Following on from the EU Clinical Trial Regulation update, our Regulatory Team focus on the Combined Review process in the United Kingdom.
What is the Combined Review Process?
Combined Review has become the new route for the submission of Clinical Trials of Investigational Medicinal Products (CTIMPs) within the UK since 01 January 2022 and is applicable to all initial CTIMP applications from this date with the aim of making the UK a more competitive arena for clinical trials. Combined Review is currently only applicable to initial CTIMP applications with ongoing CTIMPs currently remaining out of scope of the process but will be migrated into the system at a later date which is still to be confirmed.
Combined Review streamlines the application and approval processes for clinical trials in a similar way to the newly introduced EU-CTR by providing a combined review of the CTIMP application by both the MHRA and Research Ethics Committee (REC), leading to a single UK decision on the trial. To enhance efficiency, a single submission for a CTIMP incorporating the requirements of both the MHRA and REC is prepared and submitted in a new part of the Integrated Research Application System (IRAS), which is the existing system for REC applications. Under Combined Review, there is no provision to be able to submit the applications to the MHRA and REC separately as was previously the case.
IRAS which underpins the Combined Review process acts as the system for the initial application and subsequent management during the life cycle of the clinical trial. Individuals involved in initial applications or lifecycle activities for CTIMPs must have an account in the new part of IRAS to be able to participate in the preparation and/or submission of an application. There are several roles within the IRAS system which can be assigned to a user. This in turn provides the user with different responsibilities which allows the user to be able to perform certain tasks within the system.
Transparency of clinical trials has always been a priority within the UK, with the requirement for a clinical trial to be registered on a publicly accessible database being a condition of a favourable opinion given by the REC. Combined Review will further improve procedures around transparency with the registration to the publicly accessible ISRCTN Registry database now being made automatically by the Health Research Authority (HRA) as part of the Combined Review process without the need for the Sponsor to register the trial separately themselves.
Although there are currently no changes to the regulatory requirements associated with a CTIMP application following the introduction of the Combined Review process, a public consultation on a set of proposals to improve the clinical trial legislation in the UK has begun and changes are anticipated to the requirements in due course, so watch this space!
How can S-cubed help you?
We can prepare and coordinate all the necessary regulatory documentation you may require for a CTIMP in the UK, including IMPDs and IBs and ensuring these meet the relevant UK requirements. We can also support the submission through to determination within IRAS, and throughout the life-cycle of the trial.
If you have any questions on this topic, please don’t hesitate to ask. You can contact us through our website, via email (firstname.lastname@example.org), and telephone (S-cubed Ltd: +44 1235 77 22 60).