Clinical Study Design
Clinical studies are some of the most important studies in modern biostatistics. From academic institutions to biomedical institutions and the pharmaceutical industry, clinical studies are the most important tool for drug discovery, patient safety, medical affairs, epidemiology, and public health. For this reason, biostatistics professionals and anyone performing biostatistics should understand how clinical trial designs such as observational studies and clinical trials work and what research questions we can answer by implementing those designs.
This chapter is focused on a basic understanding of clinical trial design, how to differentiate different types of clinical studies, and how to relate all of this to statistics. Another very important aspect will be discussed, which is defining the essential documents for clinical studies: clinical trial protocols.
In this chapter, we’re going to cover the following main topics:
- Understanding clinical...
