New European legislation on clinical trials is published

Clinical trials in Europe should be simpler to set up and more transparent in reporting their results, after a new European Union regulation1 that sets the clock ticking for the recommendations to become law in all member states in 2016.

The regulation replaced the previous Clinical Trials Directive, introduced in 2001, which many people have blamed for a substantial decrease in clinical trials in the EU over the past decade.

A notable change was the introduction of a centralised system for approving clinical trials, meaning that researchers who run trials in several countries need apply only once for approval, to a portal set up by the European Medicines Agency. Previously, researchers had to apply separately to each country included in a multinational trial.

Michael Rawlins, president of the Royal Society of Medicine and the author of a report on UK clinical trial governance that was highly critical of the old directive,2 said that the new legislation should streamline the approval of clinical trials.

“I hope it will make clinical trials easier but still ensure appropriate arrangements for patient safety. It should reduce some of the unnecessary bureaucracy associated with the old Clinical Trials Directive, especially for non-commercial studies,” he said.

However, he was concerned about whether the single application system would work in practice. “The EU does not have a great track record in this area,” he cautioned, explaining that considerable scope for differences in interpretation still existed between countries because of “linguistic challenges.”

The new regulation aims to increase transparency by requiring the publication of results, including negative findings. All trials in the EU must be registered on a publicly accessible clinical trials database established by the European Medicines Agency as part of the central portal. A summary of results must be uploaded within one year of a trial ending, and the full study reports must be uploaded if a medicine is submitted for marketing authorisation.

“Currently, around half of all clinical trials are not published, which is unacceptable,” warned Glenis Willmott, member of the European Parliament for the East Midlands and the rapporteur for the new clinical trials regulation. “This can lead to unnecessary or dangerous trials being repeated and can give a biased picture of the safety and efficacy of the medicines we are prescribed.

“Finally, patients, doctors, and researchers will have access to the results of all clinical trials—positive, negative, and inconclusive. That’s good for patient safety, good for scientific progress, and good for public trust in medicines,” she said. The regulation stated that clinical study reports should not be seen as commercially confidential, which Willmott considered would be important in supporting efforts by the European Medicines Agency to publish data that it held on old trials.

Another change is that the new regulation will enable data collected in a clinical trial to be used in further research after the study has ended. Clinical trial participants will be able to give “one time” consent for data to be used for research beyond the trial, rather than researchers having to gain further consent to use data in subsequent studies.

“The concept of a one time consent is an essential component of successful medical research,” said Rolf Stahel, president of the European Society for Medical Oncology. “Its inclusion in the new clinical trials regulation is a welcomed recognition of its importance for the medical community at large.”