What is a clinical study?

A little clinical study terminology

There are very different clinical studies.

Usually, "clinical studies" mean that research is carried out on humans.

Research on individual cells, cell clusters, tissues or animals is more commonly referred to as "basic research", "in vivo studies" or "translational studies". Clinical studies are then further differentiated according to the products, such as drugs, medical devices for treatments or as diagnostics, or purely scientific questions to generate new knowledge about the causes of diseases, for example.

Further distinctions between clinical studies

A further distinction must then be made as to whether authorised or unauthorised products are involved, or whether, for example, already authorised products are to be tested for a new indication (disease). A distinction is also made as to whether the clinical studies are analysing existing data, whether the research is generally simple and without pre-formulated assumptions (hypotheses), or whether existing assumptions are being tested.

Finally, the design of the study is determined. Elements such as randomisation, blinding, multicentre, prospective, controlled, control group, decentralised, digital are used here.

Ultimately, the best possible study must be scientifically designed for each product and each research question in order to generate scientific evidence that will convince experts and authorities and take into account the dignity and safety of all study participants.

The generic term "clinical studies" therefore also includes clinical investigations or other clinical investigations, drug trials or clinical studies of digital health applications (DiGA).

It certainly leads to confusion for some people that although DiGA and DiPA are a subgroup of medical devices, a scientific research question on this is referred to as a clinical study in the legislation and in the guidelines published by the BfArM, but not as a clinical investigation, according to the Digital Health Applications Ordinance (DiGAV), the DiGA guidelines of the Federal Institute for Drugs and Medical Devices (BfArM) and the Act to Accelerate the Digitalisation of the Healthcare System (Digital Act, DigiG). In ISO14155, however, "clinical investigations" (for medical devices) are equated with "clinical studies".

(as of spring 2024)

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