Thursday, March 24, 2011

The European Union Launches Its Version Of ClinicalTrials.Gov -- Huzzah!


This is a deeply gratifying development -- now almost all EU clinical trials (or at least those under which at least one of the sponsor's aims is to obtain an EMEA approval for some drug or indication) will be summarized, and tracked, online, in much the same fashion as the ClinicalTrials.Gov site does, here in the United States. Additionally, studies involving pediatric indications or pediatric drugs will be tracked, even if not EU-based and EMEA-driven. Excellent.

Do go take a look around at the shiny new EU site -- it is quite a leap forward. However, you'll need to contact Merck's EU sub, called MSD directly, if you'd like a complete list of all its EU-based clinical trials, in the aggregate, as that database search capbility is not yet available on the EU site. From the presser, then:

. . . .From today, all EU citizens will have access to information on the thousands of authorised pharmaceutical clinical trials that are underway in the EU. The aim of this official public register is to make clinical research on pharmaceuticals more transparent for patients and others and to avoid unnecessary duplication of clinical trials. Every year approximately 4000 clinical trials are authorised in the EU. Since most of them last 2 to 3 years, this means that around 10 000 trials are ongoing at any given time. . . .

The EU Clinical Trials Register website allows you to search for information on clinical trials in European Union (EU) member states and the European Economic Area (EEA) and clinical trials which are conducted outside the EU/EEA if they form part of a paediatric investigation plan (PIP). . . .

This is a very welcome addition to the pharma practicioners' online tool-kit -- it should make life much easier for all of us practicing in this arena.

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