Handbook for Clinical Research

This book delivers the practical insights and expert tips necessary for successful clinical research design, analysis, and implementation. It first covers the basics of research design: the variety of ways in which studies can be organized to address questions of association or causation; the appropriate sequencing of studies in a particular area to move most efficiently from demonstration of concept to a definitive and rigorous trial; methods and appropriate rigor of control conditions; retrospective and prospective trials; qualitative and quantitative analyses; and methods for summarizing, evaluating, and reporting clinical research in a particular area. Then, the book presents a discussion of selecting the correct statistical approach and when to consult a statistician. It reviews the varieties of data types; descriptive and inferential statistics; methods for demonstrating associations, hypothesis testing, and prediction; specialized methods, such as survival modeling; and specialized methods for epidemiological studies and measure construction. Further, the book includes a number of chapters on developing successful grant applications from planning and seeking consumer input to developing specific sections of research grant proposals, the project budget, and ancillary materials. The final chapters of the book cover the nuts and bolts of the timely and successful completion of the research project; developing procedural manuals and case report forms; collecting, managing, and securing data; operational structure and ongoing monitoring and evaluation of the project; and ethical and regulatory concerns in research with human subjects.