Eslam Maher
eslammaher.bsky.social
Eslam Maher
@eslammaher.bsky.social
Covariate adjustment in trials with survival endpoints using RobinCar2 www.rconis.com/blog/robinca...
RobinCar2: Reliable Covariate Adjustment Package – RCONIS
Research Consulting and Innovative Solutions.
www.rconis.com
January 15, 2026 at 10:31 AM
New US FDA Draft Guidance: Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products
www.fda.gov/regulatory-i...
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This draft guidance provides guidance to sponsors and applicants on the appropriate use of Bayesian methods in clinical trials.
www.fda.gov
January 9, 2026 at 5:48 PM
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
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...
us06web.zoom.us
January 8, 2026 at 12:15 PM
New book! Estimands in Clinical Trials: A Practical Guide (Springer) link.springer.com/book/10.1007...
Estimands in Clinical Trials
This book gives guidance on implementing the estimand framework in diverse trial settings and explores real-world case studies.
link.springer.com
January 7, 2026 at 3:58 PM
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...
#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 ...
www.linkedin.com
December 30, 2025 at 1:34 PM
Reposted by Eslam Maher
"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-...
40 percent of MRI signals misinterpreted
Interpretation of numerous MRI data may be incorrect: blood flow is not a reliable indicator of brain activity.
www.tum.de
December 28, 2025 at 8:40 AM
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/...
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...
evidence.nejm.org
December 18, 2025 at 2:22 PM
Why are 3+3 phase 1 designs still being used? Frustrating
December 16, 2025 at 10:39 AM
Reposted by Eslam Maher
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...
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...
www.thelancet.com
December 13, 2025 at 2:04 PM
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-...
Regulations.gov
www.regulations.gov
December 10, 2025 at 11:38 AM
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...
R: R News
stat.ethz.ch
December 10, 2025 at 5:27 AM
Reposted by Eslam Maher
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...
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...
simonelgato.github.io
December 6, 2025 at 3:56 PM
Reposted by Eslam Maher
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...
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...
www.jclinepi.com
December 5, 2025 at 1:29 PM
Reposted by Eslam Maher
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/
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 …
pubmed.ncbi.nlm.nih.gov
December 4, 2025 at 4:19 PM
Stakeholder Perspectives on Randomized Clinical Trials for Children With Poor-Prognosis Cancers jamanetwork.com/journals/jam...
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.
jamanetwork.com
December 5, 2025 at 10:41 AM
Reposted by Eslam Maher
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".
November 27, 2025 at 12:05 PM