Introduction

Clinical trials can be classified as:

♦ Phase II studies

♦ Phase III studies

In addition, some Phase III studies are sometimes referred to as Phase IV or post-marketing studies.

No study should be started without a protocol that describes in detail:

♦ Patient eligibility criteria

♦ Screening and follow-up studies

♦ Criteria to score toxicity and activity

In addition, rules for informed consent procedures should be specified.

All of these criteria have been specified in guidelines produced by the International Conference for Harmonisation for Good Clinical Practice (ICH-GCP).

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