Eslam Maher
@eslammaher.bsky.social
Oncology trials and biostatistics https://scholar.google.co.uk/citations?user=ZbSK3WwAAAAJ
Comments on ICH E20 draft guidance from all the leading UK experts on adaptive trial methodology!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
Comments on ICH E20 draft guidance from all the leading UK experts on adaptive trial methodology!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...
stat.ethz.ch/R-manual/R-d...
R: R News
stat.ethz.ch
December 10, 2025 at 5:27 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...
stat.ethz.ch/R-manual/R-d...
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...
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
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...
simonelgato.github.io/2025/12/06/n...
TiTE-STEIN www.tandfonline.com/doi/full/10....
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 ...
www.tandfonline.com
December 6, 2025 at 10:22 PM
TiTE-STEIN www.tandfonline.com/doi/full/10....
Version 2.0 of crmPack
www.rconis.com/blog/crmPack...
www.rconis.com/blog/crmPack...
crmPack 2.0: A Major Milestone for Adaptive Dose Escalation Trials – RCONIS
Research Consulting and Innovative Solutions.
www.rconis.com
December 6, 2025 at 12:09 PM
Version 2.0 of crmPack
www.rconis.com/blog/crmPack...
www.rconis.com/blog/crmPack...
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...
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
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...
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...
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/
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
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/
pubmed.ncbi.nlm.nih.gov/37639251/
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
Stakeholder Perspectives on Randomized Clinical Trials for Children With Poor-Prognosis Cancers jamanetwork.com/journals/jam...
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
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".
Reposted by Eslam Maher
"... 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#...
How to rescale examination marks (with added bonus of free Excel sheet).
senns.uk/wprose.html#...
Guernsey McPearson Prose
Continuitis,
Dichotomania and the Tetrachoric Coefficient of Correlation
senns.uk
November 26, 2025 at 10:22 AM
"... 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#...
How to rescale examination marks (with added bonus of free Excel sheet).
senns.uk/wprose.html#...
Reposted by Eslam Maher
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...
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...
November 24, 2025 at 11:28 AM
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...
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-...
www.linkedin.com/posts/pavel-...
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...
www.linkedin.com
November 21, 2025 at 10:12 AM
NIHR Statistics: A two-part webinar series on Practical Approaches to Dose Optimisation in Oncology Trials.
www.linkedin.com/posts/pavel-...
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.
😆
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.
😆
CDC has overhauled its website to assert that “the claim ‘vaccines do not cause autism’ is not an evidence-based claim”
November 21, 2025 at 7:45 AM
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.
😆
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/...
www.fda.gov/media/71147/...
www.fda.gov
November 18, 2025 at 5:13 PM
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/...
www.fda.gov/media/71147/...
There seems to be Cloudfare disruption leading to limited access to Wiley/Elsevier...
November 18, 2025 at 1:34 PM
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/...
journals.sagepub.com/doi/10.1177/...
Sage Journals: Discover world-class research
Subscription and open access journals from Sage, the world's leading independent academic publisher.
journals.sagepub.com
November 18, 2025 at 12:42 PM
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/...
journals.sagepub.com/doi/10.1177/...
Reposted by Eslam Maher
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
November 16, 2025 at 2:48 PM
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
Reposted by Eslam Maher
Perhaps this is why so much microbiome research is hard to believe.
www.gov.uk/government/n...
www.gov.uk/government/n...
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.
www.gov.uk
November 15, 2025 at 11:32 PM
Perhaps this is why so much microbiome research is hard to believe.
www.gov.uk/government/n...
www.gov.uk/government/n...
New EMA draft guidance on non-inferiority and equivalence trials www.ema.europa.eu/en/non-infer...
Non-inferiority and equivalence comparisons in clinical trials - Scientific guideline | European Medicines Agency (EMA)
www.ema.europa.eu
November 15, 2025 at 1:03 PM
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...
9 December, 2:00 PM - 3:00 PM GMT
events.teams.microsoft.com/event/a90f5f...
Microsoft Virtual Events Powered by Teams
Microsoft Virtual Events Powered by Teams
events.teams.microsoft.com
November 15, 2025 at 12:55 PM
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...
9 December, 2:00 PM - 3:00 PM GMT
events.teams.microsoft.com/event/a90f5f...
Reposted by Eslam Maher
"[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...
Citation needed?
jamanetwork.com/journals/jam...
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...
jamanetwork.com
November 9, 2025 at 2:14 PM
"[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...
Citation needed?
jamanetwork.com/journals/jam...
LLMs are net negative to humanity
www.nature.com/articles/d41...
www.nature.com/articles/d41...
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.
www.nature.com
November 7, 2025 at 2:42 PM
LLMs are net negative to humanity
www.nature.com/articles/d41...
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."
American Medical Association Introduces New Highly Effective Placebo Doctors https://theonion.com/american-medical-association-introduces-new-highly-effe-1819576542/
November 4, 2025 at 3:30 PM
"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...
Stephen Senn errorstatistics.com/2020/01/20/s...
November 3, 2025 at 1:44 PM
"...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...
Stephen Senn errorstatistics.com/2020/01/20/s...
Not me creating an account on X just to re-read all Frank Harrell vs Judea Pearl tweets. 😅
November 3, 2025 at 1:34 PM
Not me creating an account on X just to re-read all Frank Harrell vs Judea Pearl tweets. 😅