Adaptive designs in phase II clinical trials

Abstract

Clinical trials play a very important role in the development process of new therapies. Recently there has been a rapid increase in theresearch and creation of new modern molecular agents, which makes necessary the development of more flexible and adaptive designs forthe implementation of clinical trials. The objective of adaptive designs is to ensure direct and dynamic control of the effectiveness and thesafety of a new treatment by allowing the adjustment of the elements of the study (i.e sample size), during the study, in such a way that wewill not sacrifice elements which are associated with the credibility of the study (i.e statistical power) and also issues which concern ethicalcharacteristics of the clinical trials.