Phase II studies

In Phase II studies anti-tumour activity of a new drug or method is the endpoint. There are various statistical designs, including 14-60 patients on average. In the case of new drugs, where the exposure of patients to potentially inactive agents should still be avoided, the design is aimed to exclude activity with a level of certainty, instead of showing activity.

With the emergence of drugs that create tumour dormancy rather than cell kill, the endpoint of time to progression becomes important. This is the time from the start of treatment until the first evidence of tumour progression. In addition, Phase II studies can provide information on side-effects related to cumulative drug dose.

0 0

Post a comment