Eslam Maher
@eslammaher.bsky.social
📤 34
📥 134
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Oncology trials and biostatistics
https://scholar.google.co.uk/citations?user=ZbSK3WwAAAAJ
New EMA draft guidance on non-inferiority and equivalence trials
www.ema.europa.eu/en/non-infer...
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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
about 15 hours ago
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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...
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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
about 15 hours ago
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reposted by
Eslam Maher
Emily Moin
7 days 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...
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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
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LLMs are net negative to humanity
www.nature.com/articles/d41...
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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
9 days ago
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"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
12 days ago
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"...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...
13 days ago
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Not me creating an account on X just to re-read all Frank Harrell vs Judea Pearl tweets. 😅
13 days ago
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This seed produces 30 successes in a row! 🤯 h/t Andi Fugard
@andifugard.info
www.linkedin.com/posts/andifu...
#rstats
14 days ago
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SAS laid off its China-based employees (400 of them!) and its Chinese website taken offline
www.scmp.com/tech/tech-tr...
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US software firm SAS exits China after 25 years, lays off about 400 staff
One of China’s top employers for 17 consecutive years, SAS follows other Western tech firms in scaling back local operations.
https://www.scmp.com/tech/tech-trends/article/3331099/us-software-firm-sas-exits-china-after-25-years-lays-about-400-staff
15 days ago
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reposted by
Eslam Maher
Darren Dahly
15 days ago
I'm increasingly proud to have written and published things before LLMs existed.
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Hierarchy of causal inference for treatment efficacy via
@f2harrell.bsky.social
16 days ago
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A very cool intro to measuring agreement
onlinelibrary.wiley.com/doi/10.1002/...
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Measuring Agreement in Diagnostics: A Practical Guide for Researchers
Healthcare professionals routinely perform clinical examinations and diagnostic assessments. How the findings of these assessments are interpreted can have significant implications for patient care a...
https://onlinelibrary.wiley.com/doi/10.1002/sim.70299
17 days ago
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Supporting the professional development of trial managers: how can you help?
link.springer.com/article/10.1...
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Supporting the professional development of trial managers: how can you help? - Trials
Clinical trial managers are central to the successful design and delivery of clinical trials, making them crucial within the research landscape. Yet, despite their vital contribution, many trial manag...
https://link.springer.com/article/10.1186/s13063-025-09199-6?utm_source=rct_congratemailt&utm_medium=email&utm_campaign=oa_20251024&utm_content=10.1186%2Fs13063-025-09199-6
20 days ago
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ISBS Webinar Series is hosting Dr. Carl-Fredrik Burman from stats innovation in AstraZeneca to discuss: “Bayesian Borrowing: Some Philosophical Thoughts on Statistical Inference” Time: Nov 7, 2025 11am-12pm EDT (4-5pm London) Abstract and Zoom Link:
www.linkedin.com/posts/cindy-...
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Dear Fellow Statisticians, We are pleased to announce an exciting seminar on clinical trial innovations as part of the ISBS Webinar Series. The seminar, titled “Bayesian Borrowing: Some… | Cindy Lu
Dear Fellow Statisticians, We are pleased to announce an exciting seminar on clinical trial innovations as part of the ISBS Webinar Series. The seminar, titled “Bayesian Borrowing: Some Philosophica...
https://www.linkedin.com/posts/cindy-lu-6b9ab7a_dear-fellow-statisticians-we-are-pleased-activity-7387600366584115201-vdB8?utm_source=share&utm_medium=member_desktop&rcm=ACoAAB6Tbb0BG91X2osX1uS7Qn-iBHSp7qUlfqk
22 days ago
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The MedxR package allows users to retrieve real-time or historical information about drug approvals, adverse events, product recalls, and pharmaceutical details
lightbluetitan.github.io/medxr/
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Access Drug Regulatory Data via FDA and Health Canada APIs
Provides functions to access drug regulatory data from public RESTful APIs including the FDA Open API and the Health Canada Drug Product Database API, retrieving real-time or historical information on...
https://lightbluetitan.github.io/medxr/
23 days ago
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reposted by
Eslam Maher
Peter Tennant
26 days ago
DEBATE: "Is AI the future of health and social science?" For those in London on 15 Dec 2025, don't miss this fun in person debate between me and David Bann sponsored by
@ncrm.ac.uk
! Will the arguments change anyone's mind? 🤔 Sign up to attend IN PERSON:
www.eventbrite.co.uk/e/is-ai-the-...
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An interactive session by Cytel to discuss any of the FDA Oncology guidances! October 29th, 2pm London
cytel.com/news-and-eve...
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Office Hours - FDA’s Oncology Guidances: Leveraging Advances in Oncology Trial Design for Regulatory Approval
https://cytel.com/news-and-events/office-hours-fdas-oncology-guidances-leveraging-advances-in-oncology-trial-design-for-regulatory-approval/
26 days ago
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reposted by
Eslam Maher
London School of Hygiene & Tropical Medicine
26 days ago
Low participation in medical trials puts millions of young people at risk Wendy Macdowall tells The Guardian about underrepresented groups in
#research
& need to understand how experiences of interventions differ
#PublicHealth
www.theguardian.com/society/2025...
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Low participation in medical trials puts millions of young people at risk
Exclusive: Data shows gen Z could miss out on new treatments because so few sign up for trials and studies in England
https://www.theguardian.com/society/2025/oct/20/low-participation-medical-trials-millions-young-people-risk
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University of California affiliated scholars took home five awards across medicine, physics, and chemistry in a single month
www.universityofcalifornia.edu/press-room/u...
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University of California sets world record for Nobel Prizes in a single year
“These remarkable achievements by five UC-affiliated Nobel Prize winners reflect the very best of the world-changing teaching, research, and public service happening across our University,” said UC Pr...
https://www.universityofcalifornia.edu/press-room/university-california-sets-world-record-nobel-prizes-single-year#:~:text=Since%201934%2C%2074%20UC%20faculty,of%20any%20institution%20in%20history
26 days ago
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The agenda for
@rinpharma.bsky.social
2025 conference is pretty cool
events.zoom.us/ev/Ai-geyS63...
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R/Pharma 2025
https://events.zoom.us/ev/Ai-geyS63AOzr-Tskeu2jwsPAZkX9yQixTAJuQzNT-h_rw24wX-p~AnyGxi92zGyWPS_7xPj-Oax9RjoaU3pZS0DjeX45ML084eyqq4qo6O7BMg
27 days ago
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nQuery's webinar on ICH E20. October 23
www.statsols.com/guides/impac...
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Impact of ICH E20 on Adaptive Design in Clinical Trials
Learn about adaptive design in clinical trials, key principles from ICH E20, and practical implications in our free webinar.
https://www.statsols.com/guides/impact-of-ich-e20-on-adaptive-design-in-clinical-trials
29 days ago
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FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Dosages for First-In-Human Trials
aacrjournals.org/clincancerre...
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FDA-AACR Strategies for Optimizing Dosages for Oncology Drug Products: Selecting Dosages for First-In-Human Trials
Abstract. Dosage optimization has become a focus in oncology drug development, as highlighted by recent U.S. Food and Drug Administration initiatives including Project Optimus. Traditionally, most onc...
https://aacrjournals.org/clincancerres/article/doi/10.1158/1078-0432.CCR-25-0095/766040/FDA-AACR-Strategies-for-Optimizing-Dosages-for
29 days ago
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Group-sequential designs: Interim analysis, primary analysis, confirmatory analysis, updated analysis, and decisive analysis...
trialsjournal.biomedcentral.com/articles/10....
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Clinical trials with interim analyses: standardizing terminology to increase clarity - Trials
Interim analyses for group-sequential decision-making are prevalent in clinical trials. Methodology is well established and has been routinely implemented over the last decades. Still, confusions and ...
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-08942-3
about 1 month ago
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Only ~1-2% of published trials that use the Simon's two-stage design reported an adjusted inference. And looks like <1% actually do the stage 2 test at all. Isn't this so disappointing given that it is so easy to do? Peer reviewers, funders? From 2021:
ascopubs.org/doi/10.1200/...
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Two-Stage Single-Arm Trials Are Rarely Analyzed Effectively or Reported Adequately | JCO Precision Oncology
PURPOSETwo-stage single-arm designs have historically been the most common design used in phase II oncology. They remain a mainstay today, particularly for trials in rare subgroups. Consequently, it i...
https://ascopubs.org/doi/10.1200/PO.21.00276
about 1 month ago
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MD Anderson Cancer Center has an institutional policy that phase 2 trials using treatments with limited prior safety data must have formal toxicity monitoring. Bayesian sequential monitoring is simple to design and ensures patient safety. It should be mandatory for all early-phase trials worldwide.
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Bayesian Clinical Trials at The University of Texas MD Anderson Cancer Center: An Update
In our previous article (Biswas, et al. Clinical Trials 2009), we showed that Bayesian methods had established a foothold in developing therapies in our institutional oncology trials. In this article,...
https://pmc.ncbi.nlm.nih.gov/articles/PMC6904523/
about 1 month ago
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“Skepticism is the highest duty and blind faith the one unpardonable sin.” — Thomas Henry Huxley, Essays on Controversial Questions (1889)
about 1 month ago
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reposted by
Eslam Maher
Peter Tennant
about 1 month ago
Last year, I had a paper rejected after 18 months with the
@amjepi.bsky.social
. It's the first time I've had a paper rejected after being invited for revisions. And the first time I've had a paper sent out to completely new reviewers. It stung so hard that it's taken me a year to look at again.
add a skeleton here at some point
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A lot of "beliefs" don't make sense to me once I put 95% confidence or credible intervals around its estimates..
about 1 month ago
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reposted by
Eslam Maher
Harriet Rumgay
about 1 month ago
Just out: the new IARC Evidence Summary Brief on alcohol and cancer 📰🍷 Proud to have contributed to this important work highlighting the global burden, economic impact, and the urgent need for policy action. Check it out here 👉
www.iarc.who.int/featured-new...
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reposted by
Eslam Maher
Paul Naish
about 1 month ago
Handling Missingness, Failures, and Non-Convergence in Simulation Studies: A Review of Current Practices and Recommendations
@amstatnews.bsky.social
#openaccess
www.tandfonline.com/doi/full/10....
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Handling Missingness, Failures, and Non-Convergence in Simulation Studies: A Review of Current Practices and Recommendations
Simulation studies are commonly used in methodological research for the empirical evaluation of data analysis methods. They generate artificial datasets under specified mechanisms and compare the p...
https://www.tandfonline.com/doi/full/10.1080/00031305.2025.2540002
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UK clinical trial approval times twice as fast with AI and reforms
www.gov.uk/government/n...
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UK clinical trial approval times twice as fast with AI and reforms
Patients receive earlier access to life-saving treatments as UK trial approval times cut in half from 91 to just 41 days.
https://www.gov.uk/government/news/uk-clinical-trial-approval-times-twice-as-fast-with-ai-and-reforms
about 1 month ago
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reposted by
Eslam Maher
Nature
about 1 month ago
This year’s Nobel Prize in Physiology or Medicine has been awarded to three scientists for discovering a class of immune cells that help to prevent the body from attacking its own tissues
go.nature.com/48QDdAJ
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Medicine Nobel goes to scientists who revealed secrets of immune system ‘regulation’
Mary Brunkow, Fred Ramsdell and Shimon Sakaguchi discovered cells that protect the body from autoimmune diseases.
https://go.nature.com/48QDdAJ
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RIP Jane Goodall, a truly inspirational human.
add a skeleton here at some point
about 1 month ago
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FDA Project Optimus guidance specifically states that it doesn't address radiopharmaceuticals. They have now posted a draft guidance for dose optimization for those agents here:
www.fda.gov/regulatory-i...
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Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization
Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oncology-therapeutic-radiopharmaceuticals-dosage-optimization-during-clinical-development
about 2 months ago
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Free webinar series on simulation guided trial design using FACTS
www.berryconsultants.com/resource/fac...
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FACTS Webinar Series – Simulation Guided Trial Design Using FACTS | News and Events
Berry Consultants is pleased to announce a complimentary 10-part webinar series focused on simulation guided trial design using FACTS software to be held October through December 2025.
https://www.berryconsultants.com/resource/facts-webinar-series
about 2 months ago
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Looks like BOIN is already replacing 3+3 designs
ascopubs.org/doi/10.1200/...
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Impact of Food and Drug Administration Project Optimus Guidance on Design of Early-Phase Clinical Trials | JCO Oncology Advances
PURPOSEFirst-in-human phase I trials serve as a critical bridge from laboratory research to clinical application. The US Food and Drug Administration (FDA) Project Optimus, launched in 2021, aims to r...
https://ascopubs.org/doi/10.1200/OA-25-00084
about 2 months ago
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RIP John Searle
en.wikipedia.org/wiki/John_Se...
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John Searle - Wikipedia
https://en.wikipedia.org/wiki/John_Searle#Ontological_subjectivity
about 2 months ago
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reposted by
Eslam Maher
London School of Hygiene & Tropical Medicine
about 2 months ago
Paracetamol use during pregnancy does not increase risk of autism Laurie Tomlinson explains best available evidence shows
#paracetamol
safe to take during pregnancy & urges parents to seek reputable sources of information, & medical advice from GP.
www.lshtm.ac.uk/newsevents/n...
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The Americas, Western Pacific, and Europe together hosted almost 90% of oncology trials worldwide. USA alone accounted for nearly 1/3rd...
www.nature.com/articles/s41...
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The WHO global landscape of cancer clinical trials - Nature Medicine
This Review of the WHO’s International Clinical Trials Registry Platform presents a snapshot of the global cancer trial landscape and provides critical empirical evidence to inform policy, practice an...
https://www.nature.com/articles/s41591-025-03926-x
about 2 months ago
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The C-index Multiverse
arxiv.org/abs/2508.14821
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The C-index Multiverse
Quantifying out-of-sample discrimination performance for time-to-event outcomes is a fundamental step for model evaluation and selection in the context of predictive modelling. The concordance index, ...
https://arxiv.org/abs/2508.14821
about 2 months ago
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CRAN's Task View for Clinical Trial Design, Monitoring, and Analysis has been updated in September 2025!
cran.r-project.org/web/views/Cl...
@thomasjaki.bsky.social
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CRAN Task View: Clinical Trial Design, Monitoring, and Analysis
Get Started
https://cran.r-project.org/web/views/ClinicalTrials.html
about 2 months ago
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UK clinical trials are under pressure
www.bmj.com/content/390/...
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UK clinical trials are under pressure
Reducing administrative and regulatory hurdles could restore momentum The number of industry clinical trials conducted in the UK has fallen substantially in recent years, both in absolute terms and r...
https://www.bmj.com/content/390/bmj.r1883
about 2 months ago
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FDA's draft guidance on the assessment of overall survival in oncology trials
www.fda.gov/regulatory-i...
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Overall Survival in Oncology Clinical Trials
Approaches to Assessment of Overall Survival in Oncology Clinical Trials
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/approaches-assessment-overall-survival-oncology-clinical-trials
2 months ago
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reposted by
Eslam Maher
Marion Campbell
2 months ago
I seem to have been discussing pilot and feasibility studies a lot this week. One question often asked is how big should my pilot/feasibility study be? 1/6
#MethodologyMonday
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reposted by
Eslam Maher
Suzie Cro
3 months ago
Are estimands being correctly used? A new review of protocols led by Timothy Clark shows many incorrectly defined estimand attributes. See the top areas for improvement & full results here:
trialsjournal.biomedcentral.com/articles/10....
#Trials
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reposted by
Eslam Maher
NIHR Research Support Service (RSS)
3 months ago
We are excited to launch our new Research Methods Academy: Seminar Series! Hear from leading experts on innovative and best practice methods to strengthen your research proposal. Find out more and register:
www.nihr.ac.uk/news/nihr-la...
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I think we need more studies like this, investigating OS surrogates in different malignancies:
www.sciencedirect.com/science/arti...
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Evaluating surrogates for overall survival in the adjuvant treatment of bladder cancer with chemotherapy
Surrogates for overall survival (OS) can expedite the development of adjuvant treatments for bladder cancer. We evaluated whether disease-free surviva…
https://www.sciencedirect.com/science/article/pii/S1078143925002698?via%3Dihub
3 months ago
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Great resource 👇
add a skeleton here at some point
3 months ago
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Prof
@vcornelius.bsky.social
@imperialctu.bsky.social
@statsci.bsky.social
inaugural lecture (in-person in Imperial & online)! 30 October 2025 "Under pressure: smarter trials for better health outcomes"
www.imperial.ac.uk/events/19688...
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Under pressure: smarter trials for better health outcomes
Join us for Professor Victoria Cornelius' inaugural lecture in person or online.
https://www.imperial.ac.uk/events/196880/under-pressure/
3 months ago
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reposted by
Eslam Maher
SCHARR Medical Statistics Group
3 months ago
onlinelibrary.wiley.com/doi/10.1002/...
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Confidence Intervals for Adaptive Trial Designs II: Case Study and Practical Guidance
In adaptive clinical trials, the conventional confidence interval (CI) for a treatment effect is prone to undesirable properties such as undercoverage and potential inconsistency with the final hypot...
https://onlinelibrary.wiley.com/doi/10.1002/sim.70202
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