Back in November last year, I wrote about a particular class of open data – that regarding clinical trials data. I pointed out that of all open data, it is arguably the most important, because it can literally save lives – huge numbers of them. That post was by way of a taster for future columns – like this one – which touch on this area, since I believe it will become one of the most important battlegrounds for openness in the next few years.
One sign of this area's growing importance is the fact that the European Clinical Trials Directive is being revised. The European Parliament has started debating this, and according to this report by David Hammerstein, the battle lines are being drawn up:
Today the first major discussion on the future of clinical trials in the EU took place in the lead committee on this legislative report. Rapporteur Glenis Willmott defended her amendments to the European Commission (EC) proposal and 15 MEPs took the floor to give the opinion of their political groups and to explain some of the amendments they will be presenting over the next 10 days. The final vote will take place on the 25th of April and then the Parliament will try to negotiate a final common text with the Council that represents EU member states.
In general the debate three different camps with regards to transparency and access to clinical trial data: The S and D [Socialists and Democrats] rapporteur Wilmott and others who support the requirement of an accessible clinical study report (CSR), some leading conservatives and liberals who do not want much greater transparency and Greens and Leftists who request open access to raw data, as well as CSRs.
Another group interested in both the European plans and clinical trials data is the UK Parliament's Science and Technology Select Committee, which has launched an inquiry on the subject:
Clinical trials in the UK are regulated by the Clinical Trials Directive which was transposed into UK law by the Medicines for Human Use (Clinical Trials) Regulations 2004. In December 2011, the Health Research Authority was created to protect and promote the interests of patients and the public in health research. In July 2012, the European Commission produced proposals to revise the Clinical Trials Directive.
Transparency and disclosure of clinical trial data have been topical recently, in part due to the recently published book Bad Pharma, by Dr Ben Goldacre. It highlighted that pharmaceutical companies are entitled to conduct numerous clinical trials on a new drug but publish selectively, thus skewing the evidence base available for doctors and patients seeking to make informed decisions.
Once again, I'm afraid that there isn't much time if you want to make a submission – the deadline is noon today (er, sorry about that...) So if you have strong feelings on this area, I urge you to submit something to firstname.lastname@example.org, even if it is very brief. But this is very much a preliminary investigation: the EU directive needs to be sorted out first before the UK implements it, so there will be plenty of time later to make your views known.