DIA clinical forum, day 3
Well, the clinical forum is now pretty much over, and the Dianthus Medical exhibition stand is being dismantled around me even as I type this.
Since my last blog entry, I've been to a couple of interesting sessions in the medical writing track. Yesterday afternoon, I attended a session on the role of medical writers in publications, which is always a lively topic. It was nice to see that, at least among the people attending the session, messages about ethical standards seem to be very well understood.
Continue reading→DIA clinical forum, day 2
We're now on our second day at the DIA clinical forum. I've been to quite a variety of talks: one session on clinical study reports, another on validation of computerised systems, and most recently on statistical analysis of bioequivalence trials, where there was much discussion of whether it's acceptable to widen the acceptance criteria for bioequivalence if drugs have highly variable Cmax. It will be interesting to see what the new guideline on this says when it's published, supposedly later this year.
Continue reading→Live blog from the DIA clinical forum
I'm writing this from the DIA clinical forum in Nice, where Alice, Nancy and I are showing Dianthus Medical to the world of clinical research at the exhibition. We've had a nice leisurely start this morning, as the exhibition didn't start until 10.30, so I had plenty of time for a pre-breakfast run this morning. Running along the seafront in Nice is a particularly lovely thing to do, particularly early in the morning when the sun is not quite above the horizon: the light over the sea is beautiful.
Continue reading→Annoying sales calls
It's my first morning back in the office after a lovely week's holiday in the Lake District, and already I'm feeling grumpy again. Just had a sales call from someone claiming to be from Reuters (not sure whether he really was or not) trying to sell me some expensive business intelligence reports. As I've blogged before, I find unsolicited sales calls deeply annoying, and pretty much the first thing I asked him was "are you trying to sell me anything?", to which he answered that he wasn't. After proceeding to waste 5 minutes of my time, he then tried to sell me something.
Continue reading→HIV vaccine results
Today's big health news story is a "breakthrough" in HIV vaccine research, as the results of a study done in Thailand are announced. At the end of a 3-year study, 74 of 8,198 subjects became infected with HIV in the placebo group compared with 51 of 8,197 in the vaccine group. That's a vaccine efficacy of about 31%, or if you prefer, a risk ratio of 0.69.
Continue reading→New training date
The date of our next introduction to medical writing course is now confirmed as 26 February 2010. Continue reading→Bugs in showerheads
A schoolboy error in one of the health news stories from the BBC today provides further evidence for a theory I've recently been developing.
The headline reads Taking showers 'can make you ill'. Once you read more, however, you realise that the research on which it's based provides no evidence whatever that taking showers can make you ill. All it shows is that various unpleasant bugs, such as Mycobacterium avium, can lurk in shower heads. Given that most people shower every day and seldom develop mycobacterial infections, I suspect that any risk from such infected shower heads must be pretty low. For the journalist to write a headline like that is an egregious example of extrapolating beyond your data.
Continue reading→Conflicts of interest
We are no strangers to conflicts of interest in the world of medical writing. The best known case of this is when a pharmaceutical company has paid someone to write an article about one of their own drugs. The conflict of interest here is obvious. Because it is so obvious, however, journal editors are very well aware of the potential for bias in this situation, so such conflicts of interests are, in the main, transparent and well managed. That doesn't mean that some egregiously biased articles don't sometimes slip through the net, of course, but in my experience that doesn't happen often.
Continue reading→RTFM
One of the various roles I fulfil is sitting on a research ethics committee. For those unfamiliar with the system, all medical research involving human subjects needs to be reviewed and approved by a research ethics committee before it can take place. We make sure that subjects are not put at unnecessary risk and are properly informed about what they are letting themselves in for.
Continue reading→Interesting blog on ghostwriting
Kate Johnson, a medical journalist from Canada, has just written an excellent blog on medical ghostwriting. She makes a clear distinction between ghostwriting, which is unethical, and legitimate professional writing assistance, which, she argues, plays an important role in both improving the quality of publications and their timely appearance in the literature.
Continue reading→