National medicines regulators across Europe fail to protect patient interests – new report
National medicines regulators across Europe are failing to ensure that potentially life-saving data on medicines is rapidly and consistently made public, a new report warns.
Among the large regulators, CCMO (Netherlands) performs worst: only 10% of Dutch single-country trials approved up to 2015 currently have results available on the registry. Regulators ANSM (France) and AIFA (Italy) also perform exceptionally weakly, with a reporting rate of just 17%. In contrast, Latvia’s regulator boasts a reporting rate of 73% for such trials.
In addition, many national regulators have left the registry riddled with inaccurate and missing data, making it impossible to reliably determine which treatments and vaccines are currently being tested in trials, and how far individual trials have progressed. An analysis of a sub-set of trials shows that only 49% of protocols were made publicly visible on the registry in the first place by ANSM, the French regulator.
National regulators are responsible for ensuring that pharmaceutical companies, universities and hospitals running clinical trials within their countries make trial results public on the European trial registry within 12 months of completing a trial.
However, many national regulators are not even contacting trial sponsors that break the rules. Thousands of trial results are currently missing on the registry, slowing down medical progress and leaving gaps in the medical evidence base that harm patients, undermine public health, and waste public research funds.
In Italy alone, an estimated 1,221 single-country trials approved by AIFA up to 2015 are missing results in violation of European transparency rules. Inaction by national regulators has also led to large numbers of missing results in Spain (884), the Netherlands (839), France (698) and Germany (554).
Note: The estimates above are highly conservative and include only single-country trials where regulatory responsibility can clearly be assigned to a single national regulator. The overall numbers of missing results for each country are significantly higher.
The report calls on national regulators across Europe to take three steps:
Contact all sponsors of completed trials for which results are overdue
Review sponsors’ results disclosure compliance during pharmacovigilance inspections
Systematically update the completion status of all clinical trials
National regulators could take these steps unilaterally, without waiting for the outcomes of ongoing discussions on the European level about how to improve clinical trial reporting across the continent.
The report is based on a preprint by Nicholas DeVito and Ben Goldacre of the University of Oxford, plus additional data analysis by DeVito. The report is published jointly by four nonprofit groups: Health Action International, Melanoma Patient Network Europe, Transparency International France, and TranspariMED. Download the full report here:
Reactions by experts and civil society groups
Nicholas DeVito, a researcher at the EBM DataLab at the University of Oxford who compiled and analysed the data used in the report, said:
“This is the first comprehensive analysis of where data quality issues are occurring on the European trial registry. The registry should be a valuable resource for understanding clinical trials throughout Europe, but we are often left not knowing if a trial occurred, when it completed, or whether there are any results available for that trial. This utility of the registry is severely compromised by these issues.”
Till Bruckner, founder of TranspariMED, said:
“Many national regulators across Europe do not even contact pharmaceutical companies and universities that are breaking the rules, let alone fine them. Regulators’ neglect has resulted in long delays in the publication of clinical trial results and costly research waste. Patients who are desperately waiting for new and better treatments for Covid, cancer, and other potentially life-threatening diseases deserve better. Regulators must stop turning a blind eye and immediately take action to ensure that all missing clinical trial results are made public as rapidly as possible, especially as many trials of Covid medicines are due to report their results later this year.”
Natalie Rhodes, Policy Officer, Transparency International Global Health, said:
“Despite falling within the same policy landscape this research highlights the hugely, and worryingly, varying level of compliance with clinical trial transparency standards between European countries. This report paints a stark picture and highlights the clear need for transparency to be taken much more seriously by researchers, clinical trial sponsors, and regulatory agencies across Europe. Whilst much progress has been made in this area there is clearly much more that needs to be done.”
Ellie White, EU Projects Policy Advisor at Health Action International, said:
“This timely new report indicates systemic under-reporting of clinical trial data by medicines regulators across Europe, but it is important to remember that transparency is not a goal in itself. Without proper adherence to the European Union's existing transparency rules, through national implementation, and without information being consistently and systematically made public in a comprehensible way, we cannot expect researchers and public office holders make use of available data and thereby avoid the risk of research waste and other inefficiencies. This report sets out simple and achievable policy recommendations that we hope national regulators and other stakeholders will heed.”
Karla Soares-Weiser, Editor in Chief of the Cochrane Library, said:
"Cochrane is a strong supporter of efforts to ensure that data from all clinical trials are available. To assess a health care intervention's effectiveness and safety, we need to know what studies were done, how they were conducted and what they found. It is concerning to see from this new analysis that several of the national medicines agencies in Europe are not fully carrying out their duty to ensure that this information is publicly available. We urge them to take action to address this as soon as possible."
Patrick Lefas, Chairman of Transparency International France, said:
"Transparency International France hopes that in the interest of medical research and the well-being of patients, the [French national regulator] ANSM will adopt, as it has committed to do, a more active attitude towards public and private clinical trial sponsors to encourage them to comply with their transparency obligations. Otherwise, European legal obligations, even the most ambitious ones, will remain statements of intent."