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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

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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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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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

Should we use generative AI to write participant information for clinical trials? Writing participant info can be tricky to do well, and AI could certainly take some of the effort out of drafting content or suggesting improvements to it. However, there are some reasons to be cautious.

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Liam Bishop @liamhbishophealth.bsky.social · 03/01/2025

Hopeful and excited that fresh and new ideas will come through this call-out from TRIALS for papers on ‘Improving equity, diversity and inclusion in randomised trials’ www.biomedcentral.com/collections/... 💡New ideas are exciting - tell me yours!

biomedcentral.com

Improving equity, diversity, and inclusion in randomised trials

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Will Cragg @willjcragg.bsky.social · 02/01/2025

Still 8d to do this HRA consultation. I've replied & agreed the proposal sounds 'okay'. Main suggestion from me was to check that reliance on verbal consent, with likely process burden around it, is definitely better than efficient/flexible written consent methods (especially with rise of eConsent)

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Will Cragg @willjcragg.bsky.social · 02/01/2025

Potentially interesting paper (not read yet) on uses of large language models like ChatGPT in informed consent for research. Can we trust these methods to be used without human supervision? At what point could potential benefits outweigh risks? journals.sagepub.com/doi/full/10....

journals.sagepub.com

Sage Journals: Discover world-class research

Subscription and open access journals from Sage, the world's leading independent academic publisher.

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Will Cragg @willjcragg.bsky.social · 20/12/2024

Starting to get into the proposed changes to UK clinical trials regulations then... one immediate impression is that the changes aren't obviously radical. For one thing, it's more amendments to the 2004 law rather than something totally new. But perhaps some of the minor changes could be impactful?

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Will Cragg @willjcragg.bsky.social · 18/12/2024

Here's an update from the Persevere project via the @ukctunetwork.bsky.social website, including the important question of 'what is it'… briefly, Persevere is about why and how we should aim to prepare well for different sorts of 'participation changes' in trials ukcrc-ctu.org.uk/update-from-...

ukcrc-ctu.org.uk

Update from the PeRSEVERE Project – UKCRC

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Reposted by Will Cragg

StatsCI @statsci.bsky.social · 16/12/2024

Do carrots or mince pies improve reindeer performance? 🦌 & how can #estimands help Santa's delivery improvement research programme? Find out in ✨All I want for Christmas… is a precisely defined research question ✨ trialsjournal.biomedcentral.com/articles/10....

trialsjournal.biomedcentral.com

All I want for Christmas…is a precisely defined research question - Trials

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Will Cragg @willjcragg.bsky.social · 13/12/2024

Final Q about the most important aspects of the new guidance: want individuals to understand the guidance and take up the bits that make most difference to them; importance of inclusion and equity; and remembering the ultimate goals of improving lives and making the world a better place

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Will Cragg @willjcragg.bsky.social · 13/12/2024

Q about how midwives can be involved in trials? Aiming to get away from idea that trials occur away from healthcare systems - should be embedded. Healthcare workers of all kinds should be supported to help with trials - and perceived need for (disproportionate) GCP training should not be a barrier

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Will Cragg @willjcragg.bsky.social · 13/12/2024

Q how can the guidance support proportionate regulatory/ethical reviews? Important to value contributions of REC members; need national bodies to oversee RECs and support consistency and proportionality (while maintaining standards). Need to address risk of increasing complexity of systems over time

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Will Cragg @willjcragg.bsky.social · 13/12/2024

Interesting Qs about managing the adaptability/flexibility of the guidance (& similar changes in ICH GCP E6 etc). My thoughts...In some ways perhaps it's easier for regulatory guidance to say exactly what to do - flexibility gives opportunities but also anxiety of Are we doing the right thing?

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Will Cragg @willjcragg.bsky.social · 13/12/2024

Q what should people do in response to the new guidance? 1) be aware of it; 2) read it and consider how you might change what you do; 3) planned/ongoing engagement between WHO and national-level regulators...

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Will Cragg @willjcragg.bsky.social · 13/12/2024

Q about how the new guidance can help generate evidence about treatments for rare diseases. This sort of research needs international collaborations, which the new guidance (and supporting WHO resolutions) will support

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Will Cragg @willjcragg.bsky.social · 13/12/2024

Some older guidance documents have perhaps gone out of date in terms of describing how data collected, approvals given etc - e.g. focus on paper-based methods. This new guidance will helpfully be more 'agnostic' about these sorts of methods

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Will Cragg @willjcragg.bsky.social · 13/12/2024

Q about how pharma and non-commercial trials can work in complementary ways - speakers support the value of both and are positive about the chances of complementarity. Confirm the view that neither type of research can answer all important research questions alone

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Will Cragg @willjcragg.bsky.social · 13/12/2024

Jeremy Farrar explains that although 'trial registries' could sound dull/bureaucratic, they are actually an important mechanism for democratising research

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Reposted by Will Cragg

Sarah Alderson @imp-sci-saraha.bsky.social · 13/12/2024

Listening into the @who.int new clinical trials guidance webinar. Great to hear they are recommending a patient-centric anpproach with community engagement throughout the trial process from early stage through to implementation of findings. #ClinicalTrials #ImpSci

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Will Cragg @willjcragg.bsky.social · 13/12/2024

Jeremy Farrar of WHO talks about how artificial intelligence could affect clinical trials - it will need to be done ethically, but can't be ignored

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Will Cragg @willjcragg.bsky.social · 13/12/2024

In some ways, patient and public involvement is perhaps a 'no brainer'! - But it's come a long way. Great to see the emphasis given now to community engagement in the WHO guidance.

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Will Cragg @willjcragg.bsky.social · 13/12/2024

Vasee Moorthy of WHO talks about the need for proportionate clinical trials training - and not being too led by ICH GCP in all settings/trial types given its origins in the world of drug development

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Will Cragg @willjcragg.bsky.social · 13/12/2024

In the @who.int webinar on new guidance for best practice in trials. Same (great, important) messages we've been hearing for years- avoiding research waste, value of transparency, inclusivity, proportionality etc. Obviously not there yet but hopefully this new guidance will keep up the pressure!

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Will Cragg @willjcragg.bsky.social · 13/12/2024

Exciting news that the new UK clinical trials regulations have been laid in parliament, and gives me an opportunity to understand what that actually means! Mainly interested in when I can see the text, and I think the general answer is 'soon'

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Suzie Cro @suziecro.bsky.social · 04/12/2024

📅SAVE THE DATE(s) & spread the word about the ***2nd Contemporary Clinical Trials Methodology Meeting*** from ICTU & NIHR RSS Imperial and partners hub, 2nd & 3rd April 2025. Register interest here: bit.ly/3Zg7yUn More details with booking link coming soon!

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Will Cragg @willjcragg.bsky.social · 03/12/2024

HRA seeking views on effectively verbal consent for some low risk medicine trials, deadline 10th Jan. Step in an interesting direction. Wonder if we might eventually see some lowest-risk trials being opt-out rather than -in? Obviously a few steps away from that still www.hra.nhs.uk/about-us/new...

hra.nhs.uk

Simplifying the process of seeking and recording consent in low risk clinical trials

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Will Cragg @willjcragg.bsky.social · 30/11/2024

Aiming to keep learning about artificial intelligence (including via stuff shared here). Partly just interested in how AI will change how trials are run. But also my job is a bit like an exam (not unpleasantly so!) where I could get asked to advise about anything anytime so I'd better be prepared!

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Will Cragg @willjcragg.bsky.social · 29/11/2024

Some interesting points and potential applications in this NICE position statement on use of artificial intelligence in evidence generation www.nice.org.uk/corporate/ec...

nice.org.uk

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Katie Gillies @katiegillies.bsky.social · 19/11/2024

I'm pretty new to Bluesky and haven't found all the trials methods researchers yet! Trying to bring us all together in one place for others to find & fill my feed with all things trials. Please feel free to share and let me know if you'd like added. go.bsky.app/AsP6Yta

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Will Cragg @willjcragg.bsky.social · 23/11/2024

Hi everybody! Although a bit of a shame to lose some of the previous connections, a fresh start over here is quite welcome. Nice to see familiar names/faces and thanks to @katiegillies.bsky.social for helping get things going! Also intrigued by the possibilities of a whole 20 more characters...

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