Background I, Richard Emsley and Darren Dahly wrote a review (here) of a trial of lopinavir and ritonavir for people hospitalised with Covid-19 infection , that was published in the New England Journal of Medicine (paper here), and was one of the first trials of treatments for the current pandemic to come out.  It was a … Continue reading Comment on Thomas Jaki’s response to “Statistical review of A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19 by B. Cao et al”

Disclosure: the BILCAP trial was run by the unit where I currently work, though I had no involvement in it. Plenary Session podcast number 1.52 (here) was about the BILCAP trial (Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study), which was published recently in Lancet Oncology.  … Continue reading Plenary session: BILCAP and dichotomania

I spotted something about this trial on Twitter and I followed it up because I’ve been involved in trials in this area (out-of-hospital cardiac arrest; the PARAMEDIC and PARAMEDIC2 trials).  It raises a few interesting design issues that are more widely relevant than just to cardiac arrest trials, so that’s why I’m writing about it … Continue reading INCEPTION trial

This paper, in which John Laffey and Brian Kavanagh discuss some of the issues in critical care trials, was published recently in Lancet Respiratory Diseases.  Their main point, which seems sound, is that one of the reasons for the large number of "negative" (urgh) trials in critical care is that conditions that trials seek to … Continue reading Comments on “Negative trials in critical care: why most research is probably wrong”

I don't really want to write again and again about the New England Journal of Medicine and p-values for baseline characteristics, but just to continue the story from previous posts (here and here)... I got in touch with the journal to raise the issue. To recap: in a recent submission of a clinical trial report, we were … Continue reading NEJM – definitely the last time

Sorry for going on yet again about the New England Journal of Medicine, but I recently had the experience of publishing a trial there (this one) and interacting with their statistical guidelines, which I have discussed before (here and here). The issue about p-values for baseline characteristics came up, of course.  Here's what came back … Continue reading New England Journal of Medicine for the last time

I was part of a team that conducted a clinical trial, and we submitted the final report to a well-known journal.  The intervention looked as though it had little effect on the nominated primary outcome, but had beneficial effects on important secondary outcomes. Here are some of the comments that came back from the journal's … Continue reading Editor’s feedback

Here is the paper Here is the supplementary material This one had a fair bit of attention on Twitter from the  likes of Frank Harrell (here) and Andrew Althouse (here) so I thought it was worth posting something. A new trial in the New England Journal tested ECMO (extracorporeal membrane oxygenation) for patients with severe ARDS … Continue reading ECMO for ARDS; car crash RCT

This is about the THAPCA trial, published in NEJM in 2015 (paper here) .  It’s a trial of hypothermia after paediatric cardiac arrest, randomising children aged between 2 days and 18 years to either normothermia or hypothermia, started within 6 hours of return of circulation.  First of all, let me say that’s a challenging trial, … Continue reading Cool

Some time ago I wrote a post complaining that the New England Journal of Medicine was promoting testing of baseline characteristics in randomised trials, in their Instructions for Authors (post is here).  After I wrote that I wondered if I was being fair; it could possibly refer to comparisons of outcomes, not baseline characteristics. The … Continue reading NEJM again