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Will Cragg @willjcragg.bsky.social · 06/07/2026

We're seeking participants for the Y Survey, a short survey about why clinical trial participants stop or reduce their participation in clinical trials. Feel free to share. - More info in image - Survey link: app.onlinesurveys.jisc.ac.uk/s/leeds/y-su... - 84-second intro video: youtu.be/eAgOqO1LR9U

Invitation message to take part in the Y Survey. Full text as follows:

The Y Survey: a short survey about why clinical trial participants stop or reduce their participation in clinical trials

What is this?

The Y Survey aims to answer two main questions:
1. For anyone to give their view: why is it useful to know why clinical trial participants stop or reduce their participation?
2. For clinical trial statisticians: how do you use reasons for participation changes or reasons for missing data in your work?

The survey results could help improve how we collect data in clinical trials.

The results will also feed into future work about standardising reasons for participation changes. At the end of the survey, you can join a mailing list to stay in touch with this future work.

What’s involved?

• The survey is in two main parts. Both are optional.
• Each part may take around 10-15 minutes.
• Anyone can complete the first part, but only clinical trial statisticians are eligible for the second part.
• You can complete the survey on computer or your smartphone.
• You can save your survey progress and return to it later.

How can I find out more?

• You can see more information about this survey and consider taking part at: https://app.onlinesurveys.jisc.ac.uk/s/leeds/y-survey
• If you would like to see the survey questions first, go to: https://osf.io/6t723/files/ky32b
• The main researcher is Will Cragg, who works at the Clinical Trials Research Unit, University of Leeds (w.cragg@leeds.ac.uk).
• You can see Will briefly introduce the survey in this 84-second video: https://youtu.be/eAgOqO1LR9U (an audio version is also available at: https://osf.io/6t723/files/w6hjr).
• Please do share this survey invitation with others who might be interested.

This survey has been approved by the University of Leeds School of Medicine Research Ethics Committee (reference SoMREC 4172).

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Will Cragg @willjcragg.bsky.social · 25/03/2025

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!

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Will Cragg @willjcragg.bsky.social · 11/02/2025

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

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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'

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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.

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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?

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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?

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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...

wellcome.org

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).

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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.

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Will Cragg @willjcragg.bsky.social · 10/02/2025

At least 2 of us in the audience then!

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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

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Will Cragg @willjcragg.bsky.social · 10/02/2025

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

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Will Cragg @willjcragg.bsky.social · 10/02/2025

New clinical trial regulations going to the House of Lords today. Watchable via this link - sometime between 3.45 and 9pm...! www.parliamentlive.tv/Event/Index/...

parliamentlive.tv

Parliamentlive.tv

Lords Grand Committee

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Will Cragg @willjcragg.bsky.social · 03/02/2025

Look out for more exciting content like this to come when it goes through the Lords next week 🤪

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Will Cragg @willjcragg.bsky.social · 03/02/2025

And that seems to be the end of that! So... extremely surface level, a bit of discussion on technicalities and lots of information that is already available in press releases. I've never watched a parliamentary session before, so I don't know if that's normal or not!

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Will Cragg @willjcragg.bsky.social · 03/02/2025

Shadow speaker asks for further clarification and Government speaker says he will seek further information and reply separately

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Will Cragg @willjcragg.bsky.social · 03/02/2025

Response from Government speaker begins by addressing comment on recent AstraZeneca cancellation of investment in Speke factory; minister clarifies that costs and benefits to businesses will not be more than about £1M - hence below threshold for impact assessment

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Will Cragg @willjcragg.bsky.social · 03/02/2025

Question from Conservative (shadow) speaker - asking for clarification on a contradiction in the initial speech - significant benefit proposed, but not enough impact on business to justify full impact assessment?

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Will Cragg @willjcragg.bsky.social · 03/02/2025

(Interesting mentions of post-Brexit opportunity to create updated law - even though this new law will still be based on original pre-Brexit law)

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Will Cragg @willjcragg.bsky.social · 03/02/2025

Reiteration that 'participant safety remains paramount' (to finish intro speech)

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Will Cragg @willjcragg.bsky.social · 03/02/2025

Proposed benefits: greater access for patients to life-saving treatments; transparency (as above); clinical trials as part of the solution to resolve strain on NHS; broadening criteria regarding which healthcare professionals can be investigators

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Will Cragg @willjcragg.bsky.social · 03/02/2025

4) cementing UK as desirable destination for trials; 5) increased transparency - trusted info on clinical trials publicly available - legal duty to register trials, publish results and share results with participants

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Will Cragg @willjcragg.bsky.social · 03/02/2025

Key changes highlighted: 1) risk proportionality; including faster approvals and automatic approvals in some cases 2) futureproofing - moving away from one-size fits all approach; 3) international alignment (important!) with standards in other regions

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Will Cragg @willjcragg.bsky.social · 03/02/2025

Watching (slightly behind) - intro speech highlights the importance of clinical trials, and the aims of the amended legislation to make clinical trials legislation more flexible and streamlined, with patients' needs at the centre - also to put (/keep) UK at the forefront of trials activity

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Will Cragg @willjcragg.bsky.social · 03/02/2025

I'm probably going to listen (yes, it's come to this!) - I've heard the view the new law could go further in being even more streamlined, risk-proportionate etc. I'm interested in whether that comes across, or whether there will be concerns about the streamlining- or if they think it's about right.

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Reposted by Will Cragg

Louca-Mai Brady @louca-mai.bsky.social · 17/01/2025

UK #PublicInvolvement #PPI news: @nihr.bsky.social Centre for Engagement & Dissemination (formerly INVOLVE) to be hosted by @bmj.com group from 1/4. They will lead & coordinate 'Public Partnerships & Research Impact activities'. www.nihr.ac.uk/news/nihr-in... Will be watching with interest... #PPIE

nihr.ac.uk

NIHR to increase commitment to Public Partnerships and Research Impact with new Coordinating Centre contract

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Reposted by Will Cragg

Tim Morris @timpmorris.bsky.social · 17/01/2025

Stata users: if you want to make ‘kmunicate’-style Kaplan–Meier graphs, I’ve just released a Stata package on GitHub. To get it: . net from raw.githubusercontent.com/tpmorris/kmu... User feedback welcome! 1/

A vanilla KMunicate-style Kaplan–Meier graph from {kmunicate}. Key is the extended risk table showing the status of participants over time.

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Will Cragg @willjcragg.bsky.social · 17/01/2025

Discussion on the new UK clinical trials regulations in the House of Lords, this week (link below). Focus on the 'notification scheme' for lower-risk clinical trials, which is estimated here to include around 20% of clinical trial applications (!) publications.parliament.uk/pa/ld5901/ld...

publications.parliament.uk

House of Lords - Thirteenth - Secondary Legislation Scrutiny Committee

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Will Cragg @willjcragg.bsky.social · 16/01/2025

Yup, could do - and maybe (probably) AI methods could be taught to do participant info development better. I'm starting from a slightly sceptical position, having never used AI for this purpose...perhaps in a year or two I will feel differently!

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Will Cragg @willjcragg.bsky.social · 16/01/2025

So if AI made a start, it seems like many changes might be needed to align the AI output with quite a specific idea of best practice - as well as the probable need to check every word, just in case. Might this remove any benefit from using AI in the first place?

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