This week sees the culmination of some really important discussions here in Oxford about the reporting of clinical trials. Evidence-based medicine – using the best available evidence to provide the best healthcare – is a cornerstone of how doctors and others work, alongside the growing trend for patient involvement. It has been suggested that the two together can create the ideal (for those who want it) of “evidence–based patient choice”.
But for this ideal to be a reality, we need to be sure that all the evidence from trials is available.
In January 2013, a campaign called AllTrials was launched, calling for all past and present clinical trials to be registered and their results reported. Today, Oxford University Hospitals NHS Trust joins the 79611 people and 502 organisations that have so far signed the campaign. Alongside this central commitment to transparency and openness, the Biomedical Research Centre and Unit are launching a project to look back at their trials to assess publication rate, and identify how best to ensure publication of all trials.
Our efforts focus on this part of the campaign because, in the UK at least, the issue of registration has been addressed by regulation: from 30 September 2013, clinical trials must be registered in a publicly accessible database before they are given ethical approval.
You can read more about the hugely complex world of trial reporting in the “myths and objections” area of the AllTrials site, including reference to a 2010 report that they describe as “a very large study of publication bias for the NHS”. They looked at hundreds of separate studies of clinical trial publication. Overall, around half of all trials in the studies they examined had never published results, and positive trials were twice as likely to be published as those with negative results.
It’s a while since I was a researcher, but I’ve never understood the mindset that might lead one to hide a negative result. Forgive the trite example, but if I were trying to cure cancer, and the drug I set my hopes on didn’t work, I’d be mightily disappointed. But surely I’d only fleetingly consider this “negative” result a worthy secret rather than a vital contribution to the knowledge base?
Not making it known that a drug has been tried risks repeating time-wasting trials and potentially exposes patients to risk or denies them something that might help. There’s interesting debate in the scientific literature about what constitutes a negative result. For those of us in the real world, a result’s a result, and we owe it to ourselves to make sure they are all published. You can read the OUH news item about AllTrials here and watch this blog for more news on the publications review, as well as the other commitment we are making today: that information about trials patients may be eligible to join here is written in language they can understand. I’ve covered that before on this blog.
It’s no easy job in a Trust with over 1,300 active trials and studies, but please take us to task if we fail.