Clinical trials (or clinical studies) are scientific studies conducted with human participants to evaluate the safety and efficacy of new medical technologies, drugs, medical procedures and medical devices. They are an important part of the process of developing and evaluating new treatments and an essential step before new medical technologies can be introduced into medical practice.

The most important features of clinical trials (translation into German: klinische Prüfungen) include:

• Patient participation: Patients who voluntarily agree to participate in the study take part in clinical trials.
• Study objectives: The aim of a clinical trial can include evaluating the efficacy (German: Wirksamkeit) of a new drug or treatment, assessing the safety of a medical device, investigating the long-term effects of a treatment and much more. This involves evaluating whether certain predefined endpoints (German translation: Endpunkte) have been reached.
• Procedures and monitoring: Clinical trials are conducted according to a protocol that outlines certain procedures and evaluation criteria. Participants may be subject to medical examinations, treatments and regular health monitoring.
• Study phases: Clinical studies usually go through several phases, including Phase I (initial safety studies), Phase II (preliminary efficacy studies), Phase III (controlled clinical trials) and Phase IV (post-marketing surveillance).
• Results and data analysis: The results of clinical trials are analyzed and conclusions are drawn about the safety and efficacy of the product or method under investigation.
• Regulation: Clinical trials are strictly regulated by laws and regulations to ensure that the rights and safety of participants are protected and that the results are reliable. In Germany, for example, every clinical trial must be approved by an ethics committee and the competent regulatory drug authority.
• Publication of the results: The results of clinical trials are usually published in scientific journals (German: Fachzeitschriften) and are accessible to the general scientific and medical community. In Germany, all clinical trials conducted are recorded in the German Register of Clinical Trials.

Clinical trials play a crucial role in the development and improvement of medical practice by determining the efficacy and safety of new treatments. They also contribute to the long-term data collection on the effects of treatments and can facilitate improved standards of patient care.

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