As you’re probably aware there is a lot going on in the world of GCP at the moment, and so I wanted to summarise some of the forthcoming changes which I’ve been reflecting on in recent months. There’s a lot of additional information in each of the documents I’m discussing here, but I thought it might be helpful to provide a summary of my main impressions from each one.
I’d also love to hear your views so please do comment below on your own thoughts and concerns on these topics.
1. New UK Legislation
The Medicines and Healthcare Products Regulatory Agency has published its response to their consultation (run in Quarter 1 2022) on proposed changes to UK legislation for Clinical Trials post Brexit. There will be over 30 changes which they’ve summarised under various topic headings. Many of these are in line with the changes we are seeing across the GCP landscape, and implementing measures to keep in line with international standards.
As with many other regulators there is likely to be an increased emphasis on Risk Assessment and risk based approaches to management of clinical trials. They want to allow for flexibility across a spectrum of risk, rather than a binary (high vs low risk) categorisation.
The first step towards this has been the introduction of a Notification Scheme for the lowest risk clinical trials, which was launched on 12 October.
2. O’Shaughnessy review of Clinical Trials in the UK
This report, commissioned by the UK government early in 2023 contains the results of an independent review of commercially sponsored clinical research in the UK and recommendations to improve the landscape. The background to this was a significant drop in commercial clinical trials in the UK between 2017 and 2022. The report contains a total of 27 recommendations listed under headings outlining the problems Lord O’Shaughnessy identified and suggesting actions to address these problems. The main areas covered by these recommendations are the infrastructure for research within the UK Health Service, the prioritization of commercial clinical research in the UK and patient and public awareness and perceptions. Lord O’Shaughnessy states that the ultimate aim should be to double the number of participants in commercially sponsored clinical trials twice by 2027.
3. Draft Version of ICH GCP Revision 3
This long anticipated document provides the first look at this important update. There’s a huge amount of change and it will be interesting to see what the final version looks like when it is published following the consultation and finalisation period. There’s a very helpful blog post by Andy Fisher of the MHRA which is linked below – this covers the details of all the proposed changes and I don’t intend to go over all of this now, but rather to try to outline the philosophies behind some of the changes.
There’s now a much stronger link between this document and the ICH guideline ‘General Considerations for Clinical Research’ (E8). This can be seen in references to Quality by Design, Critical to Quality Factors and stakeholder engagement, including patient representation.
Generally the approach is to allow more flexibility in application of GCP based on trial design and risk assessment. This can be seen particularly in the section on Essential Records (Appendix 3 to Annex 1) with a change from a prescriptive list of documents towards advice on identifying which records will be required for each trial.
There is also, predictably, quite a bit of change with respect to management of electronic data and records, including a whole new section on Data Governance which outlines the responsibilities of Sponsor and Investigator.
Many of the updated documents we are seeing are formalising changes which have been happening in our industry for several years, for example patient engagement and risk based quality management. There are also new requirements in the areas of transparency, diversity in participant population and use of Real World Data and Real World Evidence. Keeping up to date is as difficult as ever, but if we work together and keep communicating I believe we can improve clinical trials for everyone.
MHRA document on new legislation for clinical trials https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1144407/Clinical_Trials_Final_government_response_to_consultation.pdf
MHRA Notification Scheme https://www.gov.uk/government/news/new-streamlined-notification-scheme-for-lowest-risk-clinical-trials-marks-start-of-mhra-overhaul-of-regulation
O’Shaughnessy report into commercial clinical trials https://www.gov.uk/government/publications/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review/commercial-clinical-trials-in-the-uk-the-lord-oshaughnessy-review-final-report#executive-summary
Draft version of ICH E6(R3)
https://database.ich.org/sites/default/files/ICH_E6%28R3%29_DraftGuideline_2023_0519.pdf
Andy Fisher’s blog post summarising all the changes https://mhrainspectorate.blog.gov.uk/2023/05/26/ich-e6-r3-good-clinical-practice/