Review of "Fundamentals of Clinical Trials" by LM. Friedman, CD. Furberg and DL. DeMets

The book is preceded by two editions (1981 and 1985) and well backed by the experience and prestige of its authors. Clinical Research, a branch of Applied Research, finds in clinical trials the most definitive tool for evaluation of its actual applicability. The book is divided in 19 chapters, each setting up unequivocally the Fundamental Point to be treated, as for example the introductory Chapter 1: A properly planned and executed clinical trial is a powerful experimental technique for assessing the effectiveness of an intervention. A clinical trial compares the effect and value of intervention(s) against a control in human beings. Intervention refers either to a drug, a procedure or a technological device, thus implying that biomedical engineering scientists and professionals might be involved in it. Clinical Research always presents early stages where the laboratory work is mandatory. This book emphasizes the concept all along, so placing the clinical trial in its proper hierarchical perspective. There is laboratory work during drug, device and/or procedure development, animal studies and early tests in small number of human beings. Case reports, typical of the hospital, find their place as a warning of adverse effects or as a flag of an unexpected beneficial effect.In Chapter 2 the authors emphasize that a clinical trial must have a primary question. It should be carefully selected, as any subsidiary question must be, too. Otherwise, the investigators may lose the track. Chapter 3 deals with the study population, underlying the importance of unambiguous eligibility criteria, the latter having a direct influence on the recruitment of participants and, thus, on the final number involved in the project (which may end up with not enough data). Chapter 4 outlines the basic study design; it stresses the demand of a control group and the need of randomization for assigning participants to control and intervention groups.An extremely important subject is the randomizat