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

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!

Leeds CTRU@leedsctru.bsky.social · last yr.

PhD Student, Ella Howes, has just released the latest episode of the Trials Methodology podcast with our very own @willjcragg.bsky.social , covering all things to do with the 'how' of trials methodology💡 Give it a listen here (or on Apple podcasts if you prefer): open.spotify.com/episode/04JZ...

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

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

Lords Grand Committee

parliamentlive.tv

New clinical trials law being debated at 6pm today (UK time), in case you're feeling super keen... committees.parliament.uk/event/23258

3 February 2025 - The draft Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 - Debate - Committees - UK Parliament

18:00 - Room 11, Palace of Westminster

committees.parliament.uk

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

nihr.ac.uk

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/

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...

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.

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!

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)

Will Cragg@willjcragg.bsky.social · 2y ago

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...

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....

Sage Journals: Discover world-class research

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journals.sagepub.com

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?

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-...

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....

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

trialsjournal.biomedcentral.com

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

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

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

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?

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...

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

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

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

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

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

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

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.

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