I recently watched the MHRAs annual GCP Symposium, which, for obvious reasons took place online this year. The last one I attended was in February 2020, just before Covid hit the UK. That event was in person and involved the FDA as well as the MHRA. This year Health Canada also joined the platform and it’s great to see the international collaborations continuing in our post Brexit world.
I’ve only watched the first two days as the laboratory sessions are not of so much interest to me personally, and time is always short, so my reflections are only on the GCP sessions, not including the Bioavailability/Bioequivalence sessions.
Day one covered Resilience, Risk Based Quality Management, Real World Data and Real World Evidence (RWD/RWE) and Decentralised Clinical Trials. It was very interesting to hear the different regulators’ experiences and ideas, and I found it rather comforting that I didn’t really hear much that I haven’t been aware of already. The regulators do seem to be largely on the same page with a few minor differences. I did find the session on RWD and RWE very interesting, as this is a new area for me and the guidances being produces by FDA and MHRA are helpful.
Day two covered the changes at the three agencies following the Covid pandemic, including changes to the way clinical trials have been conducted over the last two years and the need for remote approaches to inspections. All three agencies have adapted and seem supportive of methods for conducting trials remotely, provided appropriate risk assessment and management are in place for GCP compliance. All three agencies have updated guidance and regulation accordingly and more change is on the way.
I’m going to focus on MHRA as this is where the most change will happen, mainly because of Brexit combined with Covid. MHRA has already produced guidance on Risk Adapted approaches to management of clinical trials and RWD/RWE. There is a Patient Involvement Strategy pilot in collaboration with the Health Research Authority (HRA), which is currently collecting information on how sponsors have involved patients in trial design and planning. Transparency is being addressed now with automatic registration of all Clinical Trials with Investigational Medicinal Products (CTIMPs) in the ISRCTN database (by the HRA). MHRA’s aim to streamline the approvals processes in the UK is being implemented via the Combined Review process, which is currently in place for all CTIMPs, along with a pilot scheme for combined IMP/Device trials.
MHRAs consultation on the new Clinical Trials legislation for the UK is now closed, but their priorities for the new law are:
• Patient focus
o Involvement in research planning
• Streamlined processes
o Combined Review
• Risk proportionality
o Risk adaptation, avoiding a one-size-fits-all approach
o Potential notification scheme for low interventional trials
o Flexibility – able to adapt to innovation
o In line with international standards
I may have missed it, but I don’t think any timeline was given for when the new legislation might be in place, but I’m very interested to see the final result.