Fundamentals of Clinical Research Bridging Medicine, Statistics and Operations /

• Main Authors: Bacchieri, Antonella (Author), Cioppa, Giovanni Della (Author)
• Corporate Author: SpringerLink (Online service)
• Format: Electronic eBook
• Language: English
• Published: Milano : Springer Milan, 2007.
• Series: Statistics for Biology and Health,
• Subjects: Pharmacy.; Medicine.; Health informatics.; Occupational medicine.; Statistics.; Medicine & Public Health.; Health Informatics.; Statistics for Life Sciences, Medicine, Health Sciences.; Occupational Medicine/Industrial Medicine.

The scope of clinical research is to evaluate the effect of a treatment on the evolution of a disease in the human species.The treatment can be pharmacological, surgical, psychological/behavioral or organizational/logistic. The disease, intended as an impairment of a state of well-being or a conditi...

Table of Contents:

• 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.