Last week (17th January 2022), the MHRA published an updated set of proposals outlining their recommended changes to clinical trial regulation in the UK. These changes will look to replace the current Medicines for Human Use (Clinical Trials) Regulation 2004. As part of the publication, they are seeking feedback from stakeholders across the industry.
You can download the full proposal document from the UK government site here.
The proposals outlined are far reaching and cover a broad range of regulatory areas from approvals through to manufacturing. For the purpose of this post though, I want to focus on some of the data management considerations which will potentially impact clinical trial sponsors and CROs in the coming years.
Accessibility, Transparency and Innovation in Clinical Trials
The proposals place great emphasis on facilitating drug development, enhancing transparency and removing obstacles to innovation. In particular in the section on ‘Research Transparency’, reference is made to the plan to:
‘In line with international standards, introduce a requirement to register a trial in a World Health Organization compliant public register prior to its start and to publish summary of results within 12 months of the end of the trial…’
There’s a clear push towards sharing research findings, mirroring efforts in the EU with the launch of CTIS. It’s also similar to that which we’ve seen in other areas of research with the ARCHIVER project in support of the European Open Science Cloud (EOSC).
In order to fully realise this vision, this valuable research data must be kept in searchable, accessible and preserved archives. This stretches beyond summary documents, like those which will be captured in the WHO’s register.
The challenge to consolidate this data into a single and usable system, with the appropriate technology in place, will be critical to benefitting from this open research.
Update to Good Clinical Practice (GCP)
The MHRA have confirmed their commitment to follow the ICH’s GCP principles, but will also be developing their own set to provide flexible guidelines which will apply to a broad range of clinical trials.
Specifically in regard to data archiving, they have confirmed their intention to align the Trial Master File (TMF) retention period to EU Regulation 536/2014, that is that it must be kept for at least 25 years. They have also stated that the file must be directly accessible to MHRA inspectors for the duration of that period.
This reinforces the responsibility of sponsors to ensure that their archived eTMF and clinical study data is preserved and accessible for at least 25 years. Data kept for this period of time is at serious risk of loss, corruption or format obsolescence unless appropriate preservation actions are undertaken. Arkivum have written about this extensively in the past, and I would highly recommend reading our eBook on preserving the eTMF if you haven’t already done so.
I think it is worth adding that throughout the proposal – and specifically in relation to the TMF – the MHRA have referred to the idea of proportionality in how the regulations are created and applied. I will be interested to see the impact of this approach in the coming consultation period and publication of the revised regulations.
The ‘Huge Increase’ in Electronic Systems as Part of Clinical Trials
Another area covered within the section on GCP was the increase in the use of electronic systems as part of the clinical trial process. It is not secret that the COVID-19 pandemic has accelerated digital transformation across life sciences, and this update is a recognition from the regulators to this change (in many ways started by 2021’s Medical Device Regulation).
The proposal states that many of these systems have a: ‘direct impact on patient safety, data integrity and protocol compliance.’
The result of this is that the updated regulations will introduce legislation over the design and use of these systems and perhaps most importantly, placing responsibility on service providers to follow and align themselves to GCP principles.
For any sponsors or CROs operating within the UK, it is worth taking note (if not already) that any systems that are currently, or will be using in the future, should follow GCP principles and guidelines.
Next Steps for the MHRA’s Clinical Trial Regulation Proposal
I have of course only covered a small segment of the proposals and would encourage you to have a read of the full document on the government website. For those interested, the MRHA have set a deadline of the 14th March 2022 to provide feedback on the proposal.
I am very interested in the future of these regulations, and the direction that they will take. I’ll be keeping a close eye on any announcements and Arkivum will continue to provide relevant updates where appropriate.
If you have any questions about anything that I have covered in the post, please do not hesitate to get in touch with me at Tom.Lynam@arkivum.com.
27 Apr, 2021
FAIR data principles, what are they and how can they support compliance?
18 Feb, 2021
New eBook: An eTMF Archiving and Preservation Guide
08 Jun, 2021