Munya Dimairo
@mdimairo.bsky.social
Senior Research Fellow. Statistician. Novel trial methods. Former Wellcome Trust & NIHR Doctoral Research Fellow. Views are my own. Google Scholar: https://scholar.google.co.uk/citations?user=HZ2wNeEAAAAJ&hl=en ORCID: https://orcid.org/0000-0002-9311-6920
We are seeking key stakeholders in clinical trials research and related decision-making processes to contribute to guidance development on statistical analysis plans for adaptive and platform trials and on the disclosure of interim information in these trials. See details below 👇🏾👇🏾
Great to be in Hastings where we announced 40 more neighborhoods will benefit from Pride in Place. Communities like this are the backbone to our society - that’s why we’re backing them to deliver the change they want to see.
#BMJExclusive: Doctors should not engage with any aspect of the NHS Federated Data Platform outside direct patient care because of its links to the controversial US tech giant Palantir, the BMA says https://bit.ly/3OnZxcG
Palantir and NHS: BMA to tell members to limit use of tech system
Doctors should not engage with any aspect of the NHS Federated Data Platform (FDP) outside direct patient care because of its links to the controversial US tech giant Palantir, the BMA says. The unio...
bmj.com
Delighted to share OPTIMISE-ROR – recommendations to help embed patient-reported outcomes (PROs) more meaningfully in dose-finding oncology trials. It sets out core PRO objectives to support tolerability assessment, dose selection, and PRO strategy for subsequent studies. tinyurl.com/45thervu.
International Consensus-Driven Recommendations for Patient-Reported Outcome Research Objectives in Early Phase Dose-Finding Oncology Trials: OPTIMISE-ROR - PubMed
This foundational guidance outlines key PRO research objectives in DFOTs. By facilitating the systematic integration of PROs, this guidance supports the utilization of patient-centered evidence for the tolerability and efficacy assessment of therapies to inform dose escalation, optimization, and reg …
tinyurl.com
'How to interpret hazard ratios', with @dominicmagirr.bsky.social and @timpmorris.bsky.social thestatsgeek.com/2026/01/15/h...
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…
thestatsgeek.com
Doug Altman was an internationally renowned statistician who served as The BMJ’s chief statistical adviser. Read about life and work that made this statistician a "citation millionaire" #BMJChristmas www.bmj.com/content/391/...
ICYMI: NEW PAPER "Evaluation of performance measures in predictive artificial intelligence models to support medical decisions: overview and guidance" --> doi.org/10.1016/j.la... #AI #Machinelearning #predictiveAI
Reports of decreasing youth drinking in high income countries often conclude that alcohol consumption will continue to decline. But these decreases are counterbalanced by increases in other regions www.bmj.com/content/391/...
Malnutrition with use of GLP-1 agonists is an underestimated real world harm doi.org/10.1136/bmj....
Malnutrition with use of GLP-1 agonists is an underestimated real world harm
Wraparound care for patients taking GLP-1 agonists must include assessment of nutritional status to identify the risk of malnutrition, writes Ellen Fallows Food insecurity is increasing, particularl...
doi.org
My open letter to Rachel Reeves (cc @ofcom.bsky.social, DSIT) Now O2 has broken the taboo, the big risk is other firms will likely follow suit... the Govt must step in to stop mobile, broadband and pay-TV firms increasing prices mid-contract by MORE than they said they would when people sign up.
📢 New publication in #Trials led by @suziecro.bsky.social with the HEALTHY STATS public involvement group: Supporting public involvement in defining estimands: a practical tool accessibly explaining the five key attributes of an estimand trialsjournal.biomedcentral.com/articles/10....
Supporting public involvement in defining estimands: a practical tool accessibly explaining the five key attributes of an estimand - Trials
Background An estimand is a precise description of the treatment effect a trial is aiming to find out. We previously identified that public partners (defined as patients and/or members of the public w...
trialsjournal.biomedcentral.com
Love to see this kind of science. New RCT shows aspirin likely harms patients with ischemic heart disease who got a stent and are already on a blood thinner. A lot of people fall into this trial's inclusion criteria. Kudos to France and Bayer for working on this. www.nejm.org/doi/full/10....
Aspirin in Patients with Chronic Coronary Syndrome Receiving Oral Anticoagulation | NEJM
The appropriate antithrombotic regimen for patients with chronic coronary syndrome who are at high atherothrombotic risk and receiving long-term oral anticoagulation remains unknown. We conducted a...
nejm.org
Well done Shafaq Aftab. When a reviewer stole her work and published it under his own name, she fought for a YEAR to get the journal to retract the paper. Just wondering why it took Wiley a YEAR to do this. 🧪 #academicsky retractionwatch.com/2025/10/03/w...
Wiley retracts study stolen by reviewer, following Retraction Watch coverage
A Wiley journal has retracted a paper more than a year after a researcher reported the work was hers and had been stolen by a reviewer for another journal. As we reported in July, Shafaq Aftab, now…
retractionwatch.com
Unwritten rule #1: Never give power to a human being afraid of going to jail for their crimes. My USA colleagues are in a find-out phase!!
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....
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...
tandfonline.com
People in the USA are not paying attention. Trump is consolidating power beyond what you can imagine. He is capturing all levers of power. By 2026, he will run 'elections' and deploy the military to polling stations and he will count the votes.
Group Sequential Trial Design Using Stepwise Monte Carlo for Increased Flexibility and Robustness onlinelibrary.wiley.com/doi/10.1002/...
Group Sequential Trial Design Using Stepwise Monte Carlo for Increased Flexibility and Robustness
Clinical trials are becoming increasingly complex, incorporating numerous parameters and degrees of freedom. Optimal analytic approaches for these intricate trial designs are often unavailable, neces....
onlinelibrary.wiley.com
Practical guidance for conducting high-quality and rapid interim analyses in adaptive clinical trials bmcmedicine.biomedcentral.com/articles/10....
Practical guidance for conducting high-quality and rapid interim analyses in adaptive clinical trials - BMC Medicine
Background Adaptive designs are increasingly being used in clinical trials within diverse clinical areas. They can offer advantages over traditional non-adaptive approaches, including improved efficiency and patient benefit. The level of improvement observed in practice depends to a large degree on conducting interim analyses (at which adaptations can be made to the trial based on collected data) rapidly and to a high standard. Methods The ROBust INterims for adaptive designs (ROBIN) project aimed to identify best practice for conducting high-quality and rapid interim analyses. This was done through evidence synthesis of published work, qualitative research with trial stakeholders working at public sector clinical trials units, engagement with patients and the public, and a meeting of trial stakeholders to discuss findings and agree recommendations. Results This paper provides recommendations for teams that conduct adaptive trials about how to ensure interim analyses are done rapidly and to a high standard. We break down recommendations by stage of the trial. We also identify a lack of methodology on how best to involve patients in adaptive trials and related decision-making. A limitation of our recommendations is that the research was mostly focused on UK academic settings, although we believe much of the recommendations are relevant in other countries and to industry-sponsored trials. Conclusions When following the recommendations outlined in this paper, the process of planning and executing interim analyses will be smoother; in turn, this will lead to more benefits from using adaptive designs.
bmcmedicine.biomedcentral.com
The TARGET reporting guidelines for target trial emulation studies have arrived! #EpiSky #CausalSky jamanetwork.com/journals/jam...
TARGET 2025 Statement
This Special Communication introduces the Transparent Reporting of Observational Studies Emulating a Target Trial (TARGET) 2025 guideline, a consensus-based guidance for reporting observational studie...
jamanetwork.com
onlinelibrary.wiley.com/doi/10.1002/...
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...
onlinelibrary.wiley.com
New publications on Confidence Intervals for Adaptive Trial Designs @mdimairo.bsky.social onlinelibrary.wiley.com/doi/10.1002/...
Confidence Intervals for Adaptive Trial Designs I: A Methodological Review
Regulatory guidance notes the need for caution in the interpretation of confidence intervals (CIs) constructed during and after an adaptive clinical trial. Conventional CIs of the treatment effects a...
onlinelibrary.wiley.com
Confidence Intervals for Adaptive Trial Designs I: A Methodological Review. David S. Robertson, Thomas Burnett, Babak Choodari-Oskooei, Munya Dimairo, Michael Grayling, Philip Pallmann, Thomas Jaki. Statistics in Medicine. onlinelibrary.wiley.com/doi/10.1002/...
Confidence Intervals for Adaptive Trial Designs I: A Methodological Review
Regulatory guidance notes the need for caution in the interpretation of confidence intervals (CIs) constructed during and after an adaptive clinical trial. Conventional CIs of the treatment effects a...
onlinelibrary.wiley.com
Confidence Intervals for Adaptive Trial Designs II: Case Study and Practical Guidance. David S. Robertson, Thomas Burnett, Babak Choodari-Oskooei, Munya Dimairo, Michael Grayling, Philip Pallmann, Thomas Jaki. Statistics in Medicine. onlinelibrary.wiley.com/doi/10.1002/...
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...
onlinelibrary.wiley.com
RFK Jr is destroying research on vaccine technology that has saved millions of lives in favor of antiquated vaccines that don’t work as well and take longer to produce. Killing mRNA vaccines will kill people. open.substack.com/pub/rasmusse...
What's Old is New and What's New is Dead
Ask not for whom the bell tolls, it tolls for mRNA vaccines
open.substack.com
The UK’s flagship health research programme promises breakthroughs, but beneath an NHS branded facade, critics are asking who really benefits from the database, heavily backed by industry and government. @mgtmccartney.bsky.social and @debscohen.bsky.social investigate www.bmj.com/content/390/...
APT-SAP project alert! 👇🏾 www.linkedin.com/posts/munyad...
Adaptive and platform trials (APTs) can be very efficient in addressing research questions in many ways, when implemented appropriately and robustly. | Munya Dimairo
Adaptive and platform trials (APTs) can be very efficient in addressing research questions in many ways, when implemented appropriately and robustly. Developing and implementing statistical analysis p...
linkedin.com
Catch-up on today's adverse event webinar here: www.statsci.co.uk/webinar-series
WEBINARS | StatsCI
statsci.co.uk
Rachel Phillips@rachpips.bsky.social · last yr.Next week we continue our adverse event special series. On Thursday 3rd July 1pm (BST), we host Inga Frantz who will be discussing their paper demonstrating the development and testing of a tool to assess the systematic collection of AEs in parenting intervention studies.
Design of platform trials with a change in the control treatment arm academic.oup.com/biometrics/a...
Design of platform trials with a change in the control treatment arm
ABSTRACT. Platform trials are an efficient way of testing multiple treatments. We consider platform trials where, if a treatment is found to be superior to
academic.oup.com
