Could all clinical trial results be monitored in a dashboard like this? We hope so: Decisions on efficacy and futility can be taken as soon as possible. Collaboration is made straightforward. Small studies can easily contribute and might be less often file-drawered. And for decisions of (funding) new research, a live account of the evidence might improve the assessment of research that needs extra trials.
We call it ALL-IN meta-analysis: Anytime, Live and Leading INterim meta-analysis.
Yet for such live monitoring of interim trial results, new statistical methodology had to be developed. This is what we did since the start of the corona pandemic. We went 'all-in' on developing methods for clinical trials with time-to-event data (also known as: survival data).
Ideas for live monitoring of randomized trials were in the works for ten years (e.g. already in Prof. Peter Grünwald's inaugural lecture in 2009). And for me, three years of (parttime) PhD research were exactly enough to know that we could develop this for COVID19 clinical trials. So in an amazing effort, we went from initial mathematic ideas, to software, to simulations, to tutorials, to mathematical proofs, to a paper that is soon to appear. I'm very grateful to dr. Alexander Ly for working so hard with me on this, and to Muriel Pérez for joining the mathematical effort.
And as the proof of the pudding: a wonderful collaboration with the Utrecht and Nijmegen medical hospitals UMC Utrecht (Prof. Marc Bonten) and Radboud UMC (Prof. Mihai Netea), on trials studying the BCG vaccine as a general immune system booster. I want to specifically acknowledge dr. Henri van Werkhoven, the trial statistician of the Utrecht/Nijmegen trials on the BCG vaccine, for his confidence and nerve amid the chaos of the initial months of the pandemic. The many conversations I had with him really fine-tuned the ALL-IN approach and its presentation. He is now the Principal Investigator of ALL-IN-META-BCG-CORONA, of which I am the meta trial statistician.
You can have a look at a demo version of our dashboard at https://cwi-machinelearning.shinyapps.io/ALL-IN-META-BCG-CORONA/
User name: demo
Detailed materials of ALL-IN-META-BCG-CORONA can be found on https://projects.cwi.nl/safestats/. A preprint paper and more links to blogposts will appear soon.
Mon, 06 July