I wish I didn't have a meeting conflict or I would have liked to attend this rare disease workshop. I do hope that study designers will realize that sequential Bayesian two-arm RCTs are better solutions in many cases: hbiostat.org/bayes/design #Statistics #StatsSky #clinicaltrial

Single arm, RCT or something in between – how to enrich clinical trial design and analysis in rare diseases Tomorrow 3 Feb at 4 pm UK time realised-ihi.eu/do-you-want-...

EMA's Concept Paper for the Development of a Reflection Paper on the use of Bayesian methods in clinical development (PDF) www.ema.europa.eu/en/documents...

Editorial: The best management for most patients with incurable cancer is on a clinical trial www.annalsofoncology.org/article/S092...

EFSPI is hosting webinars on “Statistical Considerations in Oncology Study Designs”, in February 2026, by the Finnish, German and Italian EFSPI member groups. Check: www.linkedin.com/posts/efspi_...

Among adolescents and young adults with #cancer, 9.5% of patients with earlier-stage cancer experienced metastatic recurrence within five years, with the highest rates in sarcoma (24.5%) and colorectal cancer (21.8%). ja.ma/4t4zYNZ

International Consensus-Driven Recommendations for Patient-Reported Outcome Research Objectives in Early Phase Dose-Finding Oncology Trials: OPTIMISE-ROR ascopubs.org/doi/10.1200/...

Inverse Probability of Treatment Weighting: A Simple and Effective Approach to Covariate Adjustment for Survival Endpoints in Randomized Clinical Trials www.tandfonline.com/doi/full/10....

Citation Millionaire: Doug Altman by @gscollins.bsky.social and Jonathan J Deeks www.bmj.com/content/391/...

All Biostatistics guidelines from the EMA: www.ema.europa.eu/en/human-reg...

Nature retracts paper for data manipulation by Ph.D. student retractionwatch.com/2026/01/14/n...

'How to interpret hazard ratios', with @dominicmagirr.bsky.social and @timpmorris.bsky.social thestatsgeek.com/2026/01/15/h...

Covariate adjustment in trials with survival endpoints using RobinCar2 www.rconis.com/blog/robinca...

Comments on FDA's draft guidance on the use of Bayesian methodology in trials: www.linkedin.com/pulse/reflec...

The 100 most influential CEOs in oncology (2025) oncodaily.com/100/100-most...

New US FDA Draft Guidance: Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products www.fda.gov/regulatory-i...

ISBS Webinar: Is Repeated Bayesian Interim Analysis Consequence-Free? Speaker: Ying Yuan, to discuss his work with FDA here: arxiv.org/abs/2508.07403 us06web.zoom.us/meeting/regi... 30 Jan, 4 PM London

New book! Estimands in Clinical Trials: A Practical Guide (Springer) link.springer.com/book/10.1007...

Webinar: Philip He (Early phase statistics, Daiichi Sankyo) will talk about: Ensuring Quality and Interpretability of PFS and OS in Oncology Clinical Trials 🗓 Date & Time: Friday, Jan 16th, 2026 08:00 – 09:00 AM (PDT) Zoom link in this post: www.linkedin.com/posts/yi-pan...

"40 percent of MRI signals do not correspond to actual brain activity"; "Since tens of thousands of fMRI studies worldwide are based on this assumption, our results could lead to opposite interpretations in many of them.” www.tum.de/en/news-and-...

UK ECMC network's 99 gene panel recommendations www.nature.com/articles/s41...

Eleven clinical trials that will shape medicine in 2026 rdcu.be/eWeT4

Robust Modestly Weighted Log-Rank Tests onlinelibrary.wiley.com/doi/10.1002/...

Authors here estimate of DOR with IPCW, using JAVELIN Renal-101 trial data, and inference with resampling methods. This would account for competing/intercurrent events. They also provide code here: lmaowisc.github.io/dor/ evidence.nejm.org/doi/10.1056/...

Why are 3+3 phase 1 designs still being used? Frustrating

Our guidance regarding performance measures for medical AI models is finally out! - Stop bashing AUROC, although it does not settle things - Calibration and clinical utility are key - Show risk distributions - Classification statistics (e.g. F1) are improper www.thelancet.com/journals/lan...

Comments on ICH E20 draft guidance from all the leading UK experts on adaptive trial methodology! Here www.regulations.gov/comment/FDA-... and www.regulations.gov/comment/FDA-...

Update in R: "x %notin% table newly in base is an idiom for !(x %in% table) and provided almost entirely for convenience and code readability..." stat.ethz.ch/R-manual/R-d...

More on single arm trials (stop me if you think you've heard this one before). I'd actually really like someone to argue against what I'm saying here. There are loads of trials like this one, which seems problematic. simonelgato.github.io/2025/12/06/n...

TiTE-STEIN www.tandfonline.com/doi/full/10....

Version 2.0 of crmPack www.rconis.com/blog/crmPack...

New paper in @jclinepi.bsky.social: **Estimands: what they are and why we should use them** We provide simple explanations of: -estimands and intercurrent events -how these relate to familliar concepts like ITT -how to write estimands for protocols -and more www.jclinepi.com/article/S089...

For those who complained about the recent RCT on PSA not looking at overall mortality, note that Gil Welch, the well-respected screening skeptic, concluded "It is not feasible to test all-cause mortality when screening for an individual cancer" pubmed.ncbi.nlm.nih.gov/37639251/

Stakeholder Perspectives on Randomized Clinical Trials for Children With Poor-Prognosis Cancers jamanetwork.com/journals/jam...

Why does every target trial emulation study have to include a bit that says "this shows how great target trial emulation is. RCTs are non-generalisable and expensive"? Imagine if every RCT said "this shows how great RCTs are. We did not have to rely on strong, untestable assumptions".

"... your columnist is a statistical totalitarian, who holds the radical view that statistical method should be applied to everything, even statistics." How to rescale examination marks (with added bonus of free Excel sheet). senns.uk/wprose.html#...

HYBRID EVENT: 'Introduction to Quantitative Bias' with Rachel Hughes on Monday 1st December at 10am-12pm UK time. For those near Leeds, bring your laptop and enjoy this as an in-person session! Sign-up before 9am on Thursday 27th via: www.eventbrite.co.uk/e/introducti...

NIHR Statistics: A two-part webinar series on Practical Approaches to Dose Optimisation in Oncology Trials. www.linkedin.com/posts/pavel-...

Next, NASA: The claim "Russell's china teapot orbiting the sun between Earth and Mars" is not an evidence-based claim bec studies have not ruled out the existence of such a teapot. 😆

I didn't know about this: Guidance for Industry and FDA Staff Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests (2007) www.fda.gov/media/71147/...

There seems to be Cloudfare disruption leading to limited access to Wiley/Elsevier...

Using inverse probability of censoring weighting to estimate hypothetical estimands in clinical trials: Should we implement stabilisation, and if so how? journals.sagepub.com/doi/10.1177/...

I don’t like ‘undershot’ as a criterion. I want non-coverage in each tail to be very close to alpha/2. And Wilson works fine for large n so not need to be switching. R’s Hmisc::binconf is an old function that computes Wilson’s interval. Also there is no excuse for continuing use of symmetric CIs

Perhaps this is why so much microbiome research is hard to believe. www.gov.uk/government/n...

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...