National and international guidelines recommend participation in clinical trials, which are offered by various study groups and organizations worldwide.
About clinical drug trials:
New active substances, e.g. for the treatment of breast cancer, undergo a multi-stage approval procedure including efficacy and safety tests. Prior to approving a new drug, the authorities responsible review the efficacy and safety data in detail. Therefore, accurate study data collection is of vital importance.
We design study protocols for drug studies as well as non-drug related aspects of breast cancer therapy and implement them in collaboration with experienced physicians.
Before patients receive a new drug, scientists and researchers investigate its effectiveness in cell cultures and in animals. Only if these tests are successful the drug could be administered to humans for the first time.
Active substances that have successfully passed the preclinical phase are tested in healthy volunteers in study phase I. The investigation is conducted within a clinical trial. It is examined how well a new drug is tolerated and which dosage range is suitable. In addition, it is observed how the body absorbs, distributes, metabolise and excretes the active substance.
In the case of particularly serious diseases such as AIDS or cancer, patients also take part in these early phases. The number of people treated in phase I trials is usually very small, with only a few dozen participants.
In phase II trials, patients are given the drug to test its effectiveness. During these studies, researchers also determine the most suitable and at the same time most tolerable dose.[
Phase III is the last study phase and the most extensive step towards the approval of a new drug: Several hundred to several thousand patients receive the active substance in a fixed dosage.
Advantageous phase III study results are the prerequisite for approval of a new drug. The responsible authorities examine the application for approval and the associated data set on efficacy and safety in detail. The carefully assessed benefit for patients is a time-consuming process.
After the drug has been approved, phase IV studies provide insights from daily clinical routine. The aim is to learn more about very rare adverse side effects and about efficacy in specific groups of people.
