AHLA Connections

Authors: Maria Wall

Current Situation in Europe

A draft report by the European Parliament (EP) on January 31, 2013 stated that one of the major problems at the moment with the regulation and performance of clinical trials in Europe is the lack of transparency of clinical trial results.

The report concluded that this lack of transparency has reduced public trust in trials and their findings, stating:

Independent academics often find it difficult to get the data they need to verify the results of trials and carry out systematic reviews, and a lot of data is withheld. It is also known that when trials are unsuccessful the results are often never published or made available at all. Trials can be carried out repeatedly before it becomes public knowledge that they are ineffective or even dangerous.

Current Regulation in Europe

Directive 2001/20/EC on the approximation of laws, regulations, and administrative provisions of member states relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (the Directive) was implemented to (1) standardize research activity in clinical trials (2) harmonize the regulation and framework of clinical trials among member states of the European Union (EU) and (3) provide greater protection for clinical trial subjects.

Download the .PDF below to read the full article.


Copyright 2013 American Health Lawyers Association, Washington, DC. Reprint permission granted.