Eslam Maher
@eslammaher.bsky.social
📤 61
📥 165
📝 139
Oncology trials and biostatistics
https://scholar.google.co.uk/citations?user=ZbSK3WwAAAAJ
The OCTAVE framework for simulating trials:
onlinelibrary.wiley.com/doi/10.1002/...
will be presented
@hrb-tmrn.bsky.social
via Zoom
universityofgalway-ie.zoom.us/webinar/regi...
Apr 16, 2026 01:00 PM (London)
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Clinical Trial Simulation: Planning With the OCTAVE Framework, Implementation and Validation Principles
The adoption of complex innovative clinical trial designs has steadily increased in recent years. These are trial designs that have one or more unconventional features—often resulting in multiple sta...
https://onlinelibrary.wiley.com/doi/10.1002/sim.70449?af=R
1 day ago
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reposted by
Eslam Maher
JAMA Oncology
1 day ago
Incidentally detected spleen length ≥140 mm or volume ≥500 mL was associated with markedly elevated 5-year risk for hematologic cancer, liver cancer, and cirrhosis in adults from Denmark and the UK.
ja.ma/4dDEIVc
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Incidentally Detected Splenomegaly and Risk of Hematologic Cancer and Liver Disease
This cohort study evaluates relative and absolute risks of hematologic cancers, cirrhosis, and liver cancer according to spleen length and volume in individuals with incidentally detected splenomegaly.
https://ja.ma/4dDEIVc
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Listen to Scott Berry
@statberry.bsky.social
hosting Stephen Senn
@stephensenn.bsky.social
. They discuss adaptive trials
www.youtube.com/watch?v=Tnb0...
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A Visit with Stephen Senn: Time, Concurrent Controls, and the Bayesian Guidance
YouTube video by Berry Consultants
https://www.youtube.com/watch?v=Tnb0AUC_Dgk
2 days ago
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reposted by
Eslam Maher
Stephen Senn
3 days ago
So you carried out a controlled clinical trial? Bravo. Make sure you carry out a controlled analysis. You can bin those within-group standard errors, comparisons back to baselines and dynamite detonator plots for a start.
pubmed.ncbi.nlm.nih.gov/2277879/
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The graphical representation of clinical trials with particular reference to measurements over time - PubMed
Clinical trials are frequently analysed as if they were surveys when they are in fact experiments. In particular the experimental basis of clinical trials is rarely reflected in the graphs which are used to illustrate them. Proposals are made, and illustrated by example, as to how appropriate figure …
https://pubmed.ncbi.nlm.nih.gov/2277879/
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Webinar: Enhancing Clinical Study Reporting with the Estimand Framework Tuesday 21st April 2026, 14:00 - 15:30 (GMT)
psiweb.org/events/event...
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PSI
The community dedicated to leading and promoting the use of statistics within the healthcare industry for the benefit of patients.
https://psiweb.org/events/event-item/2026/04/21/default-calendar/enhancing-clinical-study-reporting-with-the-estimand-framework
2 days ago
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Five tenets for advancing evidence-based precision medicine
www.nature.com/articles/s41...
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Five tenets for advancing evidence-based precision medicine - Nature Medicine
Coral et al. outline five fundamental tenets to promote clinically meaningful, reproducible, scalable and equitable health outcomes through precision medicine.
https://www.nature.com/articles/s41591-026-04309-6
8 days ago
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Appraising ML prediction models
@maartenvsmeden.bsky.social
1) Share model and code 2) Predictors and language 3) Class imbalance & calibration 4) Model validation sample size 5) Is the model clinically useful in practice?
www.jclinepi.com/article/S089...
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Preliminary appraisal of machine learning based prediction models
A significant portion of healthcare research is devoted to the development of prediction models, yet the integration of these models into routine clinical care remains limited. Persistent barriers, su...
https://www.jclinepi.com/article/S0895-4356(26)00131-9/fulltext
8 days ago
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"In oncology, we have witnessed the evolution of early-stage designs from 3 + 3 designs to continual reassessment methods, to bayesian optimal interval designs, and to posterior predictive design. Similarly, late-stage designs have evolved from Simon 2-stage designs, 1/2
add a skeleton here at some point
8 days ago
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Preprint: On the Calibration of Bayesian Success Criteria and Operating Characteristics for Clinical Trials
arxiv.org/pdf/2603.20015
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https://arxiv.org/pdf/2603.20015
9 days ago
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reposted by
Eslam Maher
Darren Dahly
9 days ago
Cool little package on CRAN for adding a download data button into html files created from your Rmd.
cran.r-project.org/web/packages...
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COMMENTARY: What Makes an Estimand Useful? Guidance on the Choice of Intercurrent Event Strategies
@brennankahan.bsky.social
@suziecro.bsky.social
onlinelibrary.wiley.com/doi/full/10....
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What Makes an Estimand Useful? Guidance on the Choice of Intercurrent Event Strategies
While the use of estimands in randomized trials is increasing, there is little guidance on which intercurrent event strategies should be used. The article by Fleming et al. seeks to address this gap....
https://onlinelibrary.wiley.com/doi/full/10.1002/sim.70452
14 days ago
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Preprint: A critical review of clinical prediction models in oncology: is this SEERious research?
@gscollins.bsky.social
osf.io/preprints/me...
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OSF
https://osf.io/preprints/metaarxiv/zwexr_v1
15 days ago
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reposted by
Eslam Maher
Laure Wynants
15 days ago
✨ New open-access book✨ I’ve seen how powerful prediction models can be, but also how often they fall short. We wrote a book, covering not just development, but also when models are needed, and how to ensure real-world impact.
www.maastrichtuniversitypress.nl/cpm
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%%title%% %%sep%% Maastricht University Press
Open Access book by Luc Smits, Sander van Kuijk, and Laure Wynants: This open-access textbook offers a practical and comprehensive guide to developing, validating, and implementing clinical prediction...
https://www.maastrichtuniversitypress.nl/cpm
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reposted by
Eslam Maher
Jack Wilkinson
15 days ago
Shout out to all the peer reviewers out there insisting we add p-values to Table 1 to check for confounding in an RCT. You are so bad at your job, and will never know it. You think you are great. It must be great to be you.
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Webinar on INLA for Biostatistics 19 March, 11 am EST (4 pm London)
bayesian.org/isba-industr...
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ISBA Industrial Statistics Section Webinar | International Society for Bayesian Analysis
https://bayesian.org/isba-industrial-statistics-section-webinar/
15 days ago
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Antibiotic use and gut microbiome composition links from individual-level prescription data of 14,979 individuals
www.nature.com/articles/s41...
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Antibiotic use and gut microbiome composition links from individual-level prescription data of 14,979 individuals - Nature Medicine
Using individual-level data from the Swedish Prescribed Drug Register and fecal metagenomes of 14,979 individuals in Sweden, the authors examined the association between oral antibiotic use over 8 yea...
https://www.nature.com/articles/s41591-026-04284-y
16 days ago
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A biostatistician vacancy at NASA
careers.leidos.com/jobs/1745171...
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Biostatistician in Houston, Texas (No Remote)
Biostatistician in Houston, Texas (No Remote)
https://careers.leidos.com/jobs/17451718-biostatistician
18 days ago
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Happy Pi Day & birthday to Einstein! :D Annual reminder that it's really 2π, aka τ, that is more natural to use, but it is too late now.
18 days ago
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Patient-Reported Outcomes to Inform Tolerability Characterization in Cancer Trials: A Critical Perspective on Unresolved Methodological Issues
journals.sagepub.com/doi/10.1177/...
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Patient-Reported Outcomes to Inform Tolerability Characterization in Cancer Trials: A Critical Perspective on Unresolved Methodological Issues - Bill Byrom, John Devin Peipert, 2026
Patient-reported outcomes assessing treatment toxicity and its impact, and aspects of quality of life, have become increasingly important components of oncology...
https://journals.sagepub.com/doi/10.1177/10732748261432279
20 days ago
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R in Pharma's rpact workshop recording
www.youtube.com/watch?v=B12t...
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Flexible Clinical Trial Design, Simulation, and Analysis with the R Package {rpact}
YouTube video by R in Pharma
https://www.youtube.com/watch?v=B12tA4ctdeQ
21 days ago
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reposted by
Eslam Maher
Mid terms are November 3rd 2026. Go register voters.
25 days ago
Just learnt the difference between & and && in R
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Important reflections and considerations for oncology trials by the FDA (2026)
ascopubs.org/doi/10.1200/...
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Oncology Drug Development: Challenges of Increasingly Available Therapies
https://ascopubs.org/doi/10.1200/JCO-25-02840
24 days ago
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www.bigbookofr.com
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Big Book of R
https://www.bigbookofr.com/
24 days ago
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The Hochberg Procedure for the Comparison of Multiple End Points
jamanetwork.com/journals/jam...
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The Hochberg Procedure for the Comparison of Multiple End Points
This Guide to Statistics and Methods provides an overview of the Hochberg procedure, an effective tool for avoiding false-positive conclusions in clinical trials reporting multiple end points.
https://jamanetwork.com/journals/jama/fullarticle/2845970?utm_source=bluesky&utm_campaign=content-shareicons&utm_content=article_engagement&utm_medium=social&utm_term=030626
26 days ago
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BOP2 with both futility and efficacy analyses
www.tandfonline.com/doi/full/10....
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BOP2-FE: Bayesian optimal phase II design with futility and efficacy-stopping boundaries
The primary purpose of an oncology single-arm trial is to evaluate the effectiveness of anticancer agents and make a go/no-go decision while maintaining patient safety. We propose a flexible Bayesi...
https://www.tandfonline.com/doi/full/10.1080/10543406.2025.2558142
26 days ago
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Leveraging generative AI to transform statistical analysis plan authoring in clinical trials
journals.sagepub.com/doi/10.1177/...
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Leveraging generative AI to transform statistical analysis plan authoring in clinical trials - Rogier Landman, Birol Emir, Richard Zhang, Giannis Manousaridis, Yi-Chien Lee, Lili Jiang, Gordon Siu, Fe...
Background Statistical analysis plans are critical regulatory documents that define the statistical methodology, objectives, and data-handling procedures for cl...
https://journals.sagepub.com/doi/10.1177/17407745261422365
28 days ago
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rpsychologist.com/likelihood/
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Understanding Maximum Likelihood Estimation
A tool to understand maximum likelihood estimation
https://rpsychologist.com/likelihood/
28 days ago
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reposted by
Eslam Maher
Richard Riley (R²)
30 days ago
@glenmartin.bsky.social
is giving an online seminar: "Missing Data: The Missing Component in Guidance for Developing, Validating and Implementing Prediction Models" 📅 Date: Tuesday 10th March 2026 🕐 Time: 1–2pm GMT 📍 Location: Online 🔗 Register here to receive the Teams link:
lnkd.in/ejk7EFzC
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LinkedIn
This link will take you to a page that’s not on LinkedIn
https://lnkd.in/ejk7EFzC
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reposted by
Eslam Maher
Mid terms are November 3rd 2026. Go register voters.
about 1 month ago
new package alert! {tidychain} is a
#rstats
packaged inspired by the below authors experience in showing how an excel file was changed / manipulated by looking at the underlying xml files to prove fraud in research
datacolada.org/109package
usrbinr.codeberg.page/tidychain/
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tidychain
https://usrbinr.codeberg.page/tidychain/
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reposted by
Eslam Maher
Frank Harrell
about 1 month ago
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
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Practical elements to consider when emulating a target trial
When carefully designed and analyzed, target trial emulation, i.e., the analysis of observational data through the explicit emulation of the design components of randomized controlled trials (RCT), ca...
https://www.jclinepi.com/article/S0895-4356(26)00080-6/fulltext?rss=yes
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The `bmabasket` package used for Bayesian model averaging in basket trials was apparently removed from CRAN on 2025-12-22
cran.r-project.org/web/packages...
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CRAN: Package bmabasket
https://cran.r-project.org/web/packages/bmabasket/index.html
about 1 month ago
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Love this preprint
arxiv.org/abs/2506.17141
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The fundamental problem of risk prediction for individuals: health AI, uncertainty, and personalized medicine
Background: Clinical prediction models for a health condition are commonly evaluated regarding performance for a population, although decisions are made for individuals. The classic view relates uncer...
https://arxiv.org/abs/2506.17141
about 1 month ago
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A great opportunity for a PhD studentship in Sequential Multiple Assignment Randomised Trials (SMARTs) at Imperial's CTU with
@vcornelius.bsky.social
www.findaphd.com/phds/project...
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Developing Practical Method Based Guidance for Trial Statisticians for the Design and Analysis of SMART trials at Imperial College London on FindAPhD.com
PhD Project - Developing Practical Method Based Guidance for Trial Statisticians for the Design and Analysis of SMART trials at Imperial College London, listed on FindAPhD.com
https://www.findaphd.com/phds/project/developing-practical-method-based-guidance-for-trial-statisticians-for-the-design-and-analysis-of-smart-trials/?p195191
about 1 month ago
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Evidence of Unreliable Data and Poor Data Provenance in Clinical Prediction Model Research and Clinical Practice
www.medrxiv.org/content/10.6...
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Evidence of Unreliable Data and Poor Data Provenance in Clinical Prediction Model Research and Clinical Practice
Clinical prediction models are often created using large routinely collected datasets. It is essential that prediction models are developed with appropriate data and methods and transparently reported...
https://www.medrxiv.org/content/10.64898/2026.02.24.26347028v1
about 1 month ago
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Major Chinese funder to stop paying fees for 30 pricey open-access journals
www.science.org/content/arti...
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Major Chinese funder to stop paying fees for 30 pricey open-access journals
Move comes amid effort to grow the country’s own journals
https://www.science.org/content/article/major-china-funder-plans-curtail-spending-pricey-open-access-fees?utm_campaign=Science&utm_medium=ownedSocial&utm_source=facebook&fbclid=Iwb21leAQNRSRleHRuA2FlbQIxMQBzcnRjBmFwcF9pZAwzNTA2ODU1MzE3MjgAAR5SE8ruOXs9kANmvMia8IIkZjhnTtpR6Slhyfpl_Gu-7b-8-NlA9oDyeXOIiw_aem_ww4dtWgFSee-x1w0QGEUpA
about 1 month ago
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reposted by
Eslam Maher
Frank Harrell
about 1 month ago
The scary part of this is that we have created a
#Statistics
educational system that is guaranteed to create a low bar by teaching formulas, recipes, isolated stat tests, no experimental design, no Bayes, no questioning of assumptions, no questioning outcome variables or study designs, ...
#StatsSky
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gsDesign2 allows for designing trials with non-proportional hazards 🤩
cran.r-project.org/web/packages...
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gsDesign2: Group Sequential Design with Non-Constant Effect
The goal of 'gsDesign2' is to enable fixed or group sequential design under non-proportional hazards. To enable highly flexible enrollment, time-to-event and time-to-dropout assumptions, 'gsDesign2' o...
https://cran.r-project.org/web/packages/gsDesign2/
about 1 month ago
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An important topic for real world studies IMO: Einstein Circle Lecture - (The Lack of) Causal Inference in Prediction Models Feb 19, available via Zoom:
www.bihealth.org/en/notices/e...
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Einstein Circle Lecture | Nan van Geloven - News - BIH at Charité
How can prediction models support clinical decision-making when treatment effects are already embedded in the data used to develop them? In this lecture, Nan van Geloven, Professor of Biostatistics at...
https://www.bihealth.org/en/notices/einstein-circle-lecture-nan-van-geloven-the-lack-of-causal-inference-in-prediction-models
about 1 month ago
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reposted by
Eslam Maher
Georgia Tomova
about 1 month ago
200+ attendees joined us for this seminar with Mats Stensrud today. If you missed it, you can watch the recording here:
youtu.be/KL4eFZcw-sg
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Mats Stensrud | Why reporting hazard ratios in medical research is a bad idea
YouTube video by the Causal Inference Interest Group (CIIG)
https://youtu.be/KL4eFZcw-sg
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reposted by
Eslam Maher
Frank Harrell
about 1 month ago
1/2 Nail in the coffin of dichotomania:
@erik-van-zwet.bsky.social
's paper with
@stephensenn.bsky.social
and myself just published:
onlinelibrary.wiley.com/doi/10.1002/...
with extended discussion at
discourse.datamethods.org/t/dichotomiz...
#Statistics
#StatsSky
#rct
#clinicaltrial
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https://onlinelibrary.wiley.com/doi/10.1002/sim.70402
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Application of External Control Arms in Oncology Drug Development, 7 April Virtual or in-person in Washington
friendsofcancerresearch.org/event/applic...
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Application of External Control Arms in Oncology Drug Development - Friends of Cancer Research
Tuesday, April 7, 2026 10:00AM – 2:00PM ET The Ritz-Carlton 1150 22nd St NW, Washington, DC 20037 Conference will also be streamed virtually Register Today Friends of Cancer Research (Friends) is conv...
https://friendsofcancerresearch.org/event/application-of-external-control-arms-in-oncology-drug-development/
about 1 month ago
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Evaluating Safety Rules in Ongoing Dose-Escalation Trials Using BOIN: A Comparative Analysis of Criteria and Their Impact on Dose-Level Safety Assessments
onlinelibrary.wiley.com/doi/10.1002/...
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Evaluating Safety Rules in Ongoing Dose‐Escalation Trials Using BOIN: A Comparative Analysis of Criteria and Their Impact on Dose‐Level Safety Assessments
Ongoing dose-escalation trials present unique challenges in assessing safety, all with the goal to establish the maximum tolerated dose (MTD) and/or the recommended phase II dose (RP2D). Due to the e...
https://onlinelibrary.wiley.com/doi/10.1002/pst.70075
about 1 month ago
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Haven't read the statistics diaries in the post, but I love the idea of it.
add a skeleton here at some point
about 2 months ago
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I remember this day and my fascination with what physicists do. Exciting stuff!
add a skeleton here at some point
about 2 months ago
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crmPack v2.1 now supports backfilling simulations
www.rconis.com/blog/crmPack...
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crmPack 2.1: Backfill cohort simulations – RCONIS
Research Consulting and Innovative Solutions.
https://www.rconis.com/blog/crmPack-backfill/
about 2 months ago
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Investigating estimand considerations in adaptive trials: a systematic review by
@statsci.bsky.social
link.springer.com/article/10.1...
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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...
https://link.springer.com/article/10.1186/s13063-026-09490-0
about 2 months ago
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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
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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...
https://sanofi.zoom.us/webinar/register/WN_l_KH5pxSSx6YW7DjdaFV7Q#/registration
about 2 months ago
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reposted by
Eslam Maher
Frank Harrell
about 2 months 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
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Bayesian Design
https://hbiostat.org/bayes/design
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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-...
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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/#
about 2 months ago
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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...
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https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-reflection-paper-use-bayesian-methods-clinical-development_en.pdf
2 months ago
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