Report | July 2021 | Download PDF
NOTE: A follow-up to this report was published on 3 October 2022
The report, Missing clinical trial data in Europe: Assessing and comparing the performance of national medicines agencies, based on data collected by researchers at the University of Oxford, shows that national medicines regulators in 14 key European* countries are failing to ensure that potentially life-saving data on new medicines and vaccines is rapidly and consistently made public as required by long-standing European Union transparency rules.
While numerous previous TranspariMED reports have assessed the extent to which companies and institutions follow European transparency rules, this is the first-ever report to assess to what degree national medicines regulators themselves follow and enforce the rules that they are responsible for upholding.
Key findings
This report documents that many national medicines regulators in Europe fail to:
- Make clinical trial registrations visible. The protocols for 1,207 drug trials approved by the regulator in France and 831 drug trials overseen by the regulator in Poland remain invisible on the European trial registry.
- Ensure that results of
trials are rapidly made public:
- 90% of older single-country trials approved by the regulator in the Netherlands do not have results available on the registry. Regulators in France, Italy, Finland, Sweden, and Spain also frequently fail to ensure that results are made public in line with European transparency rules.
- At least 5,976 clinical trial results are missing across the 14 countries. The largest gaps are in Italy (1,221 results missing), followed by Spain (884), the Netherlands (839), France (698) and Germany (554).
- Keep data on trials up to date. Weak data management by regulators has left the European registry riddled with inaccurate and missing data. National regulators in the Netherlands, Belgium, Italy and Spain are exceptionally negligent in this regard; only the UK and Poland perform well.
Policy recommendations
Each national medicines regulator in Europe can and should immediately and unilaterally initiate three simple, low-cost steps to improve the medical evidence base and safeguard patients’ and taxpayers’ interests,asrecommended by 18 health and patient groups from across Europe:
1. Contact all sponsors of completed trials for which results are overdue
2. Review sponsors’ results disclosure compliance during pharmacovigilance inspections
3. Systematically update the completion status of all clinical trials
*The UK left the European Union in January 2021, after the data underlying this report had been collected. This report nonetheless includes UK data because it sometimes provides a useful benchmark against which other regulators’ performance can be measured.