EMA seeks new input on trial regulation

The European Medicines Agency (EMA) has launched the public consultation on how the transparency rules of the European clinical trial regulation will be applied in the new database. Everybody has until 18 February 2015 to send their comments.

The regulation aims to create an environment that is favorable to conducting clinical trials in the European Union. EMA hopes it will ensure the rules for conducting clinical trials are consistent throughout the EU, and is keen to transform the level of information publicly available for each trial carried out in the EU by requiring transparency on the authorization, conduct, and results of the study. The regulation will apply to trials registered once the regulation is in operation (not before 28 May 2016).

The new clinical trial portal and database will be used for submission and maintenance of trial applications and authorizations, and will serve as the source of public information on the applications assessed and all trials conducted in the EU. EMA is responsible for the development and maintenance of the portal and database, while the authorization and oversight of clinical trials will remain with each member state.

The plan is for the public to access extensive details of each trial, including the characteristics, the start and end of recruitment, end date and substantial modifications. A summary of results and lay summary will be published 12 months after the end of the trial. For those trials included in a marketing authorization application in the EU, clinical study reports will also be published 30 days after the procedure for granting the authorization has been completed or the application has been withdrawn.

The regulation requires that the trial database shall be publicly available unless one or more of the following exceptions apply: protection of personal data; protection of commercially confidential information, in particular taking into account the marketing authorization status of the medicine, unless there is an overriding public interest; protection of confidential communication between Member States in the preparation of their assessment; protection of the supervision of clinical trials by Member States.

According to EMA, the document under consultation sets out proposals for the application of the transparency rules of the regulation for stakeholders to review and comment on. The proposals aim to balance the right of patients and the public to access extensive and timely information on clinical trials, and developers’  and researchers’ need to benefit from investments.

Stakeholders are asked to send comments to CTReg@ema.europa.eu by 18 February.

Read the full text here.