Diana Isabella Dmytrow
The aim of this theoretical and conceptual analysis is to highlight the relevance of clinical trials in terms of their health economic and medical benefits for Germany. Clinical trials constitute a sub-category of pharmaceutical research and are conducted on trial participants across three distinct trial phases, in strict compliance with legal requirements and within a rigorously controlled environment. As clinical trials account for a significant proportion of the healthcare sector, their absence would result in an economic loss; furthermore, from a health economics perspective, this could lead to an increase in expenditure by health insurance providers. The Tegenero scandal in 2006 revealed that risks to trial participants remain a possibility even today. To minimise these risks, a ban on the simultaneous administration of medicinal products in clinical trials should be enshrined in the Medicines Act, so that trial participants or patients do not receive the investigational medicinal product at the same time, thereby reducing the risks.