Clinical trials are scientific studies that test how well and how safely a medicine works. There are two types:

• Clinical trials: Here, a drug is tested that is either not yet approved or is being used in a different way than previously permitted. Additional examinations are permitted.
• Non-interventional studies (NIS): The medicine has already been approved and is used in the same way as in everyday life. There are no additional examinations or burdens for the participants.

Both types help to answer important scientific questions.

Clinical trials must comply with the Austrian Medicines Act (AMG) and an EU-wide regulation (EU Regulation 536/2014). This means that the rules are the same throughout Europe. Further information on the approval of clinical trials can be found here.

Clinical trials are divided into four phases:

• Phase I: Initial tests on humans. The aim is to find out whether the drug is safe and how it is absorbed by the body.
• Phase II: This phase tests whether the drug has the expected effect in human subjects.
• Phase III: This phase is particularly important for subsequent approval. The effect and safety are tested on many people.
• Phase IV: The drug has already been approved. It is examined to see how it performs in practice and whether it is suitable for further applications.

Before a clinical trial can begin, it must be approved by two bodies:

1. Authority (BASG)
2. Ethics committee

The following documents must be submitted for this purpose:

• Information on the manufacture and quality of the drug
• Results from animal experiments (on efficacy and tolerability)
• Results of previous studies, the exact schedule and patient education

As a rule, there are no studies with new drugs without prior animal testing. In most cases, many years of research have already been conducted before the first study with humans begins.

The authorities and ethics committees ensure that the studies are conducted safely and that the participants are well protected.

If you wish to participate in a study, you must be given detailed information in advance. This takes place in a discussion with the doctors conducting the study. You will then receive written information and must sign a declaration of consent.

Important:

• You will receive contact information in case you have any questions.
• You can withdraw from the study at any time without giving a reason.
• Your medical care will remain good and safe.