EC proposes revision of Clinical Trials Directive

The European Commission (EC) is proposing to replace the Clinical Trials Directive, which came into force in 2001, after criticism from patients, researchers and the pharmaceutical industry about the high costs and a lack of harmonisation of the applicable rules necessary for multinational clinical trials.

The EC says this contributed to a 25% decline in clinical trials in the EU from 2007–2011. Five thousand clinical trials were applied for in 2007, falling to 3,800 by 2011.

The Commission is therefore proposing new legislation to ‘cut red-tape and bring patient-oriented research back to Europe’.

The main changes to the law include:

• A simplified authorisation procedure allowing for a fast and thorough assessment of the application by all Member States concerned and resulting in one single assessment outcome. This will allow the individual Member State to appoint the body or bodies in charge of the assessment, on the condition that the assessment is fully independent and based on the necessary expertise.
• Simplified reporting procedures, which spare researchers from submitting largely identical information on the clinical trial separately to various bodies and Member States.
• The possibility for the Commission to conduct controls in Member States and other countries to ensure the rules are being properly supervised and enforced.

The proposal, while continuing to uphold patient safety, takes better account of the actual risk the subjects will be exposed to during the clinical trial. It introduces the concept of a 'low-intervention clinical trial', i.e. a clinical trial where the additional risk for a patient compared with receiving a treatment in normal clinical practice is negligible. In these cases, the regulatory requirements will be less burdensome and the timeline for authorisations shorter.

It also includes rules for clinical trials conducted outside the EU but referred to in a clinical trial application within the EU. In these cases, the proposal provides for compliance with regulatory requirements at least equivalent to those in the EU, including rules on transparency.

The UK's BioIndustry Association welcomed the proposals, stating that a simplified and efficient regulatory framework for clinical trials is vital to improve Europe's attractiveness as a global location for clinical research and development of new medicines.

The organisation also said the changes would benefit all stakeholders in the European Union, allowing patients faster access to innovative treatments, while reducing the administrative burden and costs for public and private sector researchers as well as for EU Member States.

The proposal will be discussed in the European Parliament and in the Council. It is expected to come into effect in 2016.