Regulatory Focus™ > News Articles > EU Clinical Trials Directive Leading to Dramatic Decline in Clinical Trials, Says UK Cancer Charity

EU Clinical Trials Directive Leading to Dramatic Decline in Clinical Trials, Says UK Cancer Charity

Posted 13 February 2012 | By Alexander Gaffney, RAC 

The EU Clinical Trials Directive has almost doubled the cost of clinical trials while leading to a 66% drop in clinical trials in the United Kingdom, reports The Telegraph.

The Telegraph spoke to the Chief Clinician of the advocacy group Cancer Research UK (CRUK), Professor Peter Johnson, who said that "the directive has just about doubled our costs for maintaining a portfolio of trials, because the cost of manpower pretty much doubled." This has a particularly pernicious effect on the charity, which depends on donations to conduct its clinical trials research.

The "regulatory burden" of conducting research under the new directive has already led to CRUK axing a clinical trial, said Johnson. CRUK, along with 15 other charities, are calling for the CTD to be revised to be more risk-proportionate.

"I think there's such a broad consensus of the difficulties that have been generated by the directive - among researchers and patients and politicians - that I think there's a very good chance that we will see the directive substantially amended," said Johnson.



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