As part of their ‘The Life Scientific‘ series, which has previously featured an excellent interview with John Sulston on open data and the Human Genome Project, the BBC recently broadcast an interview with Sir Iain Chalmers, founder of the Cochrane Collaboration, in which he clearly states the dire need for open data concerning drug trials and emphasises a need to focus on the research questions and outcomes that really matter to patients.

He also emphasises how vital it is to publish the results of all trials to avoid an incomplete and biased scientific record which can lead to wasted resources following unpromising leads and compromises the safety of future trial participants.

This is not just a scientific disgrace but an ethical disgrace. Patients have suffered and died and resources have been wasted in both healthcare and research because people have not published what they should have published and that is tragic…We now have evidence that over 50% of trials go unreported. What are patients who actually contribute to these trials, participate in them, what are they to think of this behaviour? I think it’s indefensible and it worries me greatly that the medical establishment in my field has not been more forthright in putting it right.

Sir Iain gives the example of an unreported study of a drug very similar to that used in the infamous TGN1412 trial at Northwick Park in the UK, which led to six volunteers suffering multiple organ failure. The suffering of the single participant in the earlier study who developed similar symptoms did not prevent others from the same fate because the data and report was not available. This message about complete reporting was echoed by Patrick Vallance of GlaxoSmithKline, who have publicly stated that all trial results should be publicly available:

If you do an experiment with people…you have a duty to make the information available…but the second bit is what do you mean by data? Do you mean absolutely everything? The risk is if you do a massive data dump of absolutely everything you don’t actually get to information.

Trial data should not only be published but it should be publicly available to all, something with which the patients profiled on Who Needs Access? would thoroughly agree. Sir Iain’s work through the James Lind Foundation expands on this patient focus and he discusses questions such as why most trials registered for osteoarthritis of the knee are drug related when patients and their healthcare workers want research on surgical treatments, physiotherapy and knee prostheses.

First of all you’ve got people asking questions that are of no interest to the punters at the end of the research pipeline. Also, people look at silly outcomes. The thing is that it’s very important that a significant proportion of the patients and the public are informed enough to be better bullshit detectors, let’s put it that way.

One way to help make this happen is to ensure that all research publications and data relating to clinical trials are available openly so they can be accessed by patients and by those able to make them more useful to patients. For OKFN affiliated projects related to patient access to information, see Who Needs Access? and Open Research Reports.