New EMA draft guidance on non-inferiority and equivalence trials www.ema.europa.eu/en/non-infer...

Webinar on Innovative trial designs for rare diseases, with great speakers! 9 December, 2:00 PM - 3:00 PM GMT events.teams.microsoft.com/event/a90f5f...

"[Models] may be engineered to reduce bias more readily than human reviewers can control and disclose their own biases" Citation needed? jamanetwork.com/journals/jam...

LLMs are net negative to humanity www.nature.com/articles/d41...

"Cosgrove added that while the new placebo primary care physicians have generally been found to correspond with positive outcomes, the AMA had yet to achieve an equivalent success rate among its pilot group of placebo surgeons."

"...statistical statements are not wrong _because_ they are uncertain, they are wrong if claimed to be more certain (or less certain) than they are." Stephen Senn errorstatistics.com/2020/01/20/s...

Not me creating an account on X just to re-read all Frank Harrell vs Judea Pearl tweets. 😅

This seed produces 30 successes in a row! 🤯 h/t Andi Fugard @andifugard.info www.linkedin.com/posts/andifu... #rstats

SAS laid off its China-based employees (400 of them!) and its Chinese website taken offline www.scmp.com/tech/tech-tr...

I'm increasingly proud to have written and published things before LLMs existed.

Hierarchy of causal inference for treatment efficacy via @f2harrell.bsky.social

A very cool intro to measuring agreement onlinelibrary.wiley.com/doi/10.1002/...

Supporting the professional development of trial managers: how can you help? link.springer.com/article/10.1...

ISBS Webinar Series is hosting Dr. Carl-Fredrik Burman from stats innovation in AstraZeneca to discuss: “Bayesian Borrowing: Some Philosophical Thoughts on Statistical Inference” Time: Nov 7, 2025 11am-12pm EDT (4-5pm London) Abstract and Zoom Link: www.linkedin.com/posts/cindy-...

The MedxR package allows users to retrieve real-time or historical information about drug approvals, adverse events, product recalls, and pharmaceutical details lightbluetitan.github.io/medxr/

DEBATE: "Is AI the future of health and social science?" For those in London on 15 Dec 2025, don't miss this fun in person debate between me and David Bann sponsored by @ncrm.ac.uk! Will the arguments change anyone's mind? 🤔 Sign up to attend IN PERSON: www.eventbrite.co.uk/e/is-ai-the-...

An interactive session by Cytel to discuss any of the FDA Oncology guidances! October 29th, 2pm London cytel.com/news-and-eve...

Low participation in medical trials puts millions of young people at risk Wendy Macdowall tells The Guardian about underrepresented groups in #research & need to understand how experiences of interventions differ #PublicHealth www.theguardian.com/society/2025...

University of California affiliated scholars took home five awards across medicine, physics, and chemistry in a single month www.universityofcalifornia.edu/press-room/u....

The agenda for @rinpharma.bsky.social 2025 conference is pretty cool events.zoom.us/ev/Ai-geyS63...

nQuery's webinar on ICH E20. October 23 www.statsols.com/guides/impac...

FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Dosages for First-In-Human Trials aacrjournals.org/clincancerre...

Group-sequential designs: Interim analysis, primary analysis, confirmatory analysis, updated analysis, and decisive analysis... trialsjournal.biomedcentral.com/articles/10....

Only ~1-2% of published trials that use the Simon's two-stage design reported an adjusted inference. And looks like <1% actually do the stage 2 test at all. Isn't this so disappointing given that it is so easy to do? Peer reviewers, funders? From 2021: ascopubs.org/doi/10.1200/...

MD Anderson Cancer Center has an institutional policy that phase 2 trials using treatments with limited prior safety data must have formal toxicity monitoring. Bayesian sequential monitoring is simple to design and ensures patient safety. It should be mandatory for all early-phase trials worldwide.

“Skepticism is the highest duty and blind faith the one unpardonable sin.” — Thomas Henry Huxley, Essays on Controversial Questions (1889)

Last year, I had a paper rejected after 18 months with the @amjepi.bsky.social. It's the first time I've had a paper rejected after being invited for revisions. And the first time I've had a paper sent out to completely new reviewers. It stung so hard that it's taken me a year to look at again.

A lot of "beliefs" don't make sense to me once I put 95% confidence or credible intervals around its estimates..

Just out: the new IARC Evidence Summary Brief on alcohol and cancer 📰🍷 Proud to have contributed to this important work highlighting the global burden, economic impact, and the urgent need for policy action. Check it out here 👉 www.iarc.who.int/featured-new...

Handling Missingness, Failures, and Non-Convergence in Simulation Studies: A Review of Current Practices and Recommendations @amstatnews.bsky.social #openaccess www.tandfonline.com/doi/full/10....

UK clinical trial approval times twice as fast with AI and reforms www.gov.uk/government/n...

This year’s Nobel Prize in Physiology or Medicine has been awarded to three scientists for discovering a class of immune cells that help to prevent the body from attacking its own tissues go.nature.com/48QDdAJ

RIP Jane Goodall, a truly inspirational human.

FDA Project Optimus guidance specifically states that it doesn't address radiopharmaceuticals. They have now posted a draft guidance for dose optimization for those agents here: www.fda.gov/regulatory-i...

Free webinar series on simulation guided trial design using FACTS www.berryconsultants.com/resource/fac...

Looks like BOIN is already replacing 3+3 designs ascopubs.org/doi/10.1200/...

RIP John Searle en.wikipedia.org/wiki/John_Se...

Paracetamol use during pregnancy does not increase risk of autism Laurie Tomlinson explains best available evidence shows #paracetamol safe to take during pregnancy & urges parents to seek reputable sources of information, & medical advice from GP. www.lshtm.ac.uk/newsevents/n...

The Americas, Western Pacific, and Europe together hosted almost 90% of oncology trials worldwide. USA alone accounted for nearly 1/3rd... www.nature.com/articles/s41...

The C-index Multiverse arxiv.org/abs/2508.14821

CRAN's Task View for Clinical Trial Design, Monitoring, and Analysis has been updated in September 2025! cran.r-project.org/web/views/Cl... @thomasjaki.bsky.social

UK clinical trials are under pressure www.bmj.com/content/390/...

FDA's draft guidance on the assessment of overall survival in oncology trials www.fda.gov/regulatory-i...

I seem to have been discussing pilot and feasibility studies a lot this week. One question often asked is how big should my pilot/feasibility study be? 1/6 #MethodologyMonday #124

Are estimands being correctly used? A new review of protocols led by Timothy Clark shows many incorrectly defined estimand attributes. See the top areas for improvement & full results here: trialsjournal.biomedcentral.com/articles/10.... #Trials

We are excited to launch our new Research Methods Academy: Seminar Series! Hear from leading experts on innovative and best practice methods to strengthen your research proposal. Find out more and register: www.nihr.ac.uk/news/nihr-la...

I think we need more studies like this, investigating OS surrogates in different malignancies: www.sciencedirect.com/science/arti...

Great resource 👇

Prof @vcornelius.bsky.social @imperialctu.bsky.social @statsci.bsky.social inaugural lecture (in-person in Imperial & online)! 30 October 2025 "Under pressure: smarter trials for better health outcomes" www.imperial.ac.uk/events/19688...