Joint Report* | October 2022 | Download PDF
This report assesses to what degree national medicines regulators themselves follow and enforce the clinical trial data rules that they are responsible for upholding.
The report is based on data scraped from the European clinical trial registry. It assesses the status quo of national regulator performance as of July 2022, and tracks their progress since December 2020. The report shows that national medicines regulators in several key European countries are failing to ensure that potentially life-saving data on new medicines and vaccines are rapidly and consistently made public as required by long-standing European Union transparency rules.
Why this matters
Unreported clinical trials leave gaps in the medical evidence base that harm patients, undermine public health, and lead to public funding being wasted. National medicines regulators are responsible for overseeing drug trials involving their own national citizens and ensuring that these adhere to existing laws, regulations and guidelines.
Key findings
- Missing trial results. National medicines regulators in Europe have failed to ensure the publication of at least 5,488 clinical trial results for which they are unambiguously responsible. The largest reporting gap by far is in Italy, where an estimated 1,299 results are missing. Four countries – Italy, the Netherlands, Spain and France between them account for over two thirds of missing clinical trial results.
- Mixed progress in absolute terms. National regulators in four countries – Germany, Austria, Denmark and Belgium – have succeeded in considerably reducing the number of missing trial results. In contrast, the number of missing results has further grown in Italy and France.
- Improvements in reporting rates. Strong engagement by the European Medicines Agency at the central level has boosted trial reporting rates across all countries since 2020. Parallel engagement by national regulators has led to high reporting rates in Germany and Austria, and substantial progress in Denmark and Belgium. Progress in other countries is more limited, suggesting little or no engagement by their national regulators.
Recommendation
National regulators must act now. The remarkable progress made by some countries between 2020 and 2022 clearly shows that strong engagement by national regulators can drive substantial improvements in clinical trial reporting. For example, Austria improved its reporting rate from 26% to 65% within less than two years. National regulators whose countries are currently lagging behind should rapidly roll out successful approaches used by their peers before countless clinical trial results become lost forever. This is not only an ethical and scientific imperative, but also far more cost-effective than having to re-run the same trials again several years down the line.
*Joint report with TranspariMED, Cochrane Austria, Transparency International, Salud por Derecho, Concillium Scientific, Melanoma Patient Network Europe, Buko Pharma-Kampagne and Universities Allied for Essential Medicines.
NOTE: This paper is a follow-up to a report published in July 2021.