The European Medicines Agency (EMA) recently announced that it is now mandatory for sponsors to post clinical trial results in the European Clinical Trials Database (EudraCT), the application used by national competent authorities to enter clinical trial data, managed by the European Medicines Agency (EMA). Trial results information will be publicly available via the EU Clinical Trials Register including summary results from sponsors. This will apply both to clinical trials in progress, and past clinical trials. Given the amount of information to be entered in the database, clinical trial results will be uploaded progressively:
For clinical trials ending on or after 21 July 2014, sponsors have to post results within six or twelve months, depending on the type of trial;
For trials that ended before that date, sponsors will need to submit the results retrospectively, which may represent some delays.
The EU Clinical Trials Register is the publically available database of information extracted from EudraCT. Since it launched in 2011, the EU Clinical Trials Register has consistently improved and expanded services to allow greater public access to information on clinical trials in the EU. Recent improvements include the ability to search for clinical trials with or without results and the latest move to view results provided by trial sponsors. There is also now more information available on paediatric clinical trials conducted in the European Union (EU) and European Economic Area (EEA) as well as information on paediatric trials of products with an EU marketing authorisation, even when the trial sites are outside of the EU/EEA.
Bigger changes afoot
There are even bigger changes in store for the EU Clinical Trials Register. The new European Regulation on Clinical Trials was published in the Official Journal of the European Union on 27th May following a long period negotiation and revision. The new Regulation is expected to make multinational clinical trials easier to conduct, easing procedures for cross-border collaboration, which is especially significant for rare disease research. The new Regulation specifies that the European Medicines Agency (EMA) has the responsibility for developing information technology platforms to support clinical trial sponsors and experts in the EU. Thus the EU Clinical Trials Register will become part of a larger EU portal that will be a comprehensive repository for ongoing and finished clinical trial information. EURORDIS is involved in this project in an advisory role and will ascertain that the new portal is patient-friendly and accessible. The EU portal is expected to launch in 2016.
EU Clinical Trials Register rare disease search option
The EU Clinical Trials Register offers several interesting features, including a "rare disease" advanced search engine feature that permits users to search for protocol and results information on interventional clinical trials conducted in the EU/EEA. Searches can be refined by disease, medicine, participant age, phase or status of trial, country and date.