Abstract

Running clinical trials in the commercial sector has always been associated with a certain amount of bureaucracy due to the stringent requirements needed to bring a new drug onto the market. Noncommercial trials have largely been performed outside these requirements. New legislation brought about as a result of the implementation of the European Union Clinical Trials Directive will change this two-tiered approach by harmonizing regulations in all member states. Those who run noncommercial clinical trials will have to find cost-effective ways of dealing with this legislation if such work is to continue in Europe.

Highlights

  • In History and Advancement of Anastrozole in the Treatment of Breast Cancer

  • The directive that sets a time limit on research ethics committees is Directive 2001/20/EC [2], entitled the Clinical Trials Directive (CTD), which aims to harmonize the administration of clinical trials throughout the European Union (EU)

  • The CTD has a wide scope, and covers many aspects of the conduct of clinical trials in the EU on human subjects that involve a medicinal product

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Summary

Introduction

In History and Advancement of Anastrozole in the Treatment of Breast Cancer. Edited by Buzdar A, Baum M. Performing clinical trials can be frustrating at times, and one of the most exasperating tasks is corresponding with local research ethics committees.

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