Research in four phases

 

If scientists, doctors or researchers test new drugs or medical techniques on human beings, that is called clinical research.

To make sure that these studies are conducted carefully and ethically, there are rules that all scientists, doctors and researchers must comply with.

 

 

Phase I: Is the new drug safe and what is the right dosage? In this phase, the new drug is tested on a very small number of (healthy) people.

 

Phase II: Is the new drug effective and are there any side effects? In this phase, the drug is tested on a much larger group of people and the participants are selected because they have the condition for which the new drug is to be used.

 

Phase III: Is the new drug more effective than existing treatment? In this phase, the test group is split into two. One group is given the new drug. The other group is given a placebo (= dummy drug) or an existing drug.

 

If research findings show that the drug’s active ingredient is effective, the next stage is to apply to a national or international expert body for approval. In Europe, that is the EMA – the European Medicines Agency. Phase IV can only start if they give their approval.

 

Phase IV: Does the new drug work in the long term too? The new drug is now safe enough to be given to patients. Each patient who is prescribed the drug by their doctor is monitored in the long term, to see whether the new drug can be improved.