Clinical trials

There is a lot to consider and discuss in order to get it right the first time.

In clinical trials, we differentiate between clinical trials in accordance with the German Medicinal Products Act, clinical trials in accordance with Article 62 (1) of the EU Medical Device Regulation (MDR (EU) 2017/745), other clinical trials in accordance with Article 82 (1) of the MDR (EU) 2017/745 and studies with food supplements, cosmetics or purely scientific studies, e.g. to gain knowledge.

Clinical trials are necessary when existing data cannot demonstrate safety, efficacy, benefit or the benefit-risk ratio. This is the rule for new products.

In addition to the precise assessment of an innovation and its classification as a medicinal product, medical device including risk classification, food supplement or cosmetic, other factors must be taken into account from the outset.

This includes knowledge of the data to date, assessment of the market and thus of the need, the state of science, and the therapy options and guidelines that already exist. Only then is the time-consuming work worthwhile in order to plan an efficacy proof and the benefit or additional benefit with a relevant question for a clinical study.

Other important factors that need to be considered in advance are the required level of evidence, the clean assessment and positioning of an innovation or selection of a relevant indication area to ensure reimbursability by health insurers or by patients.

‍