The umbrella body of European medicines agencies has announced that it will support its members’ efforts to improve clinical trial reporting, raising hopes that national regulators across Europe will finally step up their efforts to promote compliance with long-standing transparency rules.
At present, over 3,800 drug trials are missing results on the European trial registry, leaving large gaps in the medical evidence base and delaying the development of better treatments. These evidence gaps raise concerns that doctors and patients do not have access to full information on the benefits and harms of medicines already on the market.
Recent data show that some European countries do a far better job at trial reporting than others.
Heads of Medicine Agencies outlines plan to boost transparency
Today, the Heads of Medicine Agencies (HMA) umbrella group promised to address the issue:
“[T]here is universal support from the NCAs [national medicines regulators] for HMA to initiate joint actions with EMA and the Commission to improve clinical trial sponsors’ compliance with CTIMP [drug trial] results reporting requirements.”
“HMA Management Board has decided 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... Based on the overview, a best practice document will be circulated to all NCAs with a view to encourage the NCAs to further improve their efforts in securing that the sponsors fulfill their obligations.”
The letter also acknowledges that the new European trial registry, which will be launched at the end of January 2022, will not resolve the problem of older trials that are missing results:
“It is the view of HMA, that the ongoing efforts to promote awareness and provide training to sponsors in advance of the launch of [the new registry] CTIS and efforts to resolve the problem of the clinical trials that are still missing in [the old registry] EudraCT are not mutually exclusive. Thus, both issues will be raised via the joint HMA, EMA and Commission communication.”
HMA’s full letter can be downloaded here:
National action key to enforcing transparency rules
While transparency rules are set out at the European level, national medicines regulators in each country are responsible for enforcing those rules.
Article 94 of the the EU Clinical Trial Regulation, which will fully come into force in all member states on 31 January 2022, states that:
"Member States shall lay down rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive."
The Heads of Medicines Agencies told STAT News that:
“[I]t is the responsibility of the national competent authorities to report on clinical trials data… HMA is not in a position where we can oblige the national competent authorities to follow specific recommendations.”
The chart below shows national regulators' current performance. See this report for more details.
Significant step forward for clinical trial transparency
Till Bruckner, founder of TranspariMED, said:
“It is extremely encouraging that the Heads of Medicine Agencies will support the exchange of best practices across its members.”
“Data show that in Latvia, 73% of a cohort clinical trial results are made public, while in Norway the reporting rate is only 6%. These large differences indicate that there is a lot that national medicines regulators in Europe can learn from each other.”
“TranspariMED strongly welcomes this announcement. We hope that the Heads of Medicine Agencies will make its compilation of best practices public so that regulators worldwide can learn from innovative approaches pioneered in Europe.”
Today’s announcement by the Heads of Medicines Agencies (HMA) comes in the wake of sustained advocacy by a broad coalition of patient and health groups.
05 May: 18 civil society groups write to HMA urging it to take action over thousands of missing clinical trial results, warning that many companies and hospitals remain aware of long-standing transparency rules. They ask national regulators to send reminder letters to all trial sponsors that are in violation of reporting requirements.
06 May: A report documents widespread failures by the Belgian regulator AFMPS to secure compliance with transparency rules and ensure that trial data is up to date.
01 June: Major Norwegian trial sponsors agree to voluntarily upload their missing trial results, but Norway’s medicines regulator refuses to proactively boost compliance nationwide.
02 June: The Heads of Medicines Agencies promise to “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 results reporting requirements.”
05 July: A study by researchers at the University of Oxford documents widespread gaps in the European clinical trial registry, including invisible protocols and missing results, with large variations in the performance of individual European countries.
05 July: Media reports in multiple countries shed further light on regulators’ (in)actions. One of the largest trial sponsors in Italy tells the media that it has never been contacted by the national regulator AIFA over its missing clinical trial results; AIFA responds that it is catching up with an “accumulated delay due to technical problems”. Meanwhile, Dutch regulator CCMO states that it has fruitlessly tried to encourage trial reporting, but lacks legal powers to enforce the rules. German regulator Paul Ehrlich Institut simply refuses to respond to media enquiries. [Germany has two responsible regulators.]
06 July: German regulator BfArM reveals that it directly wrote to 1,100 clinical trial sponsors last year to remind them of their obligation to make clinical trial results public. It remains unclear whether any other national regulators in Europe have already done this. Austria’s BASG plans to do this in future.
08 July: Heads of Medicines Agencies announces that it will support its members’ efforts to improve clinical trial reporting (see blog above).
Today's letter from HMA can be downloaded here: