European Medicines Agency launches a new version of EudraCT-European Clinical Trials Database. Summary results of clinical trials soon to be available to the public.
The European Medicines Agency has launched a new version of the European Clinical Trials Database (EudraCT). This new version, EudraCT V9, marks the initial step of a process through which summary clinical trial results will be made publicly available through the EU Clinical Trials Register (EU CTR).
EudraCT is a database used by national competent authorities to enter protocol-related information on clinical trials submitted by clinical trial sponsors, but also includes protocol-related information on clinical trials in third countries if they are included in a PIP. The database is hosted by the European Medicines Agency.
A subset of this data is made available through the EU Clinical Trials Register which the Agency manages on behalf of the EU.
Users are able to view the description of phase-II to phase-IV adult clinical trials where the investigator sites are in the EEA, as well as any clinical trials in children with investigator sites in the EU and any trials that form part of a PIP, including those where the investigator sites are outside the EU.
This new feature of EudraCT is another step towards increasing clinical trialtransparency in Europe and will allow sponsors to provide summary results of all interventional trials already published in the EU CTR.
In comparison to the www.clinicaltrials.gov website, its American international counterpart, it is not so easy to use and get detailed information. The European Cancer Patient Coalition, in its response of 2008 to a public consultation for data fields from EUDRACT to be made public, pleaded for the adoption of “all WHO Guidelines requiring 20Key data sets to be published” and “recommended that details on the trial sites should be mandated in the Guidelines for EudraPharm along WHO policy lines”.