European regulators fire warning shot over 5,855 missing clinical trial results
In a warning shot, the European Commission, the European Medicines Agency, and the Heads of [National] Medicines Agencies have issued a joint letter reminding clinical trial sponsors across Europe of their obligation to make medical research results public.
Making the results of all clinical trials available on the European registry will “allow patients, practitioners, policy makers and other economic operators to make well-informed decisions about health-care and medical research,” the letter points out.
According to the European Medicines Agency (EMA), 5,855 clinical trials, or 31.8% of all verifiably due trials, remain in breach of reporting requirements that have been on the books since 2014.
This includes more than one in five trials (22.8%) run by pharmaceutical companies, and over three quarters (76.4%) of trials run by universities, charities, and other non-commercial sponsors.
The European Union is currently ramping up efforts to promote compliance.
For example, since September 2018, the EMA has been identifying trials with missing results on a monthly basis and sending out reminders to the institutions sponsoring them.
Many large companies and some leading universities already have impressive transparency records, illustrating that full compliance is possible. For example, 100% of due trials run by Pfizer have already posted results, as have over 98% of due trials sponsored by the University of Dundee in Scotland.
Founder of TranspariMED, Till Bruckner, said:
“This European effort to promote voluntary compliance is good news for patients and taxpayers. It is especially encouraging to see that the Heads of Medicines Agencies, representing all national regulators across the EU, have co-signed the letter. Now the ball is in the court of Europe’s national governments. They alone have the power to impose sanctions on companies and universities that continue to violate long-standing transparency rules. Governments need to finally stand up for patients’ interests and end impunity in the medical research sector, once and for all.”
In a press release, the EMA highlighted that failing to post clinical trial results harms patients, undermines public health, and wastes taxpayers’ money:
“Transparency and public access to clinical trial results, whether positive or negative, are fundamental for the protection and promotion of public health. It assures trial subjects that their voluntary participation in clinical trials is useful and that the results have been collated and reported for the benefit of all… [I]t allows patients and healthcare professionals, or any other citizen, to find out more information about medicines they might be taking or prescribing. Transparency also enhances scientific knowledge and helps to advance clinical research and support more efficient medicine development programmes.”
The figures for unreported trials cited by the EMA are likely to substantially underestimate the true extent of the problem, as national medicines regulators across Europe have failed to keep registry entries up to date. The UK regulator, MHRA, has begun clearing its own backlog, but it is unclear whether other regulators in Europe are doing the same.
Click here to read the European joint letter – which includes links to multiple tools and resources –and the EMA press release.
To see how your own institution is performing, check the EU Trials Tracker. Universities can use TranspariMED’s collection of transparency tools to improve their policies, processes and performance.