Clinical drug trials
A Clinical Trial is a defined, scientific investigation into the efficacy and safety of a drug, a new medical procedure or a new medical device. Depending upon the stage of development of a drug, a clinical trial is divided into Phases I to IV.
As a rule, this involves a study conducted on healthy people. The new active agent is trialled on volunteers under strict medical supervision – usually in special facilities. The aim is to determine provisional harmlessness of use and to obtain an initial picture of the pharmacokinetic and pharmacodynamic profile of the drug. It is also possible to include people with specific diseases, in order to analyse metabolisation of the substance or dose tolerance in this disease.
Normally, this phase involves the first use in patients, in order to check efficacy and relative harmlessness in people suffering from the disease or symptoms, for which the drug is intended. Dosage and dose finding studies are conducted during this phase. Once Phase II has been completed, the effective and harmless dose of the active agent should be established.
The aim of this phase is to conduct studies on patients in hospitals and selected GP practices in accordance with a set trial protocol, to check efficacy and also to observe the frequency of any side-effects. So-called comparative studies are also conducted to check whether the active agent offers any advantage over other preparations or treatment options. Once Phase III has been completed, the trial documentation can be submitted to the competent authority for authorisation.
Phase IV studies describe the study of drugs that are already approved, where the approved therapeutic application is extended to include additional investigations or interventions.
Non-Interventional Studies with Pharmaceuticals (NIS)
These clinical studies were previously called "post-marketing surveillance studies". Although they are regulated by Medicines Act (AMG) they do not constitute a clinical trial under pharmaceutical legislation, since no additional interventions take place. They can serve to increase the safety or efficacy of approved drugs.