ABSTRACT
A clinical trial, also referred to as clinical study or clinical research, is the overall process of evaluating the safety and efficacy of a medical product or an intervention in humans. This chapter explains the basic elements of clinical research, as they apply to the development of medical products. It begins with a brief history of the field, provides an overview to introduce concepts and terms used in clinical research, and progresses to a section on clinical planning. The key to successful clinical research programs in this ever-changing and fast-paced environment is effective clinical development planning. A clinical trial includes humans willing to participate and receive either the product or, perhaps, the placebo. Clinical laboratory data are important to all clinical trials. The chapter concludes with a discussion of ethical behavior and the importance of ensuring the well-being of human subjects enrolled in clinical research.
