Introduction to Statistics in Pharmaceutical Clinical Trials

Introduction to Statistics in Pharmaceutical Clinical Trials is presented in the context of clinical trials conducted during pharmaceutical drug development.   This novel approach teaches the computational steps needed to conduct analyses. It also provides a conceptual understanding of how these analyses provide information that forms the basis for decision making throughout the drug development process.   This textbook conveys:

• why, and how data are collected in clinical studies.
• how these data are summarized and analyzed.
• what the results mean in the context of the clinical research question.
• how the results are communicated to regulatory agencies and to the scientific and medical communities.

This book is invaluable to health professionals entering the pharmaceutical, biotechnology, and contract research organization industries who wish to gain a broader understanding of study design, research methodology, and statistical analysis and interpretation in clinical trials.