European drug regulators walk back on transparency promise
The European Heads of Medicines Agencies appear to have broken their promise to take action to improve clinical trial transparency across Europe. This creates a danger of over 3,400 drug trials never making their results public.
In July 2021, the Heads of Medicines Agencies committed to “prepare an overview of the actions initiated by the Member States to improve the compliance/knowledge of the sponsors in relation to making trial results public,” and to circulate a “best practice document” to all national drug regulators in Europe “with a view to encourage the [regulators] to further improve their efforts in securing that the sponsors fulfill their obligations.”
The Heads of Medicine Agencies now appear to have backtracked on this commitment.
Some national regulators have made strong efforts to improve trial reporting within their countries, with remarkable success. Trial reporting has surged in their countries, as the chart for major sponsors in Belgium below shows.
Other regulators seem not to have taken any action.
For example, Italian regulator AIFA appears not to have taken action, and many major Italian research institutions continue to have a terrible track record of transparency. The National Cancer Institute in Italy alone has run 102 drug trials but not made a single trial result public on EudraCT, in violation of transparency rules.
Successful approaches used by national regulators include sending out reminders to parties responsible for missing trial results – which some regulators have done, but others have not. The promised (but not delivered) Heads of Medicine Agencies document would have collated such approaches to enable all regulators to adopt successful practices.
Today, five health groups are writing to the Heads of Medicine Agencies urging them to deliver on their promise.
Their letter notes that:
"Unless [national regulators] actively encourage and support sponsors in meeting their EudraCT reporting obligations – both prospectively and retrospectively – these missing trial results will leave gaps in the medical evidence base that will undermine clinical practice and health technology assessment across Member States for many years to come, harming European patients and leading to the suboptimal allocation of scarce public funds."
"Rapid and decisive action is required to prevent legacy trial data from becoming irretrievably lost."
"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 and deserve HMA support."
The signatory groups are:
Cochrane
Concilium Scientific
Health Action International
Transparency International Global Health Programme
TranspariMED
The full letter can be downloaded below.