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International Clinical Trials

Then and Now

As I write, the world is celebrating the 50th anniversary of the first human landing on the moon. Let’s look back at some of the things that were in effect back then. The EU was the EEC, just six countries, but the Council Directive 65/65/EEC had been introduced in the wake of the thalidomide disaster. This was about detailed marketing authorisation requirements across the European community. It took another five years, until 1970, for the directive to be incorporated into the national laws of each member state of the then EEC. There was no clinical trials directive, so there was no real legislative control on clinical trials, although the Helsinki Declaration had been set in 1964 to avoid unethical and unsafe clinical trials and for safe and proper treatment of human subjects.

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Dr Graham Hughes
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