Will Cragg
@willjcragg.bsky.social
Clinical trials quality assurance manager, sometime methodologist, Leeds CTRU. Views my own. Motivated to make trials ethical, efficient & a good experience for participants. Brummie of sorts (#UTV), based in Sheffield
Yes - although it might not count for much, perhaps nice that the issue has gone on record as part of this debate.
February 10, 2025 at 5:24 PM
Yes - although it might not count for much, perhaps nice that the issue has gone on record as part of this debate.
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
February 10, 2025 at 5:21 PM
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
February 10, 2025 at 5:18 PM
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
February 10, 2025 at 5:17 PM
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
February 10, 2025 at 5:16 PM
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
February 10, 2025 at 5:14 PM
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'
February 10, 2025 at 5:13 PM
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.
February 10, 2025 at 5:12 PM
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.
February 10, 2025 at 5:11 PM
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
February 10, 2025 at 5:10 PM
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.
February 10, 2025 at 5:08 PM
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.
February 10, 2025 at 5:06 PM
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?
February 10, 2025 at 5:03 PM
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)
February 10, 2025 at 5:02 PM
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?
February 10, 2025 at 5:02 PM
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?
February 10, 2025 at 5:00 PM
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
February 10, 2025 at 4:58 PM
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?
February 10, 2025 at 4:55 PM
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?
February 10, 2025 at 4:55 PM
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?
February 10, 2025 at 4:52 PM
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
February 10, 2025 at 4:50 PM
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
February 10, 2025 at 4:49 PM
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