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

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/...

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

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

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)

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....

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....

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

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!

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'

📅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!

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...

Suggestions?

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!

Welcome! @leedsctru.bsky.social 😀

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...

Learnt this week of ENHANCE guidance for communicating with families of deceased emergency research participants. Interesting, esp the tendency to avoid these conversations - reminds me of similar discussions on sharing trial results with participants' families www.liverpool.ac.uk/population-h...

Interesting 👇

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

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...