Objectives: The aim of this paper is to show that even in a highly regulated area such as clinical research and development in pharmaceutical industry, there are needs and ample opportunities for statisticians and other medical informatics professionals to further creatively develop and implement methods in order to support the collection, analysis and interpretation of clinical data. Methods: The recently published Critical Path initiative of the US Food and Drug Administration discusses the decline in new drug submissions in the last decade and illustrates potential causes in the present clinical development process...
Keywords: Drug evaluation, drug approval, clinical trials, biometry, statistical m
01/2005 | Methods of Information in Medicine, Schattauer