European Parliament Approves Clinical Trials Legislation
The public health committee of the European Parliament (EP) has approved EU draft legislation that will require pharmaceutical producers and researchers to upload all results of clinical trials to a publicly accessible database. The legislation will be debated and voted in the plenary session at the beginning of April.
Designed to encourage research but at the same time protect patients' rights, the new legislation would replace an existing directive with what the EU termed "simpler, more uniform, rules." These make specific provision for low-intervention trials, clarify the role of ethics committees in the authorization process and provide details on how to obtain informed consent from patients.
The EU said the idea behind the changes is to improve transparency and streamline the rules on clinical trials across Europe, thereby facilitating cross-border cooperation to enable larger, more reliable trials, including those on drugs to treat rare diseases.
One of the most important new provisions, along with simpler reporting procedures, is the empowerment of the European Commission to perform checks. Once a clinical trial sponsor has submitted an application dossier to a member state, the member would have to respond within fixed deadlines.
The European Parliament said it had amended the original legislation to require detailed summaries to be published in the database, with full clinical study reports published once a decision on marketing authorization for the tested product is complete or the application withdrawn. Fine would be imposed on sponsors who do not comply.
"Around half of all trials are never published, the EP said, "especially those with negative or disappointing results."
