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Clinical trials methodology; statistician; health researcher; tea drinker; scowly headache; commuter; UCL professor; MRC CTU at UCL; BHF DSC at HDR UK; Health Data Research UK; Trials Methodology Research Partnership; Electronic Health Records; Healthcare systems data for trials; Data sharing; Data Monitoring Committees; Academic clinical trials; credit and recognition; better trials = better health outcomes
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I hope my set of #RedemptionWeek threads on #ClinicalTrials and #Methodology has been in some way useful to a couple of people. It’s certainly been cathartic for me.

6/6

There are other good examples in the literature, including that from ISIS-2 which tongue-in-cheek-ly uses the spoon-bendy nonsense of astrology as it's jumping off point. We went more mundane.

5/6

I raise this paper here in hope people will use this, if they aren’t already, for #Teaching on their MSc in Clinical Trials courses , such as that run by UCL's Institute of Clinical Trials and Methodology (https://www.ucl.ac.uk/prospective-students/graduate/taught-degrees/clinical-trials-msc)

4/6

Clinical Trials MSc

Prospective Students Graduate

A key lesson is to specify upfront both the planned analysis and the expected direction of effect. Anything else should be noted as “exploratory”.
The full version of Figure 1 is worth exploring (abridged version here).

3/6

Using real #ClinicalTrial data, our example allows readers to think about the plausibility of subgroup analyses.
This was solicited by Annals of Oncology (via Gert Attard) after Nick James presented at ASCO 2017. Mel Spears was 1st author.

2/6

A bonus following my #RedemptionWeek:
I’m highlighting a short paper that can be used for teaching caution in #ClinicalTrial subgroups:
“‘Thursday’s child has far to go’—interpreting subgroups and the #STAMPEDEtrialhttps://www.annalsofoncology.org/article/S0923-7534(19)34965-8/fulltext

1/6

I’ll be back to wrap up my (rather stretched out) #Methodology #ClinicalTrials #RedemptionWeek

11/11

Watch out for forthcoming findings from DEDICATE, PRIMORANT and COMORANT and DUCkS.

Come talk to us at HDRUK, TMRP Health Informatics WG, BHF Data Science Centre, and MRC CTU at UCL. 🎩👒 🎓 🥳

10/11

Here’s a keynote presentation from Sep-2022 in Glasgow on the topic https://youtu.be/K-935vUcZcI?t=584

(Day after the Queen died so might feel like an odd start)

9/11

Glasgow Clinical Trials Forum 2022

YouTube

There’s a lot of work to be done to put in place the capacity, the capabilities and the desire. We need to resolve: Integrity/Provenance; Utility; Access; Retention; and we need to increase capabilities.

We can do this!

8/11