A cross-party group of members of the European parliament has sent an open letter to regulators urging them to not drop the ball on over 3,400 clinical trial results that are still missing on the EudraCT trial registry, in violation of long-standing transparency rules.
Under European rules, institutions running investigative drug trials must make their results public within 12 months of trial completion. While the rules are set at the European level, responsibility for encouraging and enforcing compliance lies with the national medicines regulators in each country.
In their letter, the members of the European parliament affirmed that:
“It is… crucial that NCAs [national medicines regulators] actively encourage and support sponsors in meeting their EudraCT reporting obligations – both prospectively and retrospectively…”
“Taking into account the considerable direct and indirect costs of medical research waste to patients and taxpayers, such regulatory efforts have been highly cost-effective.”
The Heads of Medicines Agencies group should support its members by circulating a compendium of best practices, they demanded.
The Heads of Medicines Agencies had promised to compile such a document in 2021, but never produced it. In March 2022, a coalition of civil society groups had called on the group to revisit the issue.
Regulators in Austria, Belgium and Germany and other countries have already contacted rule-breaking pharma companies and institutions to remind them of their obligations, leading to strong improvements in trial reporting in those countries.
However, regulators elsewhere – including in France, Italy and Spain – still appear to be ignoring the large gaps in the medical evidence base left by pharma companies and research institutions in their countries. These gaps pose a danger to patients and public health across the continent.
Till Bruckner, founder of TranspariMED, said:
“Elected representatives from across the political spectrum have sent a loud and clear message that when transparency rules are broken, patients are harmed, and public money is wasted, regulators have a duty to step in.”
“It is completely unacceptable to encourage patients to volunteer for clinical trials, but then turn a blind eye when powerful companies and institutions neglect to make the results public. How difficult can it be to send out a few hundred warning letters?”
The seven parliamentarians who sent the letter to regulators represent all major factions in the European Parliament, ranging from the left to the conservatives:
Tilly Metz (Greens/EFA)
Jutta Paulus (Greens/EFA)
Kateřina Konečná (GUE/NGL)
Margrete Auken (Greens/EFA)
Michèle Rivasi (Greens/EFA)
Sara Cerdas (S&D)
Tomislav Sokol (EPP)
Their letter can be downloaded below: