Archive for the ‘clinical trials’ Tag
It may seem strange, when the financial world at which my ire is mostly targeted is collapsing all around us, to look elsewhere. But I was inspired to do so by Saturday’s Bad Science column in the Guardian.
Approval for medicines depends on publication of research in peer-reviewed journals – of which there are thousands – amongst other things. A key element of the research is the clinical trial, which tests whether a new drug works, or has significant side effects. There’s a symbiotic relationship between the pharmaceutical companies producing the new drugs, the hospitals where the clinical trials are carried out, the clinicians who monitor them (and whose name tends to go on the published paper, which has an impact on their career prospects) and the publishers of the journals. Ben Goldacre, who writes the Bad Science column, has previously pointed out that statistically, a negative result in a clinical trial (one showing that the drug didn’t work) is just as valid as a positive result, yet it’s much less likely to get published. Peer-reviewed “scholarly” publishing is a profitable industry going through a transformation, yet it plays a crucial role in the medicines approval process.
The medicines regulators are really the right people to control the problem that Ben points out. It is, in fact, relatively simple to do so: first, clinical trials must be registered and published before they take place, and secondly, the results of all clinical trials must be published at their conclusion. It doesn’t matter whether or not they’re published in a peer-reviewed journal or not – of course, it would be better if everything was peer-reviewed – but it does matter that they are published, as in made available for the public (and regulators) to read. Unfortunately, in science, “published” has come to mean “accepted for publication in a peer-reviewed journal” – and science as a whole depends on this for determining promotion, funding and a whole lot more under the general heading of kudos.
The technology for this is even simpler than accounting. It is now commonplace to deposit so-called pre-prints of journal articles in pre-print repositories, so others working in the field can read them before the publishers get round to organising the peer review. It is normal in high-energy physics; it is less normal in biomedicine, because the pharmacos control it. The regulators can and should insist on it now.