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General Information on Clinical Studies

Background and definitions
A clinical study – also known as a “clinical trial” – is a planned systematic examination carried out on test persons with a view to analyzing, evaluating or demonstrating the efficacy, safety and tolerability of one or more form of treatment, e.g. of a drug, a medical device or a medical procedure.

Clinical studies are carried out both in clinics and in outpatient settings. Owing to their medical significance and high international ethical, legal and administrative requirements, exceptional care must be taken with these studies. There are specific requirements for conducting clinical studies with drugs and medical devices. Examples of these are the Good Clinical Practice (GCP) guidelines and the ISO 14155 standard, both of which help to guarantee the ethical and scientific quality of clinical studies.
Clinical studies can be broken down into a number of different areas, including planning, clinical practice, data management, statistical evaluation and publication.

Types of clinical studies
The term “clinical study” extends to any examination conducted with test persons whereby individual data relating to each test person is measured.

Interventional studies
All clinical studies involving drugs or medical devices requiring significant intervention in the treatment of the patient – e.g. with random treatment allocation, new therapy procedures, additional examinations or operations – must be carried out in accordance with the GCP guidelines (drugs) or the ISO 14155 standard (medical devices).

Non-interventional studies (NIS)
Non-interventional studies are those that do not involve significant intervention in the treatment of the patient and also do not involve random treatment allocation, additional invasive or study-related treatments or examinations. In the case of uncertainty, an ethics commission is to be consulted. NISs can only be conducted on products that are already registered or certified in the country in which the study is being conducted and that are being used in accordance with the terms of their approval and certification.