Pharma outperforms academia at reporting clinical trials – BMJ
Compliance with the European Commission’s requirement to report the findings of clinical trials is poor, but pharma is performing better than academia, according to extensive research.
The British Medical Journal (BMJ) reported that researchers from Oxford University’s Evidence-Based Medicine’s DataLab found that only 49.4% of clinical trials reported results.
Trials with commercial sponsors or were carried out by pharma companies, were more likely to post results, as were those that were sponsored by organisations that conducted a large number of trials.
European Union rules stipulate that the funders of clinical trials must post the results of all trials that have been entered on the EU Clinical Trials Register (EUCTR) since 2004. This has to be done within a year of the trial ending – but the European Medicine Agency (EMA), which runs the register has no way of penalising those who flout the rules.
The rules were put in place in an effort to increase transparency and to prevent companies from hiding results.
Also, the study found ‘extensive evidence of omissions and contradictory data’ in the EUCTR, with 29.4% of trials that were marked as ‘completed’ having given no completion date, making it impossible to tell if the requirement was fulfilled on time, or not.
Another area of concern was that some trials were mislabelled as ‘ongoing’ on the EUCTR in countries when they had ceased.
Gilead Sciences, Chiesi Farmaceutici, CSL Behring, Alcon, Genentech, Vertex Pharmaceuticals, Daiichi Sankyo, Almirall and Ferring Pharmaceuticals all reported a 100% record for reporting trials, with Sanofi, Bayer, Johnson & Johnson and Novo Nordisk close behind.
Among the worst performers are a high number of major universities, research bodies and hospitals across Europe.
To highlight the problem, the researchers have launched a new tracking website, http://eu.trialstracker.net, which details who is carrying out trials and which have been reported – or not. It is updated monthly.
The research team, who are behind the findings as well as the tracker, explain:
“The best currently available evidence shows that around half of all trials go unreported: this means that doctors and patients see only a partial, biased fraction of the true evidence. We cannot make informed decisions about treatments unless all the data is reported.
“Under EU rules, from December 2016, all trials on the European Union Clinical Trials Register (EUCTR) should post results within 12 months of completion. There has never been a rule as simple and clear as this, anywhere in the world.”
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