Clinical Trial Registry – European Union (EUDRACT)

Posted on Updated on


Learn Clinical Research with AuroBlog

Clinical Trial Registry – European Union.

The EU Clinical Trials Register contains information on interventional clinical trials on medicines conducted in the European Union (EU), or the European Economic Area (EEA) which started after 1 May 2004.

Clinical trials conducted outside the EU/EEA are included if:

  • They form part of a paediatric investigation plan (PIP), or:
  • They are sponsored by a marketing authorisation holder, and involve the use of a medicine in the paediatric population as part of an EU marketing authorisation.

The Register also provides information about older paediatric trials covered by an EU marketing authorisation.

The Register enables you to search for information in the EudraCT database . This is the database used by national medicines regulators for data related to clinical trial protocols. The data on the results of these trials are entered into the database by the sponsors themselves and are published in this Register once the sponsors have validated the data.

The EU clinical trials register has been a primary registry in the World Health Organization (WHO’s) Registry Network since September 2011 and is a WHO Registry Network data provider. It is also available on the WHO International Clinical Trials Registry Platform 

In this Register, you are able to:

  • view the description of phase II to phase IV adult clinical trials where the investigator sites are in the EU/EEA;
  • view the description of any paediatric clinical trial with investigator sites in the EU/EEA;
  • view the description of any paediatric clinical trial that is sponsored by a marketing authorisation holder and involves the use of a medicinal product covered by an EU marketing authorisation in the paediatric population including trials conducted outside the EU / EEA;
  • view the description of any trials which form part of an agreed paediatric investigation plan (PIP) including those where the investigator sites are outside the EU/EEA;
  • view the summary results of the the clinical trials mentioned above;
  • view the summary results (with a reduced set of data fields) of paediatric trials completed by 26 January 2007 covered by an EU marketing authorisation;
  • download up to 50 results (per request) in a text file (.txt).

The details in the protocol related information include: the design of the trial; the sponsor; the investigational medicine (trade name or active substance); the therapeutic areas; the status (authorised, ongoing or complete).

The details of the information of the summary results for a trial include: trial information; subject disposition; baseline characteristics; endpoints; adverse events; additional information; summary attachment(s).

What is not available?

The EU Clinical Trials Register does not: provide information on non-interventional clinical trials of medicines (observational studies on authorised medicines);

provide information on clinical trials for surgical procedures, medical devices or psychotherapeutic procedures; 

like and comment, like, facebook

Advertisements

Let us know what you think!

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s