What is a clinical trial?
Usually drugs or drug combinations which have not yet been approved for the respective disease are tested in clinical trials. Likewise drugs may be tested which, while approved for certain diseases, are not approved for the disease from which patients are suffering in that trial.
Trials generally undergo 4 phases.
- the drug is used in humans for the first time (first-in-man),
- All patients participating in the study generally receive the drug with the active ingredient. This phase is about gaining important data on the safety and tolerability, to determine the optimal therapeutic dose and to get a first impression of the effectiveness of the therapy.
- Once this data is available, a drug can go into the second phase of testing.
- the task is to gather further data on the efficacy of the drug and additional data on safety and tolerability.
- Usually, also in this study phase, all patients receive the drug to be tested. Rarely Phase II study are randomized,
- which means that some of the patients receive standard treatment while the other part receives the drug with the new active ingredient or the new combination.
- Phase III is eventually about showing that the new drug is better or just as good as the standard therapy.
- These trials are always randomized. Randomization can be open (both, the patient and the physician know which drug the patient receives) or blinded (neither the doctor nor the patient knows which drug is given).
- Neither doctor nor patient have an influence in the decision over which treatment the patient will receive. The decision is subject to statistical calculations and is made by a computer system.
Zulassungsantrag bei Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) nach Phase II und III. Erst nach Zulassung ist das Arzneimittel in der Apotheke erhältlich.
- After admission
- Recognizing rare side effects
- Comparing the new medication to already existing medicine, gathering new information in a very big group of patients