Different phases in clinical research

Clinical research can only be initiated  once  tests on cell cultures and  animal models  provide positive results.

Clinical research usually consists of 4 phases. The next phase can only be started when the previous was successfully ended.  This also means that not all products are made available.

Phase I

Phase I studies attempts to answer  specific questions like: how should this new drug  be administered, how often and what is  a save dose?  Phase I research is in general conducted on healthy volunteers. For oncology drugs  only patients are participated in phase I protocols.

Phase II

In Phase II, the activity of the product is studied, but also safety issues are examined.  A phase II study usually focuses on a specific type of cancer. 

Phase III

In this phase new treatments are compared with the standard treatment/medication. To establish a difference between 2 types of treatment, a large number of participants is required. When the results are positive, registration of the medication is requested, based on all research data obtained during  the phase I, II and III clinical studies.

Phase IV

After the medication is registered, follow-up research is planned to determine its place in the treatment as a whole. Further research is done to identify possible unknown adverse events.