EUdraCT information day 1
Posted by Andrew Smith on April 30, 2009
I’ve just returned from an information day at the EMEA, bringing together representatives of national Competent Authorities (CAs), pharma companies, CROs and non-profit stakeholder groups.
The purpose of the day was to communicate the features and development timelines of the next few versions of the EUdraCT database of clinical trials in the European Economic Area (EEA). These developments stem from EU Regulations 726/2004 and 1901/2006, which require certain information about clinical trials to be made available to the public.
Version 7 provides improvements to current function (ie, for sponsors to prepare information to submit to CAs) and is planned to go live on June 18th 2009. Version 8 is centred around making protocol information available to the public, and should be live in November 2009, while version 9 will publish information on the results of studies and is in early development, aiming towards the middle of 2010 for launch.
The first section of the day introduced the legal background and gave some statistics on the growth of EUdraCT since its launch in 2004. To date, nearly 40,000 applications have been logged, corresponding to just over 19,000 studies. Of these, nearly 80% are commercially sponsored, 65% are multi-site, 60% include sites in multiple member states and 50% also includes sites outside the EEA.
Fergus Sweeney of the EMEA stated that for the current year he expects the EMEA to receive around 10,000 applications, that will equate to around 5,000 new trials.
The meeting was chaired by Fergus Sweeney and Brian Davis of the EMEA, with Fergus and IT Analyst Neil Cordwell giving the presentations.
The next two posts will contain more details about v7 and the future versions v8 and v9, respectively.
At the time of writing, screenshots have been requested, with the intention of appending them to this post when received. It is also intended to publish aspects of this report in CRfocus magazine, hopefully in the July issue.
