New report flags gaps in clinical trial regulations across Europe
National medicines regulators in seven major European Union countries now have legal powers to impose fines of up to 250,000 Euros on clinical trial sponsors that fail to make the results of drug trials public as required by law, a new report launched today shows.
Furthermore, regulators in six countries are actively prompting trial sponsors to make the results of their past drug trials public, with remarkable success.
Conversely, regulators in four countries – France, Italy, Spain and Sweden – appear to be taking little or no action on missing drug trial results.
The report provides the first ever detailed overview of clinical trial transparency laws and enforcement mechanisms across major European countries. It finds that none of the countries covered have laws requiring the publication of clinical trial results that do not involve investigative drugs or medical devices.
Drug trials: glass half full
National medicines regulators in seven major European Union countries now have legal powers to impose fines of up to EUR 250,000 on clinical trial sponsors that fail to make the results of drug trials public as required by law. These powers only apply to drug trials launched after January 2022.
Regulators expect that monitoring data from the new European CTIS trial registry will enable them to detect and follow up on future violations. However, in practice, the process of imposing fines is likely to consume considerable regulatory resources.
Regulators in six countries – Austria, Belgium, Denmark, Finland, Germany, and the Netherlands – are actively prompting trial sponsors to make the results of their past drug trials public. Their efforts have been remarkably successful.
Regulators in four countries – France, Italy, Spain and Sweden – appear to be taking little or no action on missing drug trial results. This threatens to undermine European efforts to secure the 3,055 drug trial results that are still missing.
Other trials: uncertainties and gaps
Medical device trials. It is still unclear whether and how monitoring data from the new EUDAMED database will support national regulators’ efforts to ensure that medical device trial results are rapidly reported as required by law.
Other trials. There are currently no legal requirements to make the results of other clinical trials public. This regulatory vacuum is perpetuating costly medical research waste.
Call for action
Till Bruckner, founder of TranspariMED, said:
“The majority of major medicines regulators in Europe are now actively following up on missing drug trial results. We applaud their efforts to curb costly research waste and thereby safeguard the interests of patients and taxpayers. Going forward, three large gaps remain.”
“First, regulators in France, Italy, Spain and Sweden urgently have to take action on missing drug trial results before even more valuable medical evidence becomes irretrievably lost.”
“Second, regulators should develop action plans for how they will respond in 2023 or 2024 when the first trial result covered by the new European laws becomes overdue, in order to build a strong culture of compliance from the outset.”
“Third, political decision-makers across all countries should adopt new safeguards that protect patient and taxpayer interests, follow the UK’s positive example. In all countries surveyed, it remains completely legal to not make the results of many trials public. This legal vacuum perpetuates costly research waste. National regulators have told us that they cannot take action on these trials due to lack of relevant legislation."
Background
A vast body of research shows that many clinical trial results are never made public, or are only made public after a delay of several years. This harms patients, undermines public health, slows down medical progress, and wastes public money.
During the first half of 2022, the legal landscape for clinical trials in the European Union was transformed as two separate European regulations became fully applicable and therefore legally binding in all EU Member States:
Clinical Trial Regulation
Medical Devices Regulation
Responsibility for enforcing these new regulations lies with national regulators within each EU Member State.
In other words, the actions of national regulators will largely determine whether the new transparency rules on paper are effectively translated into better clinical trial reporting in practice. The new transparency rules have strong potential to benefit patients, but these benefits will only become reality if national regulators take effective action.
Today’s report is jointly published by nine patient and health groups from across Europe:
BUKO Pharma-Kampagne
Cochrane Austria
Consilium Scientific
Health Action International
Melanoma Patient Network
Salud por Derecho
Transparency International Global Health
TranspariMED
Universities Allies for Essential Medicines Europe
Regulators in France (ANSM), Italy (AIFA) and Spain (AEMPS) did not respond to TranspariMED's outreach.
The full report can be downloaded here:
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