Will Cragg

It was a lot of fun to do this podcast episode with Ella - and if you don't fancy my episode then there are plenty of others to choose from!

MHRA's intended take-home message from today's GCP symposium was, they said, "risk proportionality" in clinical trials - definitely welcome. Still some questions around how it will look in practice, but guidance to follow

Yes - although it might not count for much, perhaps nice that the issue has gone on record as part of this debate.

Yes, brilliant!

And that's a wrap! Regulations passed. That was indeed a more expansive discussion than last week in the Commons and just about worth the listen! Encouraging to see the work of the Lords in action - not many there, but clearly some research done and thought put into the questions

She was unable to reply to the question about environmental impact of trials but said she would write back separately

Re stakeholder consultation and avoiding unintended consequences - she gives the example of the consultation resulting in patient and public involvement being excluded from the regulations, but supported by suitable guidance instead

Regarding automatic approvals: new regs ensure only appropriate trials will be able to follow this route. Criteria designed in consultation with suitable experts in trials. She confirms that any safety concerns with medicinal products will make the trial ineligible for the notification scheme

Regarding MHRA performance, she mentions that MHRA has been doing well vs statutory timelines for review. New regulations will include measures to make approvals quicker

Regarding implementation: guidance accompanying the regulations will be published before the regs come into force. Working with research community to ensure guidance is 'clear and helpful'

Criteria for low-risk trials - designed so that applicable trials are already supported by enough evidence about safety and efficacy.

She mentions the consultation with various groups across the research community. Plan to continue working with the community to produce guidance around the regulations.

She addresses the point about protection of intellectual property. New regulations will allow for deferral of registration and results sharing. Deferrals can be granted for up to 10 years

She says MHRA will still maintain high standards and oversight of patient safety - but regulations remove requirements that serve no useful purpose. She reiterates the new transparency requirements, including about sharing trial results with participants.

Baroness Merron replies. Expresses appreciation for supportive comments. Reiterates intentions of the new regulations.

Speaker has talked to Teenage Cancer Trust about involving more younger people in research (as participants) - has Government consider needs of this population?

And might the rules have unintended consequences on trial designs? (I didn't totally follow this point)

Speaker supports the transparency measures - registering trials and reporting all results. Still a need to handle confidential information properly (IP, participant data) - what safeguards will there be?

Regarding 'automatic' approval for low-risk trials - possible unintended consequences? Could it raise concerns about oversight and monitoring? Will there be appropriate scrutiny?

Next speaker (not government): mentions Covid research and need to balance safeguards with benefits of (quick, efficient) research; importance of risk-proportionality. Again worries about the risks of combined review being under-resourced

And finally, what consultation was done and what did different groups in the consultation say?

Next questions (not the minister), supporting aims of the regulations, but: a) will MHRA and REC by resourced well enough? b) how will risk-proportionality be operationalised? c) how will international alignment be monitored? d) how will impact of regs on trial efficacy and safety be monitored?

She finishes by talking about the role of animal testing in trials especially given low success rate of new medicines - could this be improved?

She says there's disappointingly little about environmental impact of trials - pleasingly, she mentions work by @ukctunetwork.bsky.social and @icr-ctsu.bsky.social about greener trials

Natalie Bennett (former leader of Green Party) speaks - welcomes transparency angle, given previous issues with this in trials. Questions whether low-risk really means low-risk in the risk-proportionality rules. Pleased about development of guidance about diversity and inclusion

From research to reality | Reports | Wellcome This report sets out a vision for science to be embedded at the heart of the UK National Health Service (NHS).

Mention of benefit to NHS from research; perhaps they might allude to Wellcome's neat 'research to reality' idea as an additional mission? wellcome.org/reports/from...

More or less same speech as given last week in Commons (perhaps slightly slimmed down). Emphasising risk proportionality, futureproofing, international alignment, cementing UK as destination for clinical trials, increased transparency.

At least 2 of us in the audience then!

Starting now. Speech first by Baroness Merron (Labour).

Got the feed running for the two pieces of legislation first in the agenda (on unrelated topics). Discussion seems a little more expansive than the House of Commons committee was last week, so perhaps some chance of thoughtful commentary? That said, there seem to be only about 5 people in attendance