Hypotheses, Data, Stratification

Abstract

Over the past decades the randomized clinical trial has entered an era of continuous improvement and has gradually become accepted as the most effective way of determining the relative efficacy and toxicity of new drug therapies. This book is mainly involved in the methods of prospective randomized clinical trials of new drugs. Other methods for assessment including open-evaluation-studies, cohort- and case-control studies, although sometimes used, e.g., for pilot studies and for the evaluation of long term drug-effects, are excluded in this course. Traditionally, clinical drug trials are divided into IV phases (from phase I for initial testing to phase IV after release for general use), but scientific rules governing different phases are very much the same, and can thus be discussed simultaneously.