Eslam Maher

Investigating estimand considerations in adaptive trials: a systematic review - Trials Background Randomised controlled trials (RCTs) are the gold standard for evaluating treatment effects, with the results informing policy and clinical practice. To ensure appropriate methods are utilis...

Investigating estimand considerations in adaptive trials: a systematic review by @statsci.bsky.social link.springer.com/article/10.1...

Regulatory Expectations for Bayesian Methods in Drug and Biologic Clinical Trials: A Practical Perspective on FDA's 2026 Draft Guidance The U.S. Food and Drug Administration (FDA) released a landmark draft guidance in January 2026 on the use of Bayesian methodology to support primary inference in clinical trials of drugs and biologica...

Check his preprint here: arxiv.org/abs/2601.14701

Welcome! You are invited to join a webinar: Boston Chapter of the ASA Webinar: A Perspective Review of FDA's Draft Guidance on the Use of Bayesian Methodology in Clinical Trials of Drug and Biological... Join the Boston Chapter of the ASA for an insightful 1-hour webinar featuring Dr. Yuan Ji, Professor of Biostatistics at The University of Chicago, as he shares his perspective on the FDA's Draft Guid...

The Boston Chapter of the ASA is hosting a free 1-hour webinar to discuss the FDA's draft guidance on Bayesian Methods in Clinical Trials, with Yuan Ji sanofi.zoom.us/webinar/regi...

3 March, 5 PM London time

CC @realised-ihi.bsky.social

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

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?

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 - 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...

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_...

Figure 3. Cumulative incidence of metastatic recurrence among adolescents and young adults in California. A, B, and C plots illustrate cervical, colorectal, and melanoma cancers. Graphs show % cumulative incidence vs months from cancer diagnosis.

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 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...

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 Covariate adjustment aims to improve the statistical efficiency of randomized trials by incorporating information from baseline covariates. Popular methods for covariate adjustment include analysis...

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....

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...

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 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…

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

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…

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

RobinCar2: Reliable Covariate Adjustment Package – RCONIS Research Consulting and Innovative Solutions.

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

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...

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 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

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

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.

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

Is Repeated Bayesian Interim Analysis Consequence-Free? The paper mixes two ideas, which creates a great deal of confusion: choice of priors, and sequential assessment. These ideas need to be separated. Differences of opinion about priors will have a sim...

Also see great discussion @f2harrell.bsky.social here discourse.datamethods.org/t/is-repeate...

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

Estimands in Clinical Trials This book gives guidance on implementing the estimand framework in diverse trial settings and explores real-world case studies.

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

#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 ...

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 misinterpreted Interpretation of numerous MRI data may be incorrect: blood flow is not a reliable indicator of brain activity.

"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-...

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

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

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...

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

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...

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

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...

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