Eslam Maher
@eslammaher.bsky.social
📤 48
📥 144
📝 95
Oncology trials and biostatistics
https://scholar.google.co.uk/citations?user=ZbSK3WwAAAAJ
reposted by
Eslam Maher
Frank Harrell
7 days ago
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
loading . . .
Bayesian Design
https://hbiostat.org/bayes/design
2
2
1
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-...
loading . . .
Do You Want to Stay Single? Considerations on Single-Arm Trials in Drug Development - Realise D
This webinar from RealiseD shows how to enrich clinical trial design and analysis in rare diseases. Single arm, RCT or something in between?
https://realised-ihi.eu/do-you-want-to-stay-single-considerations-on-single-arm-trials-in-drug-development/#
7 days ago
1
5
2
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...
loading . . .
https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-reflection-paper-use-bayesian-methods-clinical-development_en.pdf
9 days ago
0
0
0
Editorial: The best management for most patients with incurable cancer is on a clinical trial
www.annalsofoncology.org/article/S092...
loading . . .
The best management for most patients with incurable cancer is on a clinical trial
Cancer clinical trials are the foundation for medical advances in oncology.1,2 Despite ongoing skepticism about their direct benefits to participants, we argue that the best management for most patien...
https://www.annalsofoncology.org/article/S0923-7534(24)04913-5/abstract
13 days ago
0
0
0
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_...
loading . . .
EFSPI - Flayer Onco Webinars | EFSPI (European Federation of Statisticians in the Pharmaceutical Industry)
📢 Upcoming EFSPI Webinar Series – Registration Now Open! The EFSPI Scientific and Training Academy is pleased to announce a new webinar mini-series on “Statistical Considerations in Oncology Study De...
https://www.linkedin.com/posts/efspi_efspi-flayer-onco-webinars-activity-7421545270879875072-sB8n?utm_source=share&utm_medium=member_desktop&rcm=ACoAAB6Tbb0BG91X2osX1uS7Qn-iBHSp7qUlfqk
14 days ago
0
0
0
reposted by
Eslam Maher
JAMA Oncology
16 days ago
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
0
2
1
International Consensus-Driven Recommendations for Patient-Reported Outcome Research Objectives in Early Phase Dose-Finding Oncology Trials: OPTIMISE-ROR
ascopubs.org/doi/10.1200/...
loading . . .
International Consensus-Driven Recommendations for Patient-Reported Outcome Research Objectives in Early Phase Dose-Finding Oncology Trials: OPTIMISE-ROR
PURPOSEThere is growing scientific interest in incorporating patient-reported outcomes (PROs) in early phase dose-finding oncology trials (DFOTs) to assess tolerability, inform dose selection, and gui...
https://ascopubs.org/doi/10.1200/JCO-25-01625
16 days ago
0
0
0
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....
loading . . .
Inverse Probability of Treatment Weighting: A Simple and Effective Approach to Covariate Adjustment for Survival Endpoints in Randomized Clinical Trials
Covariate adjustment aims to improve the statistical efficiency of randomized trials by incorporating information from baseline covariates. Popular methods for covariate adjustment include analysis...
https://www.tandfonline.com/doi/full/10.1080/19466315.2026.2615999
16 days ago
0
0
0
Citation Millionaire: Doug Altman by
@gscollins.bsky.social
and Jonathan J Deeks
www.bmj.com/content/391/...
loading . . .
The making of a statistician: Doug Altman
Doug Altman was an internationally renowned statistician who served as The BMJ ’s chief statistical adviser. He was also our boss, mentor, and friend for over 26 years, until his early death in 2018.1...
https://www.bmj.com/content/391/bmj.r2616
18 days ago
0
0
0
All Biostatistics guidelines from the EMA:
www.ema.europa.eu/en/human-reg...
loading . . .
Biostatistics | European Medicines Agency (EMA)
https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-guidelines/clinical-efficacy-safety-guidelines/biostatistics
19 days ago
0
0
0
Nature retracts paper for data manipulation by Ph.D. student
retractionwatch.com/2026/01/14/n...
loading . . .
Nature retracts paper for data manipulation by Ph.D. student
Nature has retracted a paper after an investigation at a U.K. institution found the first author — then a doctoral student — manipulated data. The paper, which looked at the sensitivity of lu…
https://retractionwatch.com/2026/01/14/nature-retraction-francis-crick-institute-data-manipulation-phd-student/
25 days ago
0
1
0
reposted by
Eslam Maher
Jonathan Bartlett
25 days ago
'How to interpret hazard ratios', with
@dominicmagirr.bsky.social
and
@timpmorris.bsky.social
thestatsgeek.com/2026/01/15/h...
loading . . .
How to interpret hazard ratios
Survival analysis of time-to-event outcomes is very commonly performed using Cox’s famous proportional hazards model. The model estimates hazard ratios for the ‘effects’ of covari…
https://thestatsgeek.com/2026/01/15/how-to-interpret-hazard-ratios/
1
21
9
Covariate adjustment in trials with survival endpoints using RobinCar2
www.rconis.com/blog/robinca...
loading . . .
RobinCar2: Reliable Covariate Adjustment Package – RCONIS
Research Consulting and Innovative Solutions.
https://www.rconis.com/blog/robincar2-release/
25 days ago
0
0
0
Comments on FDA's draft guidance on the use of Bayesian methodology in trials:
www.linkedin.com/pulse/reflec...
loading . . .
Reflections on the FDA Draft Guidance (Jan 2026): Understanding Bayesian Operating Characteristics and Inferential Roles
Sharing some personal reflections after carefully reading the FDA’s January 2026 draft guidance on Bayesian methodology in clinical trials, particularly the discussion on operating characteristics. Wh...
https://www.linkedin.com/pulse/reflections-fda-draft-guidance-jan-2026-understanding-haitao-pan-qwjcc/
25 days ago
0
0
0
The 100 most influential CEOs in oncology (2025)
oncodaily.com/100/100-most...
loading . . .
The 100 Most Influential CEOs in Oncology in 2025 (Full List) - OncoDaily
The 100 Most Influential CEOs in Oncology in 2025 (Full List) / 100 Most Influential CEOs, Adam Garone, Albert Bourla, Alessandro Jacques Cortese, Alicia
https://oncodaily.com/100/100-most-influential-ceos-438440
30 days ago
0
0
0
New US FDA Draft Guidance: Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products
www.fda.gov/regulatory-i...
loading . . .
Use of Bayesian Methodology in Clinical Trials of Drug and Biological
This draft guidance provides guidance to sponsors and applicants on the appropriate use of Bayesian methods in clinical trials.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-bayesian-methodology-clinical-trials-drug-and-biological-products
about 1 month ago
0
0
0
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
loading . . .
Welcome! You are invited to join a meeting: ISBS Webinar - Is Repeated Bayesian Interim Analysis Consequence-Free?. After registering, you will receive a confirmation email about joining the meeting.
Dear Fellow Statisticians, We are pleased to announce an exciting upcoming seminar as part of the ISBS Webinar Series on clinical trial innovation. The seminar, titled " Is Repeated Bayesian Interim A...
https://us06web.zoom.us/meeting/register/R_Z30Az8QNi2XBUxItrOdw#/registration
about 1 month ago
1
0
0
New book! Estimands in Clinical Trials: A Practical Guide (Springer)
link.springer.com/book/10.1007...
loading . . .
Estimands in Clinical Trials
This book gives guidance on implementing the estimand framework in diverse trial settings and explores real-world case studies.
https://link.springer.com/book/10.1007/978-3-032-02192-2
about 1 month ago
0
0
0
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...
loading . . .
#dahshu #idswg #kolseminar #oncologyclinicaltrials #clinicaltrialdesign #progressionfreesurvival #overallsurvival #estimands #iche9r1 #oncologystatistics #biostatistics #regulatoryscience… | Yi Pan
✨ Jan 2026 DahShu IDSWG KOL Seminar ✨ We are honored to welcome Dr. Philip He as our distinguished speaker! 📘 Title: Ensuring Quality and Interpretability of Progression Free Survival and Overall ...
https://www.linkedin.com/posts/yi-pan-8a695815_dahshu-idswg-kolseminar-activity-7409225560746475521-zZlN/
about 1 month ago
0
0
0
reposted by
Eslam Maher
Magnus Johansson
about 1 month ago
"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-...
loading . . .
40 percent of MRI signals misinterpreted
Interpretation of numerous MRI data may be incorrect: blood flow is not a reliable indicator of brain activity.
https://www.tum.de/en/news-and-events/all-news/press-releases/details/40-percent-of-mri-signals-do-not-correspond-to-actual-brain-activity
5
170
95
UK ECMC network's 99 gene panel recommendations
www.nature.com/articles/s41...
loading . . .
Experimental Cancer Medicine Centre (ECMC) network proposal for a consensus gene panel for pan-cancer sequencing: a Delphi methodology - British Journal of Cancer
British Journal of Cancer - Experimental Cancer Medicine Centre (ECMC) network proposal for a consensus gene panel for pan-cancer sequencing: a Delphi methodology
https://www.nature.com/articles/s41416-025-03252-6
about 1 month ago
0
0
0
Eleven clinical trials that will shape medicine in 2026
rdcu.be/eWeT4
loading . . .
Eleven clinical trials that will shape medicine in 2026
Nature Medicine - Nature Medicine asks leading researchers to name their top clinical trial for 2026, from long-awaited vaccines for infectious diseases to new treatments for advanced cancers and...
https://rdcu.be/eWeT4
about 2 months ago
0
1
0
Robust Modestly Weighted Log-Rank Tests
onlinelibrary.wiley.com/doi/10.1002/...
loading . . .
Robust Modestly Weighted Log‐Rank Tests
The introduction of checkpoint inhibitors in immuno-oncology has raised questions about the suitability of the log-rank test as the default primary analysis method in confirmatory studies, particular...
https://onlinelibrary.wiley.com/doi/10.1002/pst.70066
about 2 months ago
0
0
0
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/...
loading . . .
Evaluating Treatment Effects with Patient-Response–Related Outcomes in Comparative Clinical Trials
In comparative clinical investigations for nearly all disease types, patient responses — signifying clinically meaningful improvements in health or reductions in disease burden — are routinely empl...
https://evidence.nejm.org/doi/10.1056/EVIDctw2400349
about 2 months ago
0
0
0
Why are 3+3 phase 1 designs still being used? Frustrating
about 2 months ago
0
0
0
reposted by
Eslam Maher
Ben Van Calster
about 2 months ago
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...
loading . . .
Evaluation of performance measures in predictive artificial intelligence models to support medical decisions: overview and guidance
Numerous measures have been proposed to illustrate the performance of predictive artificial intelligence (AI) models. Selecting appropriate performance measures is essential for predictive AI models i...
https://www.thelancet.com/journals/landig/article/PIIS2589-7500(25)00098-6/fulltext
2
48
26
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-...
loading . . .
Regulations.gov
https://www.regulations.gov/comment/FDA-2025-D-3023-0009
2 months ago
0
0
0
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...
loading . . .
R: R News
https://stat.ethz.ch/R-manual/R-devel/doc/html/NEWS.html
2 months ago
0
0
0
reposted by
Eslam Maher
Simon Gates
2 months ago
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...
loading . . .
Single arm neuroblastoma trial
This post is about this trial: Furman et al. A Phase II Trial of Hu14.18K322A in Combination with Induction Chemotherapy in Children with Newly Diagnosed High-Risk Neuroblastoma. Clin Cancer Res (2019...
https://simonelgato.github.io/2025/12/06/neuroblastoma-single-arm.html
2
3
2
TiTE-STEIN
www.tandfonline.com/doi/full/10....
loading . . .
TITE-STEIN: Time-to-event simple toxicity and efficacy interval design to accelerate phase I/II trials
Oncology dose-finding trials are shifting from identifying the maximum-tolerated dose (MTD) to determining the optimal biological dose (OBD), driven by the need for efficient methods that consider ...
https://www.tandfonline.com/doi/full/10.1080/10543406.2025.2592615
2 months ago
0
1
0
Version 2.0 of crmPack
www.rconis.com/blog/crmPack...
loading . . .
crmPack 2.0: A Major Milestone for Adaptive Dose Escalation Trials – RCONIS
Research Consulting and Innovative Solutions.
https://www.rconis.com/blog/crmPack-release/
2 months ago
0
1
0
reposted by
Eslam Maher
Brennan Kahan
2 months ago
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...
loading . . .
Estimands: what they are and why we should use them
In clinical trials, postrandomization events, such as treatment discontinuation or the use of rescue medication, can complicate the interpretation of results. An estimand is a precise description of t...
https://www.jclinepi.com/article/S0895-4356(25)00387-7/fulltext
0
11
5
reposted by
Eslam Maher
Andrew Vickers
2 months ago
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/
loading . . .
Testing Whether Cancer Screening Saves Lives: Implications for Randomized Clinical Trials of Multicancer Screening - PubMed
It is not feasible to test all-cause mortality when screening for an individual cancer. However, it is feasible to test all-cause mortality for multicancer screening because cancer deaths are such a large component of deaths in general. Observational data on the effects of cancer screening are misle …
https://pubmed.ncbi.nlm.nih.gov/37639251/
0
2
1
Stakeholder Perspectives on Randomized Clinical Trials for Children With Poor-Prognosis Cancers
jamanetwork.com/journals/jam...
loading . . .
Randomized Clinical Trials for Children With Poor-Prognosis Cancers
This special communication reports multistakeholder consensus recommendations regarding randomized clinical trials of new therapies for children with poor-prognosis cancers.
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2827560
2 months ago
0
1
0
reposted by
Eslam Maher
Jack Wilkinson
2 months ago
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".
6
52
14
reposted by
Eslam Maher
Stephen Senn
3 months ago
"... 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#...
loading . . .
Guernsey McPearson Prose
Continuitis, Dichotomania and the Tetrachoric Coefficient of Correlation
https://senns.uk/wprose.html#Mote
1
3
1
reposted by
Eslam Maher
Peter Tennant
3 months ago
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...
1
15
15
NIHR Statistics: A two-part webinar series on Practical Approaches to Dose Optimisation in Oncology Trials.
www.linkedin.com/posts/pavel-...
loading . . .
Webinar information | Pavel Mozgunov
Webinars on Dose Optimisation: Industry and Regulatory Perspectives! Join us for a two-part webinar series on Practical Approaches to Dose Optimisation in Oncology Trials. This series will bring toge...
https://www.linkedin.com/posts/pavel-mozgunov_webinar-information-activity-7397298494643945473-cEUW?utm_source=share&utm_medium=member_desktop&rcm=ACoAAB6Tbb0BG91X2osX1uS7Qn-iBHSp7qUlfqk
3 months ago
0
0
0
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. 😆
add a skeleton here at some point
3 months ago
0
0
0
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/...
loading . . .
https://www.fda.gov/media/71147/download
3 months ago
0
0
0
There seems to be Cloudfare disruption leading to limited access to Wiley/Elsevier...
3 months ago
0
0
0
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/...
loading . . .
Sage Journals: Discover world-class research
Subscription and open access journals from Sage, the world's leading independent academic publisher.
https://journals.sagepub.com/doi/10.1177/09622802251387456
3 months ago
0
0
0
reposted by
Eslam Maher
Frank Harrell
3 months ago
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
0
1
1
reposted by
Eslam Maher
David Colquhoun
3 months ago
Perhaps this is why so much microbiome research is hard to believe.
www.gov.uk/government/n...
loading . . .
MHRA-led study reveals major inconsistencies in global microbiome research
International collaboration establishes new quality standards to improve reliability of gut health studies – improving accuracy to provide better diagnosis and treatment.
https://www.gov.uk/government/news/mhra-led-study-reveals-major-inconsistencies-in-global-microbiome-research?utm_medium=email&utm_campaign=govuk-notifications-topic&utm_source=642e6fe6-a7ad-4a0b-8132-8b72195ff2f6&utm_content=weekly
0
25
6
New EMA draft guidance on non-inferiority and equivalence trials
www.ema.europa.eu/en/non-infer...
loading . . .
Non-inferiority and equivalence comparisons in clinical trials - Scientific guideline | European Medicines Agency (EMA)
https://www.ema.europa.eu/en/non-inferiority-equivalence-comparisons-clinical-trials-scientific-guideline
3 months ago
0
0
0
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...
loading . . .
Microsoft Virtual Events Powered by Teams
Microsoft Virtual Events Powered by Teams
https://events.teams.microsoft.com/event/a90f5fae-3b8a-4869-aaeb-f855d89d190d@9c5012c9-b616-44c2-a917-66814fbe3e87
3 months ago
0
0
0
reposted by
Eslam Maher
Emily Moin
3 months ago
"[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...
loading . . .
Artificial Intelligence in Peer Review
Like David Foster Wallace’s tale of 2 fish that don’t notice the water they’re swimming in because it’s all around them,1 the medical community has at times taken for granted peer review and its centr...
https://jamanetwork.com/journals/jama/fullarticle/2838453?guestAccessKey=084dd038-2caf-4a39-8912-17ae04f86358&utm_source=bluesky&utm_medium=social_jama&utm_term=18660272663&utm_campaign=article_alert&linkId=875668600
4
47
9
LLMs are net negative to humanity
www.nature.com/articles/d41...
loading . . .
Preprint site arXiv is banning computer-science reviews: here’s why
The repository is taking steps to tackle a surge in low quality, AI-generated content.
https://www.nature.com/articles/d41586-025-03664-7
3 months ago
0
0
0
"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."
add a skeleton here at some point
3 months ago
0
0
0
"...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...
3 months ago
0
0
0
Load more
feeds!
log in