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Detailed regulations need to be complied with during clinical trials. These are established in the European guidelines on Good Clinical Practise (GCP) and in the German Medical Preparations Act (Arzneimittelgesetz) and apply to the three phases.
First administration on humans
The clinical trials of potential active substances are divided into different phases. In phase I of the clinical trials, the substance is administered on humans for the first time in order to analyse its tolerability. In order to accomplish this, 60 to 80 healthy, voluntary test persons are given a small dose of the substance, which is slowly increased under strict supervision. This way, knowledge can be gathered on human pharmacology and tolerance of the substance.
In phase II of the clinical trials, the substance is administered on 100 to 500 patients suffering from the target disease. The analyses help to gain knowledge on effectiveness and tolerability of the substance when administered for a short period of time. In addition, different possible doses of the substance are examined systematically in this phase and compared to the standard therapy.
Phase III of the clinical trials is a broad examination with several thousand patients which represent the cross section of the patients to be treated later. In this phase, the therapeutic profile and the therapeutic benefit (in comparison with drugs already available on the market) are determined under practical conditions. The risk-benefit ratio as well as the interaction with other drugs, stimulants and foods are also analysed. It takes weeks or months to complete this third phase of the clinical trials; long-term data are collected over a period of up to one year.
During all phases of the clinical trials, everything is done to ensure the test persons are not put at any avoidable risk.
last update: 11 Jan 2012