EU nations approve law to overhaul clinical trialsBMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f7682 (Published 23 December 2013) Cite this as: BMJ 2013;347:f7682
European Union governments have given their support to pan-European legislation that would speed up authorisation procedures for clinical trials and ensure that all trials were registered in a central database and their results made publicly available.
The new measures, which had been politically agreed by governments and the European Parliament in the second week of December, will replace rules that have operated since 2001 with simpler, more uniform requirements. The current rules have been widely criticised for being excessively bureaucratic, leading to a sharp decline in the European Union in trials of drugs for humans. In 2007 the number of such trials was 5000. Four years later it was 3800.1
The new legislation makes specific provision for “low intervention trials” (those that pose only minimal risk to safety of participants in comparison with normal clinical practice), clarifies the role of ethics committees in the authorisation process, strengthens rules on the protection of patients, and gives details of how to obtain informed consent.
Compulsory prior registration of all EU trials on the publicly accessible EU portal will bring more transparency to the conduct and results of clinical trials. Detailed summaries must be published once marketing authorisation for the tested drug is complete. Sponsors who fail to comply with these requirements face fines.
The development was warmly welcomed by the British Labour member of the European Parliament Glenis Willmott, who steered the legislation through the parliament.
She said, “For too long, unflattering studies on new medicines have gone undisclosed. Around half of all trials are never published, usually those with negative or disappointing results. It is vital we know about negative outcomes.”
A single authorisation procedure will speed up assessments of applications to conduct trials. The new rules set a 60 day deadline for authorisation of trials and one of 49 days for responding to substantial modifications of a trial. In each case, if no response is given within that period, approval will be deemed to have been given, providing more legal certainty to sponsors and researchers.
The successful progress of the new legislation was widely welcomed. The European Federation of Pharmaceutical Industries and Associations, which represents the drug industry in Europe, noted that the new framework would allow for “a more harmonised approach with a single submission, streamlined assessment, and reduction of red tape,” helping to restore European competitiveness in clinical research.
The campaigning group Sense about Science called for results of previous studies to be published. Síle Lane, the organisation’s director of campaigns, said, “There is no excuse for not publishing results but a huge public benefit to having a complete picture of what was found in trials conducted on treatments currently available to patients.”
Mark Wilson, chief executive officer of the Cochrane Collaboration, described the outcome as “a victory for patients, practitioners, and policy makers across Europe.”
In a formality, the legislation must be officially endorsed by EU governments and the European Parliament in the coming months before entering into force in 2016.
Cite this as: BMJ 2013;347:f7682