On 2 April 2014 the European Parliament approved a new regulation that will repeal Dir 2001/20/EC and reform the law regarding authorisation and running a clinical trial in the European Union. The new regulation aims to cure a number of deficiencies which have been the subject of substantial complaint, in the hope that this will result in a swifter and more transparent process but not at the expense of safety.
The main changes are:
- Streamlined application process – This will have a central applications portal for depositing information. Rather than have to apply to each Member State in which the trial will be held individually, as is the current system, a sponsor will have to submit a single dossier to the central portal. This will be considered by the designated Member States within strict timetables, with one “reporting” Member State taking the lead. Further Member States can be added later without the need for a full re-examination by all participating Member States.
- Streamlined reporting procedure – A central database for the storage of data and information submitted through the portal will be created. Reporting of the outcome of the clinical trial, the annual safety reports, and reports of any adverse reactions will be made through the portal and into the central database.
- Transparency and safety – As part of the reporting from the clinical trial, all unexpected events that might materially influence the benefit-risk assessment of the clinical trial must be reported. This is in addition to the serious adverse events and reactions that previously had to be reported. Further detailed summaries of the trial will have to be published on the central database, and will be accessible to the public.
- Flexibility of requirements for low risk trials – The regulation will permit flexibility in the informed consent, reporting, traceability and storage, insurance and monitoring requirements of the clinical trial dependent on the risks involved. In particular the regulation creates the concept of a “low intervention clinical trial”, being a trial which uses medicinal products that are already the subject of a marketing authorisation, that are being used in accordance with the marketing authorisation or in accordance with published scientific evidence on the safety and efficacy, and that only poses a minimal additional risk to the subjects.
- Co-sponsorship – Co-sponsorship by two or more sponsors will be possible. Co-sponsors will be able to delegate the responsibilities placed upon them by written contract. However this delegation will not remove the responsibility of each sponsor for the safety and reliability of the clinical trial.
- Insurance for damages – Member States will need to ensure that systems for compensation for damage suffered by subjects of the clinical trial are provided in the form of insurance, a guarantee or similar arrangement. This cover will not be necessary for low intervention clinical trials for which a compensation scheme already in place.
Whilst the regulation has been approved by the European Parliament it will not come into effect until 6 months after the systems for the portal and the database have been completed. This is likely to be some time in 2016, at which point it will be necessary to consider how patient consent forms and contracts between sponsors, participating centres and CROs will need to be adapted to accommodate the new regime.