Europe proposes laxer regulation of clinical trials

Cmaj.ca: September 25, 2012

The culprit is an 11-year-old creature known as the European Commission’s Clinical Trials Directive that apparently creates a mountain of bureaucratic red tape and overly-stringent oversight leading to an average 152-day delay in the start of trials.

The consequence, many companies and researchers say, has been a substantial decline in the number of applications to conduct clinical trials in the European Union — to 3800 in 2011 from 5028 in 2007 — as companies bailed for countries in which the rules are more industry-friendly. Read more