Classification Assessment 306

In which phase of clinical trials are drugs compared against others on the market in an attempt to get a license?


Stats Clinical trials


Clinical trials are classified in the following way:-

Phase I

Phase I clinical trials involve only a small number of healthy people (possibly as few as 15-20). The focus is to evaluate the drugs safety, determine a safe dosage range, and identify side effects. 

Phase II

In Phase II clinical trials the drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

Phase III

In phase III trials the drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments (or placebos), and collect information that will allow the experimental drug or treatment to be used safely.

Phase IV

Phase IV trials (aka Post Marketing trials) are done after the drug has been granted a license. They gather further information on the drug in areas not addressed in the previous trials (e.g. Safety in pregnancy) and also to find other potential uses for the drug.