ABSTRACT
This chapter discusses the design of clinical trials relative to drug development. The principles of protocol design, however, remain the same no matter what the nature or purpose of the investigation. Carefully defined groups of patients or subjects are selected according to proper experimental design to eliminate biases in the assessment of the outcome of treatment. The components of a good study design are considered in the following subsections. Randomization prevents bias and contributes to equal distribution of patients and validity of statistical analyses. The chapter provides a series of procedures in time sequence is presented from initiation of the screening of subjects/patients through posttreatment. Screen Phase For the investigator to determine clearance of a subject/patient for entry into the study, screening usually includes a physical exam, history, general and specific laboratory tests, inclusion/exclusion criteria. The means of recording the data obtained during clinical trials are through the use of properly designed forms called data collection forms, case report forms.
