A faster path to UK trials approvals: CTIMP review service launches
On 01 January this year, the Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) completed the roll out of their new combined review service for researchers seeking approval for the nearly 1000 Clinical Trials of Investigational Medicinal Products (CTIMPs) reviewed every year. The launch resulted from the collaborative efforts of the HRA and MHRA to contribute to the UK’s vision for life sciences, in particular building on the strength of the UK as a place to conduct research.
In this joint blog, Catherine Blewett, Senior Development Manager at the HRA, and Martin O’Kane, Head of the MHRA Clinical Trials Unit, fill us in on the new process, which will lead to faster approvals.
The process as it was
Martin:
Historically, applications for CTIMPs came separately to the MHRA for regulatory approval, and to a research ethics committee for ethics approval. Applicants could make both submissions at the same time, or in sequence, but approval from both bodies needs to be in place before a trial can begin.
What this meant was that a) applicants were having to submit duplicate information to the two bodies and b) applicants would sometimes be required to resubmit two sets of documentation when changes were made. For instance, if you received approval from MHRA, but then questions were raised during the research ethics committee review, you may have needed to apply for a ‘substantial amendment’ to the authorisation.
Issues like these led us to look at ways we could streamline the process to reduce those kinds of delays to starting a trial and, ultimately, get medicines to patients that need them faster.
Evolution to a new system
Catherine:
The combined review service provides a central UK portal, the Integrated Research Application System (IRAS), with a single place for applications for approval of CTIMPs and, indeed, combined Device/IMP trials. In the background, we then have a coordinated review by both the MHRA and the research ethics committee, resulting in either a combined approval for that trial, or questions being agreed between the two organisations and raised jointly.
It’s worth mentioning that, while, as of 01 January, this is the only route for all CTIMP approval applications, it’s not a new service as such. In fact, we’ve offered this as a voluntary service for almost four years and, as a result, we’ve been able to develop and refine both the process and the system that supports it. We’re very grateful to the willing group of early adopters that have been using the system for some time already – they’ve given us valuable stakeholder feedback that helped inform the requirements for the system and allowed us to take an agile approach to developing a solution that was scalable. It’s also been a real UK-wide effort to drive this forward, as the National Institute for Health Research (NIHR) and the devolved administrations have all played their part.
Benefits of the new joined-up approach
Catherine:
One of the key benefits of the more streamlined approach is the coordinated feedback applicants receive. Where there are questions that need to be addressed, the applicant receives one agreed list of actions they need to take. Any changes to documentation can then be made once, cutting out any duplication of effort. This speeds up the process and gives applicants a clearer route to approval. The time it takes to complete the approval process can vary depending on the complexity of the application, but our comparisons have shown that we have halved the approval time with combined review, compared to 2018 with separate review.
Martin:
For the MHRA and the HRA, having this closer working relationship between the organisations also means the advice that we can give sponsors is more consistent, joined up and harmonised. And it means that the reviewers have the assurance of knowing that all aspects of the application are being reviewed at the same time, and that there can be a joint discussion on outcomes with their counterparts where necessary.
Ultimately, this aligns directly with the UK Life Sciences Vision and Saving and Improving Lives: The Future of UK Clinical Research Delivery. A key theme of these is the vision for more streamlined, efficient and innovative research, so this plays directly into that effort to build on the UK’s leading position in life sciences globally. In fact, as IRAS is developed further to encompass all other areas of research, we think this may eventually become a globally unique offering for researchers.
Practicalities and tips for new approaches
Catherine:
When an applicant makes a submission via IRAS, the form is broken down into modules, so they will be taken through the various questions once, including all the questions on clinical aspects and ethics. After submission, the relevant information comes to each organisation for review.
One thing this does mean for applicant organisations, is that they may need to adjust their ways of working a little, to think more holistically about their application. In the past, one team in the organisation may have handled the application to the MHRA, and a different team may have handled the ethics committee submission quite separately. Where this has been the case, we’d encourage organisations to think about how those teams can work more closely together to take a more joined-up approach to their single application.
Martin:
Lots of information is available on the HRA website for sponsors and investigators to familiarise themselves with the new process.
In particular, the HRA have been running webinars throughout December and January, and recordings of these are available to watch on-demand. There’s also support for first-time users of the system, and we’d encourage people to get in touch directly to talk through any questions.
Find out more: www.hra.nhs.uk/combined-review
About the MHRA – The MHRA is an executive agency, sponsored by the Department of Health and Social Care. It regulates medicines, medical devices and blood components for transfusion in the UK.
About the HRA – The HRA protects and promotes the interests of patients and the public in health and social care research, including by making sure that research is ethically reviewed and approved. It is one of a number of organisations that work together in the UK to regulate different aspects of health and social care research. Most of their functions apply to research undertaken in England, but they also work closely with the other countries in the UK to provide a UK-wide system.