Fundamentals of Clinical Research

The scope of clinical research is to evaluate the effect of a treatment on the evolution of a disease in the human species. In recent years many introductory textbooks on clinical trial methodology have been published, some of which are excellent, in addition to a very extensive specialist literature. Here is a new book on methods and issues in clinical research. Its objectives can be summarized in three points. 1. Integrate medical and statistical components of clinical research. 2. Do justice to the operational and practical requirements of clinical research. 3. Give space to the ethical implications of methodological issues in clinical research. The book ends with a brief description of the drug development process and the phases of clinical development.

Here is a new book on methods and issues in clinical research

Inhalt
Viability of Biological Phenomena and Measurement Errors.- Distinctive Aspects of a Biomedical Study Observational and Experimental Studies.- Observational Studies.- Defining the Treatment Effect.- Probability, Inference and Decision Making.- The Choice of the Sample.- The Choice of Treatments.- Experimental Design: Fallacy of Before-After Comparisons in Uncontrolled Studies.- Experimental Design: the Randomized Blinded Study as an Instrument to Reduce Bias.- Experimental Designs.- Study Variants Applicable to More than One Type of Design: Equivalence Studies, Interim Analyses, Adaptive Plans and Repeated Measurements.- The Drug Development Process and the Phases of Clinical Research.