Drug studies on young, healthy people? What for? Why do you do that? Who is young and healthy does not need medication. But who does not want a safe and well-tolerated drug once it's ill? To guarantee these expected characteristics, various institutes and institutions conduct drug trials. Scope and conditions are prescribed by law (§§ 40, 41 AMG).
Course of a study
Before the tests on people, which are divided into four phases, a so-called preclinical phase is completed, that is, the drug is tested on the animal for its safety. Thereafter, the phases of the study on humans begin, which are structured as follows:
- Phase I: In this phase, the new drug is tested only on healthy individuals (at that time 10 to 30 subjects). The aim is to determine the tolerability of the substance in different dosages. In addition, the uptake in metabolism, distribution and excretion are examined.
- Phase II: The drug is first administered to a target group suffering from the disease to be treated. In addition, desired effects and undesired side effects are observed. At this time, typically 200 to 300 patients will participate in the study.
- Phase III: The therapeutic effect and the safety of administration are demonstrated in a larger group of patients (several 100 to 1000 subjects). The results of the study will be summarized in a report and the approval will be requested. The Federal Institute for Drugs and Medical Devices then decides on the granting of approval with the aid of this report.
- Phase IV: After a positive decision of the authority, the drug is approved and can be prescribed from now on by any doctor. In this phase, the general use also detects rare side effects.
So a study provides accurate information about the tolerability, effects and side effects of a new drug. However, problems arise with different interpretations or influencing of the test results due to incorrect subject selection, phase distortion, etc.