European national regulators, the European Medicines Agency and the European Commission have launched discussions on how to improve clinical trial reporting in Europe.
Currently, over 4,000 clinical trials of medicines are missing results on the European trial registry, in violation of long-standing transparency rules.
The outcomes of many of those trials, which typically involved hundreds of patients each, are in acute danger of being irretrievably lost unless the companies and institutions that ran them upload their results soon.
Alarmed by the risks this poses to patients and public health, 18 patient and medical groups including TranspariMED in May wrote to the Heads of Medicines Agencies [HMA], the network bringing together all national medicines regulators across Europe, asking them to ensure that all national medicines regulators in Europe directly contact all trial sponsors that have left results unreported.
In response, the Heads of Medicines Agencies have now written that:
“[T]he letter was discussed at an HMA Management Group meeting on 19 May 2021. All of the members of the management group recognise the importance of the sponsors fulfilling their obligation to make trial results public on EudraCT.”
“HMA is not in a position where the organisation can impose standards on the national competent authorities [national medicines regulators] though.”
“HMA will reach out to the European Commission and the European Medicines Agency with a view to initiate joint actions to improve clinical trial sponsors’ compliance with CTIMP results reporting requirements.”
TranspariMED today followed up with HMA, welcoming its engagement while noting that HMA itself can and should do more in the short term. Specifically, HMA should:
Provide a forum for national regulators in which these can jointly develop common minimum standards for following up on unreported clinical trials, and jointly agree to adhere to those standards on a voluntary basis
Compile an overview of national laws and regulations governing clinical trial reporting in each of the 27 EU Member States
Till Bruckner, founder of TranspariMED, said:
“TranspariMED strongly welcomes HMA’s decision to put the issue of missing clinical trial results onto the agenda, and hopes that HMA will now actively work towards the creation of a regulatory system that no longer idly stands by when rules are broken, taxpayers’ money is wasted, and patients’ interests sidelined.”
“Meanwhile, there is no need for national medicines regulators to wait until a European consensus has been reached. For example, regulators in Denmark and Austria are already actively engaging with trial sponsors in their countries to ensure that they make their results public, with considerable success.”
“Running a single clinical trial can cost millions of Euros, but that money is wasted if the results are never made public. Is it really too much to ask regulators to send out a few hundred reminder letters to prevent valuable medical knowledge from being lost forever?”
Earlier this week, Norway’s Dam Foundation in collaboration with TranspariMED published a report featuring a statement by the Norwegian Medicines Agency, which argued that “we find it justifiable not to introduce a new system for a follow up of the sponsor’s responsibility” against a backdrop of dozens of missing results of clinical trials involving Norwegian patients.
(While Norway is not a member of the European Union, it has joined the regulatory umbrella of the European Medicines Agency and is therefore bound to adhere to its transparency rules.)
To the best of TranspariMED’s knowledge, medicines regulators in Germany, France, Italy, Spain, the Netherlands, Belgium and Ireland have so far also not contacted pharma companies and research institutions in their countries that are breaking the rules. However, this may be changing fast.
In the United States, sponsors face fines of over $12,000 for each day per trial that is missing results. The FDA has recently started enforcing that law.
See here for the original letter sent to HMA by 18 health and patient groups in May.
HMA’s response (see the annex) and today’s letter by TranspariMED can be downloaded below: