Comprehensive results from clinical trials should be published on a public database – with financial penalties for those that do not submit their results on time and the requirement for transparency written into EU law, writes MEP
Too many results from clinical trials are misleading, biased or missing. It is time that all pharmaceutical companies and researchers made the full results of studies on new and existing drugs publicly available.
In my role as the European Parliament rapporteur, or lead legislator, for the revision of the European rules on clinical trials, I am calling for wide-ranging transparency measures. My report
was published this Monday. I want to see comprehensive results from clinical trials published on a public database. A summary of the results is not enough. Summaries written by those that carried out the research can be biased, and make a medicine sound more successful than it really is.
Independent researchers need access to the results of the trial in order to verify the sponsor's claims. I am proposing that a full clinical study report is published on the new European Union database. This is the same document that companies must submit to regulators for approval of their medicine, and therefore contains a full account of how the clinical trial was conducted and what the results were.
I also want to see financial penalties imposed on those that do not upload their results on time. The law in the United States requires all trial results to be uploaded within a year, but a 2012 audit found that 80 per cent of trials had failed to comply. If we are serious about openness in medicine then we have to levy fines on those not following the rules.
Numerous academic studies have found that around half of all trials are never published, usually those with negative or disappointing results. For too long unflattering studies have gone undisclosed. It is vital that we know about negative outcomes, otherwise trials can be conducted repeatedly before it becomes public knowledge that they are ineffective, or even dangerous.
There is still a long way to go, but it looks like we are making progress. Dr Ben Goldacre has shone a light on the issue with his book Bad Pharma
and his blog Bad Science
, and now the All Trials
campaign is doing a great job of putting pressure on pharmaceutical companies, researchers, regulators and legislators to improve the system.
Yesterday the campaign was given a huge boost when pharmaceutical giant GSK signed up
. I am determined to support these efforts by writing transparency measures into EU law, and creating a level playing field for all those who invest in clinical research. Now I must win the support of the rest of the parliament, across political groups. Once I have that mandate I will need to convince EU governments that this is the way forward.
But it looks like the focus of clinical trials is finally shifting towards patient safety and knowledge-based medicine. Because when a patient makes the decision to take part in a clinical trial, they do so to help advance medicine, to improve treatment for themselves and for those in a similar situation. They do not do it to help a particular company promote a particular drug.
Glenis Willmott MEP is the leader of Labour MEPs in the European Parliament and the party's spokesperson on health