Federation of European Cancer Societies
New European legislation impacts both cancer trials and drug approval
Published in Physician Law Weekly, November 23rd, 2005
Yet concerns were also voiced that the recently implemented Clinical Trials Directive is having a converse effect, restricting the number of new cancer trials carried out by impinging on the conduct of international, investigator-initiated, multicenter studies within Europe.
The aims of the Clinical Trials Directive are noble - to harmonize legal acts for the set-up, conduct and reporting of clinical trials, implement GCP-principles Europe-wide and enforce patient safety. Yet there are...
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Source: Physician Law Weekly (2005-11-23)
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