European health groups demand action on missing clinical trial results

Today, a coalition of 20 health groups from across Europe wrote to the European Medicines Agency calling for urgent action on weak compliance with the EU’s new clinical trial results reporting law.

In parallel, 19 health groups wrote to national medicines regulators in all 30 countries that use the European registry for clinical trials of medicines.

Half of trials are missing results

The campaign follows a recent study showing that half of drug trials in Europe did not have results available as required by law. The resulting evidence gaps threaten to harm patients and undermine public health.

By law, pharmaceutical companies, universities and hospitals running drug trials in Europe must make public both scientific results and layperson summary results on the CTIS registry, normally within a year of trial end. Regulators within each of the 30 countries are responsible for enforcing the law.

The study of CTIS results reporting found that of the first 234 European drug trials that were legally required to report results, only 116 had done so fully and on time. Another 20 trials reported results late. The remaining 98 trials had not fully reported results.

None of the major countries had a perfect compliance record. For example, the Spanish regulator AEMPS was responsible for ensuring that the results of 52 trials were made public, more than any other national medicines agency. Of those 52 trials, 11 had no results, 9 had a ‘results’ document that was missing key data, and 6 had published their results after the legal deadline.

Three questions for national regulators

The letters sent today ask national regulators three basic questions. What have they done to support voluntary compliance? What sanctions have they imposed, or do they plan to impose? And do they check whether uploaded results documents meet the minimum requirements set out by law?

In addition, the letters list the unreported trials that each regulator is responsible for. Here is part of the list for Spanish regulator AEMPS:

Note: Data accurate as of November 2025.

Till Bruckner, founder of TranspariMED, said:

“Patients deserve better than this. The status quo is completely unacceptable. Regulators cannot just let pharmaceutical companies upload PDF documents without checking whether they actually contain results.”

"This is a ticking time bomb. Over the coming months, the results of hundreds of additional clinical trials will come due. Unless regulators take action now, before they hit the beaches for their summer holidays, this problem will spin completely out of control.”

“Patients were promised that the new laws and the new registry would bring “high levels of transparency never seen before for clinical trials”. Regulators must turn that promise into reality now.”