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Clinical trials are crucial for developing safe, effective and optimized therapies for patients and driving medical progress.
The development of new drugs begins with basic research, which aims to better understand diseases and their mechanisms and to describe new potential mechanisms of action. This is followed by the search for potential active ingredients using methods such as computer-aided drug design (CAD), chemical synthesis and natural product isolation.
A modern approach in drug development is the so-called "biologicals", biotechnologically produced drugs that resemble the body's own substances and specifically intervene in bodily processes.
Once a potential active ingredient has been identified, pharmacological screening follows, in which the rough properties of the substance are analyzed. These studies are carried out both in vitro, on cell clusters and isolated organs, and in vivo, usually on small animals. The subsequent preclinical phase comprises comprehensive animal studies that enable predictions to be made about the reactions of the human body to the new active substance.
The clinical development of a new drug is divided into four phases:
The entire development of a drug usually takes 10 to 15 years and costs several hundred million euros. Out of 10,000 synthesized compounds, only one usually makes it to market approval. Only 10% of human trials are discontinued due to adverse effects.
The gold standard in clinical research is the randomized controlled clinical trial (RCT). In this method, a group of patients receiving a specific therapy is compared with a control group. This control group can either receive no therapy (placebo), a different dosage of the same therapy or a different therapy. The allocation of patients is randomized in order to avoid bias. The previously defined target values are then observed and measured.
Participation requirements for study participants:
Adverse events:
An "adverse event" (AE) is any negative occurrence in a study participant, regardless of whether it was caused by the treatment.
Procedure of the study:
1. information and consent of the study participants
2. review of the inclusion and exclusion criteria
3. treatment according to study protocol
Financing:
Clinical trials can be funded in two ways. On the one hand, there are commercial studies that are financed by the industry as part of drug development. The aim here is to provide evidence of efficacy and tolerability in order to obtain approval.
On the other hand, there are non-commercial studies in which the focus is on gaining scientific and therapeutic knowledge. These are often initiated by clinically active physicians, so-called Investigator Initiated Trails (IIT). Such studies can be supported by funding, e.g. from the German Research Foundation (DFG), the Federal Ministry of Education and Research (BMBF) or German Cancer Aid.
Goals:
Clinical studies serve to gain scientific knowledge for the development of new therapies and the optimization of existing therapies in order to improve their efficacy and safety.
Conclusion:
Clinical trials play a central role in the development and optimization of therapies by comprehensively testing the safety, efficacy and side effects of new drugs. The structured process in four phases - from testing on healthy volunteers to long-term observation after market launch - ensures that only high-quality and safe therapies are approved. However, this process is expensive and usually takes 10 to 15 years. Only a small proportion of the active substances tested ultimately achieve market approval.
