Fundamentals of clinical research. Bridging medicine, statistics and operations (Q1031559)

The authors' book on methods and issues in clinical research is directed at biomedical researchers as well as statisticians. The monograph aims at two major objectives: Firstly, it addresses the integration of medical and statistical components of clinical research in order to create a logical flow of reasoning understandable for both the medical/biological and the statistical expert. Secondly, operational and practical requirements of real life settings in clinical research are taken into account, including regulatory considerations. At certain points the authors also refer to ethical implications of methodological issues. According to the subtitle ``Bridging medicine, statistics and operations'', the book has a practical approach, providing a lot of examples but also an insight into the more theoretical statistical background -- never becoming too abstract or requiring advanced mathematical knowledge. The topics covered in the book range from an introduction to different sources of variability, detailed descriptions of biomedical study types, the choice of samples as well as the treatments and experimental designs including questions of randomization, to statistical issues as inference and statistical testing providing also a comparison of the frequentist and the Bayesian approach. The final chapter offers an overview of the preclinical and clinical phases of a drug development process. The whole book is written in a convenient, comprehensible style but does not remain at an elementary level and is therefore useful also for readers having more advanced knowledge and experience in the field of clinical trials.