Clinical trials for medicines in Europe are tightly regulated. The current system, introduced in 2001 under the Clinical Trials Directive, has been criticised for being too onerous and costly. The proposed new Clinical Trials Regulation is intended to cut red tape and make it easier for pharmaceutical companies to conduct multinational clinical trials.
Because the current rules were introduced by Directive, they had to be implemented by each country individually to become operational. Although a Directive sets out uniform rules, it allows some flexibility in how member states give effect to them. In contrast, a Regulation is an EU level instrument which takes effect without any need for national action and with no variability between countries.
A welcome introduction is the concept of ‘low-intervention clinical trials’. These will impose a lighter regulatory burden on trials which are seen as exposing subjects to lower risk; an example being the comparison of already approved medicines.
One area that has received much attention from policy-makers and the media is transparency. The new rules will make it compulsory to publish all clinical trials, including those that do not support use of the medicine.
The Regulation has recently been finalised, although it cannot take effect until the new EU Portal for central submission of data is up and running. This is expected to take until mid 2016.
The EMA is already releasing documents submitted as part of applications for EU marketing authorisations in response to requests. It claims to have made public nearly 2 million pages of data from November 2010 to April 2013 alone. The system allows for redaction to protect personal data or commercially sensitive information, although at least two companies have brought proceedings against the EMA for giving access to clinical data.
The EMA is now aiming for proactive publication of clinical trial data once the decision on whether to grant an EU marketing authorisation is made. A consultation launched last summer received a wide range of comments and the EMA has been refining its approach. The policy is due to be finalised in June this year.
Many pharma companies are now embracing transparency. Astra Zeneca's global policy is one example. A sensible approach now that it is becoming inevitable.