious vision of clinical research delivery. The
recently launched implementation
plan for the government’s Recovery, Resilience and
Growth (RRG) programme for UK clinical research, sets out
the steps being taken over the next year, backed by over
£64 million of government funding, to begin to turn the UK
vision for clinical research delivery into a reality.
The Medicines and Healthcare products Regulatory Agency
(MHRA) is playing a pivotal role helping to ensure that the
UK remains one of the best places in the world to deliver
safe, cutting-edge research. Part of this work is the
combined review, which will provide a more streamlined and
efficient service for research applicants. From January
2022, all new Clinical Trials of Investigational Medicinal
Products (CTIMPs) in the UK will be subject to a combined
review from the MHRA and the UK Research Ethics Services,
in collaboration with the Health Research Authority (HRA),
facilitating rapid start up and benefitting patients
sooner.
Applicants need only make a single application for both
Clinical Trial Authorisation and Research Ethics Committee
(REC) opinion and approval is delivered together. A number
of sponsors have already used this new process with some
reporting a 30 per cent improvement in overall trial set up
times.
This work is part of the transformation of the Integrated
Research Application System (IRAS). We are collaborating
with the HRA, the devolved administrations, the National
Institute for Health Research (NIHR) and other research
partners to create a world-class hub for health and social
care research in the UK, with smooth and intuitive access
to research approval, study management, best practice
guidance and lay-friendly information about the results of
research.
We’ll provide further information on any changes
researchers and/or sponsors need to make in good time,
including how applicants can access support with the new
system.
However, applicants are encouraged to start using the
service now so they can ensure their internal processes and
systems are aligned for January 2022, when all approvals
for CTIMPs will be processed via the combined review. Get
started now by visiting https://www.hra.nhs.uk/combined-review.
