Principles of Clinical Research
A general understanding of clinical research is necessary both to thoughtfully read orthopedic literature and to contribute to literature by conducting research. This chapter addresses the different types of clinical research, as well as the definitions of the various levels of evidence. Then, a brief history of regulatory guidelines pertaining to human research is provided, along with an overview of current regulatory mechanisms. Other general considerations such as funding sources and challenges of conducting research are also addressed. Finally, a primer of basic statistical principles and calculations frequently used in clinical research is included at the end of the chapter.