If you are not considering the UK for your next trial, you may want to think again. The UK has one of the biggest patient populations in Europe, and the British Government and the MHRA are now implementing a new series of measures aimed at making it faster and easier to gain approval and to run clinical trials in the UK.
The changes being implemented will make the UK one of the best countries in the world to conduct clinical research for patients and researchers and are the biggest overhaul of UK clinical trial regulations in over 20 years.
Under the new regulatory framework, the clinical trial application process in the UK will be more proportionate, streamlined, and flexible. For example, regulatory and ethical review of clinical trial applications will be integrated, and a single UK decision issued. In the pilot phase, this approach halved approval times for studies and cut the time from application to recruitment of the first patient by 40 days.
The MHRA will also implement a process to allow review of trial applications within 30 days of submission, with a maximum of 10 calendar days for a decision to be granted once the regulator has received any final information.
These changes will result in a regulatory framework that is as future-proof as possible, responsive to different types of trials, and supportive of both innovative trial designs and new ways of carrying out trials, such as decentralized trials.
The new regulatory framework supports a wider coordinated program of work that has been developed to ensure the Recovery, Resilience, and Growth of UK clinical research, as set out in the British Government’s vision for The Future of UK Clinical Research Delivery. Beginning in 2021, this plan sees the research ecosystem across the UK working together to achieve the aim of making the UK a world leader in efficient and cutting-edge clinical research. Phase 1 of the program has been completed, and phase 2 will continue until 2025 according to the implementation timelines.
LINK Medical can support you with your trials and sites in the UK!
Meet our experienced in-house CRAs located in the UK.
China Lloyd has experience working on studies in several indication areas including oncology, women’s health, and transplants. She has a background as a midwife and as a specialist research administrator within the NHS. In addition, China has in depth experience conducting clinical trials in the UK. She has a Bachelor of Science, Midwifery and a Bachelor of Science, Applied Health Studies from Anglia Ruskin University, Cambridge, UK.
Mihaela Petrica has over 4 years of experience in clinical trials and has worked with several oncology studies as well as studies in paediatrics , ophthalmology, gastroenterology, neurology, haematology , and cardiology. She has a noteworthy background in linguistics and has performed co-monitoring with junior CRAs in her role as senior CRA. Mihaela has a BA in Philology and a MA in Comparative Literature from the University of Bucharest, Bucharest, Romania.
Both China and Mihaela have experience with the regulatory system in the UK and work closely with our central Study Start-Up (SSU) group for new projects.
LINK Medical – your strategic partner
LINK Medical has a strong in-house network of experts in all key functions needed for clinical research and development, including medical and strategic advice, medical writing, regulatory and study start-up, in addition to project management, biometrics, and biostatistics. LINK Medical also has a dedicated medical device group and a department working specifically with RWE and observational research. We offer a well-integrated local presence in the Nordics, UK, and Germany. Reaching from early phase development to post-marketing, we provide expert guidance across every aspect of a project – all from ONE source.
Contact us today to learn more how we can support your product development.