Mise à jour du livre blanc de la méthodologie ! 👏 👉Ajout d'un document de synthèse sur la méthodologie des groupes contrôles externes ("external control arms") Document en ligne sur le site du livre blanc de la SFPT : sfpt-fr.org/livreblancme... Document PDF : sfpt-fr.org/livreblancme...

How is it that a paper that claims to show how to do target trial emulation does not address confounding by indication and its ramifications for data collection? www.jclinepi.com/article/S089... #EpiSky #StatsSky

Practical elements to consider when emulating a target trial - Journal of Clinical Epidemiology www.jclinepi.com/article/S089...

Brilliantly written with one small caveat: Towards the end the article implies that observational data may be useful for studying heterogeneity in treatment effects. Don't know why that would be the case. But great work Darren! #StatsSky #EpiSky

We should rename these types of funnel plots to ‘avalanche plots’

My own university has a "strategic goal" to increase research "outputs" by 10% annually (7 year doubling time). Your university is almost surely working towards the same. University rankings are now the main driver of this damaging institutional behavior. Publication is an out-of-control arms race.

Too many meta-analyses have findings equivalent to: “If you average the cost of a loaf of bread, car insurance for a year and a movie ticket, you get $752.36”

Do not cite an academic paper unless you’ve read it

We are excited to share a recently published article in Clinical Trials which investigated confirmatory evidence supporting single pivotal trials for new drug approvals. (1/8)

Assessing outcomes emerging after conversion to regular approval for cancer drug indications granted accelerated approval, 1992-2021 url: academic.oup.com/jnci/article...

La dernière étude d'OpenAI prouve mathématiquement que les grands modèles linguistiques produiront toujours des résultats plausibles mais faux (hallucinations), même avec des données parfaites, à cause de la nature statistiques des algorithmes en jeu. www.computerworld.com/article/4059...

Someone was trying to take a portrait of their two fave Chickens, and this happened.

CRISPR is amazing

C'est joli les scores, ça fait des publications, ca donne l'air malin, ca dit que les patients tres malades sont très malades et ont plus de risque de mourir, c'est poussé par des KOL Et quand on les évalue correctement...

www.medrxiv.org/content/10.1... INSPECT-SR: A tool for assessing trustworthiness of randomised controlled trials.

Alzheimer : polémique autour du Leqembi, un médicament à quelques milliards d’euros Par @olivierhertel.bsky.social

If you are analyzing clinical data, you almost certainty don't need a multivariable model unless you are building a prognostic model or asking causal questions. Statistics shouldn't be a performance.

Relevant: (from statsepi.substack.com/p/sorry-what... ICYMI)

I'm not saying you can't generate a hypothesis from data. I'm just saying that generating a hypothesis from the entirety of human knowledge that preceded your data is a much safer bet.

Read our paper in JAMA Internal Med with a great editorial. Wonderful collaboration with @gcabanac.cpesr.fr Retracted papers are included in meta-analyses published in HIF journal. Inclusion of the retracted studies changed effect estimates. jamanetwork.com/journals/jam...

Triangulation of evidence in medical research explained, in work led by Sirena Gutierrez and @mariaglymour.bsky.social Will do a thread when I get a moment link.springer.com/article/10.1...

Provenance and funding of extremely cited biomedical papers published in 2003- 2004, 2013-2014 and 2023-2024

Definitions of Validity Terms for Use in Discussions of Randomized Controlled Trials - Journal of Clinical Epidemiology www.jclinepi.com/article/S089...

Analysis of indications for selectively missing results in comparative registry-based studies in medicine: a meta-research study

Viewpoint: Proposals to lower or eliminate the @fda.gov's preapproval effectiveness requirements for drugs are unnecessary and dangerous, as they undermine patient safety and public health. https://ja.ma/4brnk39

ICYMI: ‘Arbitrary’ Hodgepodge of Composite Endpoints Used Across ASCVD Trials

This is sad...

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.

A more than doubled rate of nirmatrelvir-ritonavir prescriptions was not associated with reductions in hospitalizations or mortality among highly vaccinated older adults in Canada. ja.ma/3ENOh4U #MedSky

"We cannot think that our AI systems will not be biased. There will always be a risk of bias." María Villalobos-Quesada, a researcher at Leiden University Medical Centre, discusses the need for transparent and consistent reporting of quality for #AI tools with JAMA+ AI. #MedSky

Author’s reply : “The importance of properly specifying your target trial emulation: commentary on Mésidor et al.” - Journal of Clinical Epidemiology www.jclinepi.com/article/S089...

Many #researchintegrity sleuths are volunteers with little financial support for their often-daunting work to uncover #scientificfraud. One of the most prominent, Elisabeth Bik, has now provided money to change that. @elisabethbik.bsky.social @science.org www.science.org/content/arti...

**NEW BMJ PAPER** "Uncertainty of risk estimates from clinical prediction models: rationale, challenges, and approaches" - most models provide just a risk estimate - we argue for presenting associated uncertainty too - includes pros, cons, PPIE & methods Hope helpful! www.bmj.com/content/388/...

Short news on the RetoRes website inviting to read the new and insightful @jclinepi.bsky.social paper by @davidit.bsky.social and @jdwilko.bsky.social about trustworthiness checks.

"Common Sense Oncology principles for the design, analysis, and reporting of phase 3 randomised clinical trials"

Interesting 🧐 reading

Using artificial intelligence to semi-automate trustworthiness assessment of randomized controlled trials: A case study - Journal of Clinical Epidemiology www.jclinepi.com/article/S089...

You wait ages and then two arrive at once: reporting guidelines shouldn’t be like buses - Journal of Clinical Epidemiology www.jclinepi.com/article/S089...

Risk of bias assessment tools often addressed items not related to risk of bias and used numerical scores - Journal of Clinical Epidemiology www.jclinepi.com/article/S089...

Uncertainties about the benefit-risk balance of oncology medicines assessed by the European Medicines Agency

Register here to attend the **2nd Contemporary Clinical Trials Methodology Meeting** -a fantastic line-up of speakers in store across 1 or 2 days, including statistical day 1 covering multi-arm multi-stage trials, platform trials & target trial emulation! www.imperial.ac.uk/events/18598...

Dr. Sanjay Kaul giving the Burch Lecture at #AUC2025 discussing Research Misconduct: what is Sloppy Science? Median time from publication to retraction: 1.4 y On average 8 citations before retraction Don’t be a John Darsee! The DECREASE 1 trial: BB use entered guidelines despite 2 day retraction

Nouvelle entrée sur le blog de la méthodologie : Essai de non-infériorité : choix du seuil de non-infériorité et expression en différence de risques ou en rapport de risques sfpt-fr.org/blog-des-art...

Centers for Medicare & Medicaid Services coding changes linking abdominal wall hernia size to reimbursement were associated with an increase in documented hernia size by surgeons. ja.ma/42gdA96

We've frustratingly allowed "real world" to become a deceptive synonym for "observations we happened haphazardly to make". I'd say half the studies that come to me now, the majority of which are useful but modest clinical audits, will have "real world" in the proposal title. It's magic!

Let's stop encouraging novice researchers to think that lots of "data cleaning" is normal, or even a good thing. Why are we so proud of all this data cleaning!? The need for lots of data cleaning should instead be seen as a failure to invest in data collection. In medicine, this harms patients.

Glad to learn of this, & to see it refer to the classic Cook & Farewell paper on multiplicity in #ClinicalTrials. People need to know that corrections are sometimes appropriate for testing a union (H1 OR H2) but not for testing H1 just because you test H2 a minute later. #StatsSky #rct #Statistics

FDA Issues Draft Guidance for Accelerated Approval Confirmatory Clinical Trials @fda.gov #oncology #MedEd www.onclive.com/view/fda-iss...

Our work on immortal time bias "Illustrating the structures of bias from immortal time using directed acyclic graphs" led by Emma Guoyi Yang @yanggy_hku is out at International Journal of Epidemiology: doi.org/10.1093/ije/.... Brief thread:

1/ That "immortal time" is so frequent in survival analyses for #causalinference is fascinating. Because "immortal time" doesn't exist in the data, *we* create it when misanalyzing the data. Our new paper pubmed.ncbi.nlm.nih.gov/39494894/ summarizes why immortal time arises & how to prevent it.