Did you know the FDA has gone full Bayesian?

Better take in this blogpost, including intro to the context of guidance documents

The guidance is quite good, but as stated in the blogpost, it leaves out where the FDA finds Bayesian methods acceptable.

statmodeling.stat.columbia.edu/2026/01/15/f...

In other #regulatory news: FDA has released their draft guidance on #Bayesian Methods for public consultation.

This guidance has been under development for quite some time and is a good overview about the regulatory thinking / interpretation of Bayesian methods.

www.fda.gov/media/190505...

In joint work with #EMA and #FDA colleagues we wrote down 10 guiding principles of good #AI practices in #drugdevelopment that are now finally published 🎉

They are quite general and hopefully universally agreed upon, detailed guidance will follow.

www.fda.gov/media/189581...

#pharma #regulatory

Should statistical software that estimates causal effects also tell you the causal assumptions under which that estimate can be interpreted as causal?

I don't know but my PhD student Maurice Korf has some thoughts (and software) to get the conversation going:

academic.oup.com/ije/article/...

The distinction between causal, predictive, and descriptive research—there is still room for improvement - Journal of Clinical Epidemiology www.jclinepi.com/article/S089...

Great experience with a novel format of an invited session of #stratos TG2 @biometricsociety.bsky.social Austro-Swiss region meeting (ROeS 2025 Graz) (1/n)

doi.org/10.1002/sim....

Our paper "A Comparison of Statistical Methods for Time-To-Event Analyses in Randomized Controlled Trials Under Non-Proportional Hazards" got published today 🎉

We describe commonly used methods, and compare their performance in a simulation study across different scenarios.

An LLM "creates textual claims, and then predicts the citations that might be associated with similar text. Obviously, this practice violates all norms of scholarly citation.

At best, LLMs gesticulate toward the shoulders of giants."

Bender, West, and I contributed to this pro/con piece in PNAS.

Paper finally acxepted after 3 years of work on the project with a large consortium 🎉

I'll post a link, when it's published

Hallo, Bluesky! Wir sind neu hier und freuen uns, Teil dieser Community zu werden! Freut euch auf spannende Inhalte rund um die Gesundheit von Mensch, Tier, Pflanze und Umwelt. Sagt "Hi" in den Kommentaren und folgt uns für mehr! 💛 www.ages.at

I have the greatest respect for graphics in scientific papers before computer graphics and even pen plotters were a common thing. Just beautiful 😍

Hi bluesky 👋

Hope there's some biostats people here, all the R people are also on mastodon but biostats wise it's been a bit lonely since leaving twitter

Key question to consider before submitting your paper on the development and validation of your new clinical prediction model is:

WHERE IS THE MODEL????