Clinical study coordination:

Mag.a Magdalena Hlava (on leave)
Johanna Nutz

Tel: +43 1 40400 27370
E-Mail: study-genpsy@meduniwien.ac.at

Phase I-IV

A clinical study is a pre-planned well-defined set of tests used to assess the efficacy and safety of a new drug, intervention or medical product. The study phases I-IV denote how far along testing is for a particular product.

Phase I:

Phase I is utilized to assess if a drug is safe for use in humans while providing pharmacokinetic and pharmacodynamic information. Phase I studies are typically performed in specialized centers, under vigilant medical supervision. Primarily healthy volunteers are tested, but persons with specific medical issues may also be tested in order to glean specific dosing and toxicity information.

Phase II:

Phase II studies are performed in patients suffering from the disorder that the drug or intervention intends to treat. During this phase information on dosage and safety are acquired. Drugs or interventions must be deemed safe and the appropriate dose range must be determined before phase III testing can commence.

Phase III:

Phase III tests are performed in larger groups of patients for whom the drug or intervention is intended. The goal of this phase is to assess efficacy and safety in appropriately powered and timed studies by trained study physicians. Drugs are tested against placebo and against active comparators, which are typically the current state of the art treatment of the disease of interest. If a drug or intervention proves safe and effective in phase III studies, it may be considered for approval by regulatory authorities.

Phase IV:

Phase IV studies are implemented after approval. They serve to observe efficacy and safety in the “real-world” setting.

Non-interventional studies (NIS):

Non-interventional studies are purely observational studies (i.e., no drug or intervention is provided).