Monthly Archives: November 2012
Dear readers, I have neglected you. Truth be told, I have half a dozen posts sitting in draft format, and no time to finish them off and present them to you. So in the mean time, here’s a little nugget that will hopefully enrage you as much as it did me.
Missing clinical trial data is a huge problem in medicine. The fact is that anyone can conduct as many trials of a drug as they like, but are under no obligation to tell anyone that they have done so, or to publish the results. Various attempts have been made to correct this ridiculous situation, but it still goes on. This means that whenever a drug is prescribed, despite the very best efforts of everyone from the doctor prescribing it to the medicines management teams who put it on the formulary, there is a very real risk that it either doesn’t work or is not safe.
Now, the EU appears to be making another attempt at correcting the situation, by proposing legislation requiring that the results of all clinical trials be reported directly to them. “Great!” I hear you cry, “that means we’ll get all the data and can make good decisions!” But actually, as the good Dr Goldacre pointed out on twitter yesterday evening, it means nothing of the sort. Here’s the proposed wording for the new EU Clinical Trials Directive, which is available online for anyone to view: (skip to article 34, item 3, page 49 in the pdf)
Within one year from the end of a clinical trial, the sponsor shall submit to the EU database a summary of the results of the clinical trial.
However, where, for scientific reasons, it is not possible to submit a summary of the results within one year, the summary of results shall be submitted as soon as it is available. In this case, the protocol shall specify when the results are going to be submitted, together with an explanation.
I’m sure it’s very clear to everyone that the wording of the directive is so woolly that the average 5 year old could probably worm their way out of complying with it.
So there you have it. This is the proposed new law governing regulatory oversight in the entire EU. The first vote on it appears not to be ‘til April 2013, so maybe there’s time to kick up a fuss about this yet. I’m currently investigating who would be best to get in touch with and hassle – when I find out I’ll share, and we can maybe get something done about this.