Here’s a paper, and associated website, that we launch today: we have assessed, and then ranked, all the biggest drug companies in the world, to compare their public commitments on trials transparency. Regular readers will be familiar with this ongoing battle. In medicine we use the results of clinical trials to make informed treatments about which treatments work best; but the results of clinical trials are being routinely and legally withheld from doctors, researchers, and patients. This is a problem for industry sponsored trials, and for trials funded by governments and charities.

So what did we find? The results on the individual companies are important, but we also came across some fascinating patterns. While companies superficially have commitments to register and report clinical trials, in reality, there are often huge gaps in their policies, with many failing to include past trials (trials on the medicines we use today) and trials on off-label uses or unlicensed medicines, which are both important. We also found a huge range of commitments, which is exactly what audits are good for: identify who’s doing well, and who’s doing badly, so that everyone can learn from the best players. Lastly, as we went along we collected some fascinating examples of problematic policies, ambiguous language, inconsistent commitments, odd exclusions, and so on.

Overall this audit was a huge project, and we hope it will be widely used. You can see which companies are the best, and the worst. If you’re a researcher trying to get information on a trial from a company, you can use this to determine whether a company are breaching their commitments. If you’re an ethical investor (at the AllTrials campaign we have a network of dozens, covering €3.5t trillion of investments) you can use this to guide your activist investment choices. 

The full methods and results can be read, for free, in the paper. But we’ve also built a nice interactive website with mySociety (coming soon) to make the data more accessible. We think this is an important aspect of communicating results and making them useful, and used, and we’re keen for feedback on the site.

Coming next, we have ranked the policies of non-industry trial funders, and that paper will land shortly. We also have some great new and improved projects launching soon where we track the performance of institutions, rather than their promises: the proportion of their completed trials for which they have shared results. Meanwhile, you can read more about the battle for unreported clinical trials at AllTrials.net.

Onward!

There are recurring howls in my work. One of them is this: in general, if you don’t know which intervention works best, then you should randomise everyone, everywhere. This is for good reason: uncertainty costs lives, through sub-optimal treatment. Wherever randomised trials are the right approach, you should embed them in routine clinical care.

This is an argument I’ve made, with colleagues, in endless different places. New diabetes drugs are approved with woeful data, small numbers of patients in trials that only measure blood tests, rather than real-world outcomes such as heart attack, renal failure, or death: so let’s roll out new diabetes treatments in the NHS through randomised trials. We rely on observational studies to establish whether Tamiflu reduces complications of pneumonia: that’s silly, we can do trials, and we should. Statin treatment regimes in widespread use have never been compared head-to-head, using real-world outcomes such as heart attack, stroke, and death: so let’s embed randomised trials as cheaply as possible in routine clinical care (we’ve done two pilots, to document the barriers).

This week a dozen colleagues and I published yet another application of this basic, simple principle, as an editorial in the BMJ. The Cancer Drugs Fund is being marketed as a way to generate new knowledge: but in reality, the data that will be collected is weak, Read the rest of this entry »