Look ahead to EUdraCT v8 and v9
Posted by Andrew Smith on April 30, 2009
This meeting at the EMEA earlier today concluded with a look ahead to future versions of EUdraCT, which will enable protocol summaries and results of clinical trials to be made available to the general public, in accordance with EU Regulations 726/2004 and 1901/2006. These will be done in v8 and v9 respectively.
Guidelines for the data fields to be published were finalised in July 2008 and February 2009 respectively.
Version 8 is intended to complete internal testing on September 1st 2009, with user testing in November to go live on November 30th 2009. It will make public specific fields from the protocol information as soon as a CA/REC decision has been input (ie, trials withdrawn before a decision will not be published), as initially entered (ie, mainly in English, although the coded terminology could be translated in the future). Data will still be entered to the database by the CAs with no direct sponsor access, although direct electronic submission by sponsors is being considered for a future version, as is ongoing maintenance of specific data items (eg, public contact point etc.).
Studies added from launch will be immediately available to the public, with a gradual backfill of older studies, although information not in the original submission will not be collected retrospectively, such as the public contact point that will be required from this version onwards.
The new data fields for public accessibility have been published by the EC.
For sponsors using the system, it will move from a wizard system to being more menu based, to enable use of modern smart form logic to hide un-needed questions, collection additional information if required, enable re-use of core sponsor details between studies etc.
To accomodate all of this, a substantial change will be made to the underlying database structure, and to the XML schema. This will have significant implications for sponsors and national systems (eg, IRAS) which interact directly with this dataset. Drafts will be circulated as soon as possible so other systems can be updated accordingly.
The other major change in v8 extends all of this functionality to accomodate paediatric studies being conducted in 3rd countries (ie, outside the EEA) but which are included in a Paediatric Investigation Plan (PIP).
Looking further ahead to v9, which is intended for user testing and launch around September 2010, this will make available information about the results of studies to the public. The details of this (ie, what level of summary/specifics) are still under discussion, although there is a desire to harmonise with similar initiatives outside the EU.
The regulations state that information on paediatric studies will be made public 6 months after completion of the study, with adult studies from Phase II onwards being published 12 months after completion (the regulation does not differentiate between Phase I studies with healthy volunteers and those with patients).
The programme of development to take EUdraCT from its current v6 to v9 over the next 18 months represents a significant amount of work, and a significant expansion of the usability and value of the EUdraCT system, to Competent Authorities, sponsors and the general public alike.
A further meeting is planned for Autumn 2009 to discuss the ongoing development and intended launch of v8, and we will continue to watch and report on this important area of development for clinical research being conducted in Europe.
