Clinical studies: what's behind them?

How do new drugs for the treatment of chronic itching, for example, come onto the market? Have you ever taken part in clinical trials? Why are they need carried out at all?

Studies are indispensable for gaining scientific knowledge for the development of new therapies and optimization of existing therapies.

The substance under investigation is first tested on animals and then on humans in four phases to determine its efficacy and safety: Phase I: on a small number, i. e. <100 healthy volunteers, Phase II: on approx. 100-500 symptomatic volunteers, Phase III: on up to 10,000 volunteers with relevant clinical disease symptoms, Phase IV: ongoing recording of any adverse effects after the drug has been marketed.

Out of approximately 10,000 substances, only about 10 enter Phase I, 5 enter Phase II, 2 enter Phase III and only one drug is finally approved.

It can take 10-15 years from the first tests of a substance to the marketing of the drug. Companies can only produce generics after patent protection has expired.

New, effective drugs are urgently needed to treat pruritus in particular. That is why studies are so important here.

Several medications have already been developed for the treatment of chronic pruritus. Biologics have become increasingly interesting in recent years, as they are biotechnologically produced drugs that resemble the body's own substances and specifically intervene in the body's processes. There is already an approved biologic for prurigo and others for use in treating pruritus are still under review.

The gold standard among studies to test drugs is the randomized controlled clinical trial, in which a group of patients with the therapy under investigation is compared with a control group. The control group either receives no therapy (placebo group), a different dosage of the same therapy or, for example, a standard therapy.

Test personsare urgently needed for studies. If you have the opportunity, we ask you to take part in studies so that effective medicines can be developed.

Have you already taken part in a study? Please write to us about it.