Design, implementation, and interpretation of clinical trials

Abstract

The findings from Phase III randomized clinical trials (RCTs) conducted since the 1950s have lead to major advances in the clinical treatment and prevention of breast cancer. The impact of these clinical trials is best evaluated by examining the substantial decline in mortality attributed to breast cancer in countries that have accepted and applied the results from Phase III clinical trials in the broader clinical setting [1]. Concomitant with the wider acceptance of the merits of RCTs for testing new therapeutic interventions, there have been important developments in the biostatistical methods utilized in RCTs that reflect recognition of the integral role of statistical science in clinical research. © 2010 Springer Berlin Heidelberg.