Adaptive Seamless Designs in Clinical Trials

Abstract

Clinical Trials as an integral part of drug development and health improvement, have led tomany breakthroughs in disease prevention and treatment in the last half-century. The increasingcomplexity in the demands and goals of drug development during the last decades has led tomore flexible and effective clinical trials. These trials are based on designs with certaincharacteristics, which allow modifications in the protocol in order for more effective and reliableresults to be derived. These designs are called adaptive designs. Seamless designs are a specificinnovative type of adaptive designs which combine in one phase, objectives that traditionallyshould be addressed in separate phases of a clinical trial. These designs enjoy the majoradvantage of conducting a clinical trial at low cost in reduced time frames being effective andreliable at the same time. This thesis is an attempt to review Adaptive Seamless Designs andprovide as much as possible information about their structure, use, concerns and implementation.