European medicine regulators oppose free clinical trial data access
Fear that ‘egotistical’ researchers could use the information to generate health scares
A paper written by key European Union regulators has argued against releasing full datasets of clinical trials, arguing that egotistical researchers might scan them for potential problems, generating health scares.
The potentially controversial claims are made by the European Medicines Agency's (EMA) senior medical officer Hans-Georg Eichler, executive director Guido Rasi, and officials from the national pharmaceutical regulators in the UK, France and the Netherlands.
Their paper, published in the PLoS Medicine journal, argues that scientists might hunt for problems in the data using ‘multiple exploratory re-runs of a dataset’, looking for a problem that might help make their name, sacrificing balance: “We submit that analyses by sponsor-independent scientists are not generated in a [conflict-of-interest]-free zone and, more often than not, ego trumps money. Independent analyses may therefore also be ‘vulnerable to distortion’.”
They also warn that patient confidentiality could be breached by releasing full clinical trial data, on the basis that individuals could possibly be identified in trials of ultra-rare disease treatments.